Drugs, Health Technologies, Health Systems
Peer-Reviewed Article
Canadian Trends in Estimated Drug Purchases and Projections: 2024 and 2025
Mina Tadrous, Kevin Z. Wang, Shanzeh Chaudhry, Cherry Chu, Fiona Clement, Jason R. Guertin, Michael R. Law, Wade Thompson, Tara Gomes, Kaleen N. Hayes
Abstract
Background: Data on trends in the pharmaceutical market remain limited. We offer an annual update on estimated drug purchases in Canada and highlight key factors that could impact future spending. This information aims to assist public and private decision-makers in forecasting the growth of national drug purchases.
Methods: We conducted a retrospective time-series analysis of annual estimated drug purchases across Canada between 2001 and 2023 using IQVIA’s Canadian Drugstore and Hospital Purchases Audit. We calculated total estimated drug purchases and relative percentage change annually, stratified by sector (retail and hospital), and forecast annual spending to 2025. We also assessed recent drug approvals, policies, or legislation that may influence drug spending.
Results: Total estimated drug purchases for 2023 were approximately $43.5 billion, 13.7% higher than in 2022 (retail purchases: 12.9% growth; hospital purchases: 17.7% growth). Overall, expenditure on the top 25 high-cost drugs accounted for 32.5% and 53.3% of total spending in the retail and hospital sectors, respectively. Pharmaceutical spending has grown over the past 2 decades, with an annual average growth of 5.8% and 8.2% in the retail and hospital sectors, respectively. Drug expenditure in the retail sector is expected to increase annually by 10.9% to 10.1% and spending within the hospital sector is expected to increase by 14.6% to 12.9% for 2024 and 2025, respectively.
Interpretation: This study indicates evidence of accelerated growth in overall estimated drug purchases, likely driven by the increasing use of new diabetes and obesity treatments. Continued growth in drug purchases is projected across the Canadian market, which will be influenced by new approvals of specialty and oncology drugs as well as generic and biosimilar versions of the top 25 drugs. Without measures to address this ongoing increase in pharmaceutical spending, there may be a need to reallocate funds from other public sectors or shift costs to private industry and patients. The potential opportunity costs of rising pharmaceutical spending warrant careful consideration.
For author information, refer to Appendix 1.
Introduction
Total health care spending in Canada was forecasted by the Canadian Institute for Health Information (CIHI) to reach more than $344 billion in 2023, representing 12.1% of the country’s gross domestic product.1 Spending on prescription drugs was expected to account for 13.9% of national health care purchases, which was an increase of 3.0% from the previous year’s projections.1
In 2022, our group published a second update highlighting spending on drugs in Canada.2 Briefly, we found that drug spending increased on average by 5.4% annually in the retail sector and by 7.4% annually in the hospital sector between 2001 and 2021.2 We projected that spending was likely to continue increasing until at least 2023.2 Although drug spending was historically driven by simple, small molecule medications, our results highlighted that complex therapies, such as biologics and biosimilars, were now the key contributors to drug spending.2 Furthermore, we projected that drug spending for the years 2022 and 2023 would increase annually by 5.6% and 5.3%, respectively, in the retail sector and by 9.4% and 8.8%, respectively, in the hospital sector.2 These projections were based on the information available at the time regarding novel treatments being approved by Health Canada and the US FDA combined with historical growth in spending.
Budget planning is an annual process that requires forecasting potential growth; therefore, this analysis aims to assist decision-makers and formulary managers in shaping their yearly budgets and strategies. Approvals of novel pharmaceutical technologies are likely to impact future budgets, so an annual update on spending forecasts and horizon scanning is essential. Independent assessments of drug spending across the country can help public and private decision-makers better anticipate how various factors, including new technologies, may affect spending trends. In this updated report, we present current trends and forecasts for retail and in-hospital estimated drug purchases across Canada as well as a horizon scan of upcoming drugs that could influence future spending trajectories.
Methods
Drug Purchases and Projection
We conducted a retrospective time-series analysis of annual estimated drug purchases (i.e., drug purchases) across Canada between January 1, 2001, and December 31, 2023, using IQVIA’s Canadian Drugstore and Hospital Purchases Audit. These data estimates purchasing costs and unit volumes of all pharmaceutical products purchased by the Canadian retail and hospital sectors.3 This audit is derived from a sample of outlets within these sectors (more than 33% of retail and 86% of hospital sectors) in each province and territory, which are projected to represent total pharmaceutical purchasing at the national level using proprietary methods. We included all pharmaceutical purchasing of all dosage forms and formulations over the study period. Purchasing may be made through a wholesaler or directly from the manufacturer, and therefore may include mark-ups, but does not capture discounts and rebates. Although the Canadian Drugstore and Hospital projections will not capture any subsequent rebates or volume discounts credited to the outlets afterward, it does reflect all up-front discounts for each specific invoice. Due to the aggregated nature of the data provided, research ethics board approval was not required.
We describe total estimated drug purchases across Canada annually (using calendar years) over the study period, stratified by sector (retail versus hospital). We calculated the annual growth in purchases as the relative percentage change from the previous year. We used exponential smoothing models and applied Holt’s linear method to forecast annual estimated pharmaceutical purchases in 2024 and 2025. Costs were reported as nominal annual costs, and nominal costs were used for the projection models. In a sensitivity analysis, we inflated annual costs before 2023 to the 2023 values using all-items consumer price indexes.4 Finally, we identified the 25 medications with the highest total purchases in calendar year 2023 within the retail and hospital sectors separately.
Horizon Scan
An environmental scan of global and national drug spending and pipeline reports was conducted to identify therapeutic classes with potentially major impacts on pharmaceutical spending.5-13 All medications approved by Health Canada in 2023 and the first quarter of 2024, as well as generic drugs and biosimilars currently under review, were assessed for anticipated impacts.14 New drug approvals by the US FDA in 2023 and the first quarter of 2024 were also reviewed to identify drugs that may soon enter the Canadian market.15
Drugs with a potential for high impact on future spending (via upward pressure or downward pressure) were flagged based on the following criteria: disease prevalence, current medication use and availability in the therapeutic area, and anticipated cost. Our approach was consistent with earlier work we conducted.2,23,25,26 Based on the list of drugs with the highest potential for impact on the Canadian market, the authors used this information to highlight some drugs that are likely to impact forecasted spending.
Results
Trends in Canadian drug purchases from 2001 to 2023 in the retail and hospital sectors are presented in Figure 1 and Figure 2, respectively. Graphs that include values accounting for inflation can be found in Appendix 2 (Figure 4 and Figure 5).
Figure 1: Total Medication Purchases in Canada for the Retail Sector From 2001 to 2023 and Projected to 2024 and 2025
Note: The grey zone illustrates forecasted purchases in the retail sector (solid line) with 95% confidence interval estimates (dashed lines) for 2024 and 2025
Source: This figure is based on information licensed from IQVIA: Canadian Drugstore and Hospital Purchase Audit for 2001 to 2023 estimates of real-world activity. All rights reserved.
Figure 2: Total Medication Purchases in Canada for the Hospital Sector From 2001 to 2023 and Projected to 2024 and 2025
Note: The grey zone illustrates forecasted purchases in the hospital sector (solid line) with 95% confidence interval estimates (dashed lines) for 2024 and 2025.
Source: This figure is based on information licensed from IQVIA: Canadian Drugstore and Hospital Purchase Audit for 2001 to 2023 estimates of real-world activity. All rights reserved.
Overall Spending
In 2023, total annual estimated drug purchases in Canada grew 13.7%, reaching $43.5 billion (versus $38.3 billion in 2022). This growth far exceeded the previously forecasted rate of 5.9%.2 The retail sector accounted for 82.9% of estimated drug purchases in 2023 ($36.1 billion), and the hospital sector accounted for 17.1% ($7.4 billion). Retail and hospital purchases in 2023 increased from 2022 by 12.9% and 17.7%, respectively, with both rates exceeding our previously forecasted 2023 rates of 5.3% and 8.8%, respectively. Figure 3 illustrates the trends in annual change in purchases across both sectors.
Figure 3: Annual Growth (%) in Drug Purchases From the Previous Year for the Retail and Hospital Sectors, 2002 to 2023 and Projected Growth for 2024 and 2025
Note: The grey zone illustrates forecasted annual growth for 2024 and 2025.
Retail and Hospital Spending
Over the entire study period (2001 to 2023), average annual estimated drug purchase growth was 5.8% in the retail sector and 8.2% in the hospital sector. Total estimated drug purchases in the retail sector increased by 243%, increasing from $10.5 billion in 2001 to $36.1 billion in 2023. Drug purchases grew even more sharply in the hospital sector, by 452%, from $1.3 billion in 2001 to $7.4 billion in 2023.
In the retail sector, growth was stronger in the earlier years, with an average annual increase of 6.7% between 2001 and 2011 compared to 5.1% from 2012 to 2023. Notably, 2011 was the only year with a decline in retail drug purchases (−2.9%). In contrast, in the hospital sector, estimated drug purchases grew consistently, with an average annual increase of 6.5% between 2001 and 2011, which increased to 9.6% from 2012 to 2023, without any year of decline.
In recent years, drug purchases in both sectors have shown significant growth. In the retail sector, estimated drug purchases rose by 3.8%, 7.3%, 7.0%, and 12.9% in 2020, 2021, 2022, and 2023, respectively. Hospital-administered drug purchases saw even larger increases, with growth rates of 6.9%, 12.4%, 14.7%, and 17.7% in 2020, 2021, 2022, and 2023, respectively. These recent trends indicate a substantial acceleration in spending, particularly in the hospital sector, reflecting the growing demand for newer and more expensive treatments.
Drug Expenditure Forecast for 2024 and 2025
We forecast a yearly increase (all sectors combined) in estimated drug purchases of 11.5% (95% confidence interval [CI], 7.7% to 15.3%) in 2024 and 10.5% (95% CI, 3.3% to 17.8%) in 2025 (Figure 3). We project that purchases in the retail setting will increase by 10.9% (95% CI, 7.2% to 14.5%) and 10.1% (95% CI, 3.0% to 17.1%) annually for 2024 and 2025, respectively. We project that hospital-administered drugs will increase annually by 14.6% (95% CI, 10.2% to 19.0%) and 12.9% (95% CI, 4.7% to 21.1%) for 2024 and 2025, respectively. In absolute costs, we forecast the total spending will increase to $44 billion (95% CI, $41.2 billion to $46.9 billion) for retail purchases and $9.6 billion (95% CI, $8.9 billion to $10.3 billion) for hospital purchases by 2025 (Figure 1 and Figure 2).
Top 25 Drugs by Overall Purchases in 2023
Table 1 lists the top 25 drugs by estimated drug purchases in retail and hospital settings across the country for the year 2023. Semaglutide ($1.9 billion), infliximab ($1.2 billion), and ustekinumab ($912 million) were the top 3 highest expenditure drugs in the retail setting, whereas pembrolizumab ($797 million), daratumumab ($548 million), and nivolumab ($328 million) were the top 3 drugs in the hospital setting. Only 3 drugs were in the top 25 of both lists: aflibercept (a vascular endothelial growth factor-A antagonist) at number 5 in retail spending and number 22 in hospital spending, ibrutinib (a small molecule inhibitor of Bruton tyrosine kinase) at number 19 in retail spending and number 17 in hospital spending, and bictegravir-emtricitabine-tenofovir-alafenamide (a complete regimen for the treatment of HIV-1 infection) at number 22 in retail spending and number 18 in hospital spending. Overall, total purchases for the top 25 drugs in both markets in 2023 accounted for $15.7 billion ($11.7 billion and $4.0 billion in retail and hospital sectors, respectively), which accounted for 32.5% and 53.3% of total spending in each sector, respectively.
Table 1: Top 25 Drugs by Spending in Retail and Hospital Settings for the Calendar Year 2023 and the Trend (Upward or Downward) Compared to 2022
Rank | Retail | Hospital | ||||
|---|---|---|---|---|---|---|
Drug | Total | Trend | Drug | Total | Trend | |
1 | Semaglutide | $1,943,826,972 | ↑ | Pembrolizumab | $797,330,603 | ↑ |
2 | Infliximab | $1,220,620,565 | ↑ | Daratumumab | $548,362,800 | ↑ |
3 | Ustekinumab | $911,623,762 | ↑ | Nivolumab | $328,229,269 | ↑ |
4 | Adalimumab | $910,774,341 | ↑ | Durvalumab | $233,128,120 | ↑ |
5 | Aflibercept | $809,989,780 | ↑ | Hemagglutinin (nonspecific) | $159,388,313 | — |
6 | Lisdexamfetamine | $500,293,173 | ↑ | Rituximab | $157,456,996 | ↑ |
7 | Empagliflozin | $482,576,566 | ↑ | Trastuzumab | $143,118,079 | ↓ |
8 | Methylphenidate | $475,924,758 | ↑ | Vaccine, HPV, type-6, 11,16, 18, 3 | $127,130,442 | ↑ |
9 | Risankizumab | $379,876,952 | — | Ipilimumab | $117,598,712 | ↑ |
10 | Vedolizumab | $354,293,254 | ↑ | Axicabtagene ciloleucel | $113,451,433 | ↑ |
11 | Budesonide-formoterol | $310,778,564 | ↓ | Osimertinib | $111,948,035 | ↑ |
12 | Rivaroxaban | $300,840,969 | ↑ | Remdesivir | $110,329,682 | ↓ |
13 | Golimumab | $292,710,108 | ↑ | Pertuzumab | $101,301,685 | ↓ |
14 | Paliperidone palmitate | $259,288,605 | ↑ | Bevacizumab | $96,632,333 | ↑ |
15 | Dupilumab | $253,907,387 | — | Palbociclib | $93,978,366 | ↓ |
16 | Ocrelizumab | $252,864,488 | — | Vaccine, pneumococcal conjugate | $87,337,707 | ↓ |
17 | Rosuvastatin | $250,035,747 | — | Ibrutinib | $84,318,408 | ↓ |
18 | Etanercept | $237,193,968 | ↓ | Bictegravir-emtricitabine-tenofovir-alafenamide | $82,398,301 | ↓ |
19 | Ibrutinib | $234,951,456 | ↓ | Darbepoetin alfa | $75,559,363 | ↑ |
20 | Upadacitinib | $234,445,844 | — | Lenalidomide | $72,793,391 | — |
21 | Denosumab | $227,669,589 | — | Apalutamide | $67,014,664 | — |
22 | Bictegravir-emtricitabine-tenofovir-alafenamide | $221,362,467 | ↓ | Aflibercept | $64,480,865 | — |
23 | Sacubitril-valsartan | $218,419,431 | — | Measles virus, mumps virus, rubella vaccine live: varicella zoster | $63,680,919 | ↓ |
24 | Guselkumab | $217,796,935 | — | Trastuzumab emtansine | $61,400,260 | ↓ |
25 | Ranibizumab | $215,180,402 | ↓ | Oseltamivir | $61,286,075 | — |
Total of top 25 | $11,717,246,083 | $3,959,654,821 | ||||
Total 2023 spending | $36,083,388,476 | $7,422,483,251 | ||||
Proportion of spending on top 25 drugs | 32.47% | 53.35% | ||||
Note: The dashes indicate new entries to the top 25 drugs in 2023.
Horizon Scan
Global reports were reviewed to determine trends for drug spending in Canada (Appendix 2, Table 3). Here, we summarize major themes for new and upcoming therapies in Canada. We first highlight treatments we believe will have impact on increased spending (“upward pressure”) then discuss potential mitigating factors (“downward pressure”). A list of drug approvals for Health Canada and the US FDA in 2023 and the first quarter of 2024 are presented in Appendix 2, Table 4 and Table 5, respectively. Health Canada approved 81 drugs in 2023, compared to 73 in 2022.14 The FDA approved 55 novel drugs in 2023, compared to 37 in 2022.15
Potential for Upward Pressure
The drug pipeline remains dominated by oncology drugs. A novel drug, capivasertib (Truqap), was recently approved by Health Canada and the FDA for use in combination with fulvestrant for human epidermal growth factor 2–negative, hormone receptor–positive locally advanced or metastatic breast cancer. The drug is also undergoing late-stage trials for triple-negative breast cancer.9 Another breast cancer drug, abemaciclib (Verzenio), was initially indicated for advanced and metastatic breast cancer but has since been expanded for use in early breast cancer in 2022. This led to 1 of the highest growths in spending for oncology drugs.9 Vaccines to treat cancer have the potential to impact spending in the coming years, following the successes of the COVID-19 mRNA vaccines. These drugs may be on the horizon, and include V940/mRNA-4157 (indicated for high-risk melanoma), autogene cevumeran (a personalized vaccine for pancreatic ductal adrenal cancer), TG4050 (indicated for ovarian cancer and HPV-negative head and neck cancer), Tedopi (indicated for advanced non–small cell lung cancer), and VB10.16 (indicated for advanced cervical cancer).13
Certain therapeutic areas are likely to increase spending due to the prevalence of these conditions in the Canadian population. Drugs for type 2 diabetes mellitus (T2DM), notably semaglutide, were the top drugs in terms of spending in 2023. Ozempic (semaglutide injection) has a 95% market share of all glucagon-like peptide 1 (GLP-1) analogues, and expenditures increased from $13.5 million in 2019 to $434 million in 2022.1 Ozempic is 1 of 2 GLP-1 receptor agonists that are reimbursed by public drug plans in Canada. Despite having specific criteria limiting its use to T2DM for most payers, there has been increased non-T2DM use of Ozempic due to its effect on weight management.16 A new related drug, tirzepatide (Mounjaro), was recently approved and shown in early studies to be more efficacious than Ozempic for diabetes.21,22 Although this could lead to a shift toward prescribers favouring this drug, it is anticipated that spending on this class would remain similar.9 In terms of inflammatory conditions, there is potential for increased spending due to risankizumab and upadacitinib receiving additional indication approvals after initial market release. Risankizumab (Skyrizi) received new approval for Crohn disease and psoriatic arthritis in late 2022, whereas upadacitinib (Rinvoq) received approval for Crohn’s disease and ulcerative colitis in 2024.9 Dupilumab (Dupixent) was previously approved for atopic dermatitis and severe asthma, and received new indications in 2023 for atopic dermatitis in pediatric patients as young as 6 months old, and for prurigo nodularis and eosinophilic esophagitis.9 Regarding rare diseases — especially in cases in which there are no or few treatment options available — there are more therapies with high prices expected to increase overall spending. Although a single rare disease drug may not significantly impact total spending, the growing number of such drugs and their high price tags collectively contribute to a rising trend in overall expenditures. Notable examples include trofinetide (Daybue, indicated for Rett syndrome), iptacopan (Fabhalta, indicated for paroxysmal nocturnal hemoglobinuria), zilucoplan (Zilbrysq, indicated for myasthenia gravis), eplontersen (Wainua, indicated for hereditary transthyretin), metreleptin (Myalepta, indicated for lipodystrophy), and pozelimab (Veopoz, indicated for CHAPLE disease), which have estimated average costs upwards of US$2 million per patient per year.11,12
Potential for Downward Pressure
Newly approved or upcoming biosimilar drugs have the potential to exert downward pressure on drug spending. Biosimilar market share increased from 23.5% in 2022 to 35.8% in 2023.9 Ontario’s biosimilar transition policy mandated that Ontario Drug Benefit beneficiaries transition to biosimilars for glatiramer, etanercept, insulin lispro, adalimumab, insulin glargine, insulin aspart, infliximab, rituximab, and ranibizumab (Byooviz).9,17 This policy transition brings the largest payer in line with most other public payers in the country. The transition period ended in late December 2023, and we expect an impact in 2024 and upcoming years as biosimilar alternatives become more readily available.9,17 For T2DM, insulin glargine, lispro, and aspart have had new biosimilars introduced in recent years that could lead to reduced spending on insulin.9 Insulin lispro had the lowest penetration rates, which is likely due to a shortage that delayed the transition policies; in the coming years, the impact could be more evident.9 In the biosimilar drug pipeline, there are 2 biosimilars for ustekinumab (Wezlana and Jamteki), 2 biosimilars for aflibercept (Yesafili and Opuviz), and 2 biosimilars for eculizumab (Bkemv), all of which are expected to be approved in 2024.13 Also, there are biosimilars in development for mepolizumab (Nucala), which could result in reduced spending in the coming years once approved.9 Generic drugs are expected to continue reducing spending, with a number of new generics expected in 2024.
Interpretation
Spending on pharmaceuticals has grown considerably over the past 2 decades in Canada, leading to a total market size of more than $40 billion in 2023. The annual growth in spending reached 12.9% for retail estimated drug purchases and 17.7% for hospital estimated drug purchases in 2023, surpassing growth rates seen in the prior year (7% and 14.7%, respectively) and our forecasted growth rates (5.3% and 8.8%, respectively2). This trend was apparent in both the retail and hospital sectors. The single annual decrease in retail spending in 2011 has been attributed to many brand name drugs losing exclusivity in that time period; however, trends in spending did not recede in the following years, likely due to the subsequent entry of many new “blockbuster” drugs, such as direct oral anticoagulants, various diabetes medications, and biologics.24 In the retail sector, growth in annual spending reached the highest level in the past 2 decades. In the hospital sector, the growth was nearly as high as the record growth seen in 2019 due to expansion in the use of novel oncology treatments. This expansion in hospital spending is likely driven by new product approvals, higher market entry prices for new drugs, and growing utilization. For example, GLP-1 receptor agonists accounted for $1.4 billion in drug expenditures in 2023. Thus, we anticipate continued increases in the retail sector combined with accelerated growth in the hospital sector, leading to total annual estimated drug purchases nearing $54 billion by 2025. Importantly, the anticipated growth in the number of new therapies and associated costs will continue to put pressure on constrained government budgets across the country, leading to a need for strategies that balance access to novel therapeutics against limited resources.
It is expected that there will likely be pressure from growth of already-marketed drugs and other therapies identified in the pipeline to continue to impact the degree of change in spending in the coming years. Overall, we believe the growth in spending will be on the higher end of the predicted range in the outpatient retail setting. There has been a significant increase in the use of the blockbuster drugs for T2DM and obesity (Ozempic and Wegovy semaglutide injections). We believe the use of these drugs has not yet peaked and was curbed by the global shortage that occurred between October 2022 and April 2024. Specifically, concerns about off-label prescribing of semaglutide for weight loss in individuals without T2DM resulted in worldwide shortages spanning this period. As Ozempic supply became stable, other GLP-1 receptor agonists and related drugs, such as dulaglutide and tirzepatide, faced a shortage. These shortages indicate semaglutide drug spending did not reach its peak in 2023. Because semaglutide was the drug with the highest spending in retail environments in 2023 even with shortages, it will likely be the single largest driver in terms of increased retail spending on medications in the coming years. Therefore, it is important to continue monitoring the use of GLP-1 receptor agonists, dulaglutide, and tirzepatide to ensure appropriate use and manage spending.
The adoption of biosimilar formulations has the greatest potential for reducing drug spending, but the degree of reduced spending depends on their uptake in Canada. Many public drug plans in Canada require patients who have not previously used biologics to be initiated on a biosimilar formulation. These plans have introduced mandatory nonmedical biosimilar switching policies over the past several years for select originator biologics.17,18 In Ontario, Ontario Drug Benefit recipients who were on an originator biologic drug were required to transition to a Health Canada–approved biosimilar between March 31 and December 29, 2023, to maintain their medication coverage through the public drug program for the biologic drug.17 Some of the highest drug spending in retail and hospital settings in 2023 was on biologics; given Ontario’s large population (38% of the population in Canada), this policy is expected to influence national spending in the coming years.
Our analysis has limitations that warrant discussion. First, we do not have information on the confidential rebates that manufacturers provide to public and private drug plans or to hospital purchasers because these contracts are kept confidential. These discounts can be sizable; for example, pan-Canadian Pharmaceutical Alliance (pCPA) negotiations yielded $1.24 billion in savings in 2017–2018.19 However, our results represent the total spending in the current drug system, and we do not anticipate major differences in the proportion of rebates to total spending in recent years. The purchase prices do account for up-front discounts. Rebates may be re-invested in paying for future drug spending and thus are paid forward in spending. Additionally, rising prices have important consequences on patient co-pays depending on payment method and plan structure.20 Second, our data had no information on payers (i.e., public insurance, private insurance, or out-of-pocket) and thus only characterizes global spending and future impacts among all payers.
Conclusion
In 2023, overall estimated drug purchases in Canada rose more than anticipated, with similar trends observed in both the hospital and retail sectors. This growth was driven by increased utilization and the high costs of new therapies. These upward trends have persisted for several years, following the relatively flat growth experienced between 2009 and 2014. The rising costs, particularly for new treatments, underscore the ongoing need for rigorous assessment and price negotiation by public payers to ensure these expenditures provide good value for money. Additionally, the burden on uninsured individuals highlights the importance of addressing affordability and access for everyone living in Canada.
References
1.Canadian Institute for Health Information. National Health Expenditure Trends | CIHI. [accessed 2024 Jul 8]. https://www.cihi.ca/en/national-health-expenditure-trends
2.Tadrous M, Graili P, Hayes KN, Neville HL, Houlihan J, Clement F, Guertin JR, Law MR, Gomes T. Canadian Trends in Estimated Pharmaceutical Drug Purchases and Projections: 2023. Can J Health Technol. [accessed 2024 Jun 11]; 2(11). doi:10.51731/cjht.2022.512. https://canjhealthtechnol.ca/index.php/cjht/article/view/MT0002
3.Brogan IMS. Canadian drug store and hospital purchases audit database. Montreal: IMS Brogan. 2007.
4.Statistics Canada. Consumer Price Index, annual average, not seasonally adjusted.
5.US Food and Drug Administration. New Drug Therapy Approvals 2023 | FDA [accessed 2024 Jul 23]. https://www.fda.gov/media/175253/download
6.Wolfe B. 2023 Drug Plan Trends Report - How the repercussions of the pandemic are trickling down to drug plans. Benefits Canada. [accessed 2024 Jul 2]. https://www.benefitscanada.com/archives_/benefits-canada-archive/2023-drug-plan-trends-report-how-the-repercussions-of-the-pandemic-are-trickling-down-to-drug-plans/
7.SMART & BIGGAR. Biosimilars approved in Canada. [accessed 2024 Jul 7]. https://www.smartbiggar.ca/insights/biosimilars
8.Cardinal Health. 2024 Biosimilars Report – Insights on a pivotal year of evolution and expansion [accessed 2024 Jul 30]. https://www.cardinalhealth.com/content/dam/corp/web/documents/Report/cardinal-health-2024-Biosimilars-Report.pdf
9.Express Scripts Canada. 2024 Express Scripts Canada Drug Trend Report.. https://www.express-scripts.ca/sites/default/files/2024-05/2024_ESC_DTR_EN.pdf
10.IQVIA Institute for Human Data Science. Global Trends in R&D 2024: Activity, Productivity, and Enablers. [accessed Jun 2022]. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/global-trends-in-r-and-d-2024-activity-productivity-and-enablers/iqvia-institute-randd-trends-2024-02-24-forweb.pdf
11.Telus Health. 2023 Category watch: A closer look at disruption. https://resources.telushealth.com/en-ca/2023-category-watch-a-closer-look-at-disruption 2023.
12.Telus Health. Drug Data Trends & National Benchmarks. https://go.telushealth.com/hubfs/telus-health-drug-trends-report-2024-en.pdf?hsLang=en-ca.
13.Telus Health. Drug Pipeline: What private plans need to know. https://go.telushealth.com/hubfs/drug-pipeline-2024-what-private-plans-need-to-know.pdf?hsLang=en-ca#:~:text=In%20its%202024%20Drug%20Pipeline,weight%20loss%20and%20atopic%20dermatitis. 2024.
14.Government of Canada. Drug and Health Product Submissions Under Review (SUR). [accessed 2024 Jun 30]. https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review.html
15.US Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs [ accessed 2024 Jun 30]. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
16.Vannabouathong C, Crotty C, Le K, Eurich D, Dyrda P. 2022. Current Utilization Patterns of Glucagon-Like Peptide-1 Receptor Agonists. Can J Health Technol. 2(9). [accessed 2024 Aug 03]. doi:10.51731/cjht.2022.434 PubMed
17.Ontario Government. Biosimilars. [accessed 2024 Aug 18]. https://www.ontario.ca/page/biosimilars
18.Tomalin A, Siu EC, Wyatt G, West K, Anderson S. An ever-evolving landscape: an update on the rapidly changing regulation and reimbursement of biosimilars in Canada. GaBI Journal. 2019 [accessed 2024 Aug 5];8(3):107–118. doi:10.5639/GABIJ.2019.0803.014
19.Ontario Government. Ontario Public Drug Programs Ministry of Health and Long-Term Care. 2017.
20.Memedovich KA, Manns B, Beall R, Hollis A, Clement F. The impact of pharmaceutical rebates on patients’ drug purchases. CMAJ. 2019 [accessed 2024 Jul 5];191(11):E308–E312. https://www.cmaj.ca/content/191/11/E308. doi:10.1503/cmaj.181041/-/DC1 PubMed
21.Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022 Jul 21;387(3):205-16. PubMed
22.Frías JP, Davies MJ, Rosenstock J, Pérez Manghi FC, Fernández Landó L, Bergman BK, Liu B, Cui X, Brown K. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021 Aug 5;385(6):503-15. PubMed
23.Tadrous M, Shakeri A, Hayes KN, Neville HL, Houlihan J, Clement F, Guertin JR, Law MR, Gomes T. Canadian trends and projections in prescription drug purchases: 2001-2023. Can J Health Technol. 2021 Nov 25;1(11) https://canjhealthtechnol.ca/index.php/cjht/article/view/mt0001
24.Aitken M, Berndt ER, Cutler D, Kleinrock M, Maini L. Has the era of slow growth for prescription drug spending ended? Health Affairs. 2016 Sep 1;35(9):1595.603.
25.Tichy EM, Hoffman JM, Tadrous M, Rim MH, Suda KJ, Cuellar S, Clark JS, Newell MK, Schumock GT. National trends in prescription drug expenditures and projections for 2023. Am J Health Syst Pharm. 2023 Jul 15;80(14)899-913. PubMed
26.Tichy EM, Hoffman JM, Suda KJ, Rim MH, Tadrous M, Cuellar S, Clark JS, Ward J, Schumock GT. National trends in prescription drug expenditures and projections for 2022. Am J Health Syst Pharm. 2022 Jul 15;79(14)1158-72. PubMed
Appendix 1: Author Information
Mina Tadrous, PharmD, PhD;1-3 Kevin Z Wang, MSc;2 Shanzeh Chaudhry, MSc;2 Cherry Chu, MSc;1 Fiona Clement, PhD;4,5 Jason R. Guertin, PhD;6,7 Michael R. Law, PhD;8 Wade Thompson, PharmD, PhD, MSc;9 Tara Gomes, PhD;2,3,10 Kaleen N. Hayes, PharmD, PhD11
1 Women’s College Research Institute, Women’s College Hospital, Toronto, Ontario
2 Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario
3 Institute for Clinical Evaluative Sciences, Toronto, Ontario
4 Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta
5 O’Brien Institute for Public Health, University of Calgary, Calgary, Alberta
6 Axe Santé des populations et Pratiques optimales en santé, Centre de recherche du CHU de Québec-Université Laval, Québec
7 Department of Social and Preventive Medicine, Université Laval, Québec
8 Centre for Health Services and Policy Research, School of Population and Public Health, University of British Columbia, Vancouver, British Columbia
9 Department of Anesthesiology, Pharmacology and Therapeutics, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia
10 Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Toronto, Ontario
11 Department of Health Services, Policy, and Practice, School of Public Health, Brown University, Providence, Rhode Island, US
Author Disclosures
Dr. Gomes receives salary support through a Canada Research Chair in Drug Policy and Substance Use and grant or contract funding from the Ontario Ministry of Health, Ontario College of Pharmacists, and Canada’s Drug Agency for unrelated work. Dr. Gomes has also received consulting fees and honorariums from Indigenous Services Canada and the Province of British Columbia for unrelated work. Dr. Law received salary support through a Canada Research Chair in Access to Medicines. Dr. Law has consulted for Health Canada and Canada’s Drug Agency and has provided expert witness testimony for the Attorney General of Canada, the Federation of Post-Secondary Educators, and the Durham Police Association. Dr. Guertin holds a research career award from the Fonds de recherche du Québec – Santé (FRQS). Dr. Guertin has consulted for the Institut national d’excellence en santé et en services sociaux (INESSS). Dr. Tadrous has consulted for Canada’s Drug Agency and Green Shield Canada. Dr. Tadrous reports consulting fees from Canada’s Drug Agency and Green Shield Canada and funding from the Ontario Ministry of Health. Dr. Hayes has received investigator-initiated grant funding paid directly to Brown University for investigator-initiated research from Sanofi, Genentech, and GlaxoSmithKline for research on influenza vaccination in nursing homes, influenza outbreak control, and shingles vaccination in nursing homes, respectively. Dr. Hayes also reports consulting fees from Canada’s Drug Agency. Dr. Thompson is supported by a salary award from Michael Smith Health Research BC and has received grants from the US Deprescribing Network and Health Canada. He has received an honorarium from Pharmacy Practice Plus magazine.
Acknowledgements
All authors were involved in the design, interpretation of results, writing, conceptualization of recommendations, and revision of the manuscript. MT was involved in the implementation of the study and had full access to all data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. MT is the guarantor of the content of the manuscript, including the data and analysis.
The statements, findings, conclusions, views, and opinions contained and expressed in the report are based in part on data obtained under license from IQVIA, Canada Inc. concerning the following information service(s): IQVIA’s Canadian Drugstore and Hospital Purchases Audit, data period January 1, 2001, to December 31, 2023. All rights reserved. The statements, findings, conclusions, views, and opinions expressed herein are not necessarily those of IQVIA Canada Inc. or any of its affiliated or subsidiary entities.
Corresponding Author
Mina Tadrous
Leslie Dan Faculty of Pharmacy, University of Toronto
144 College St., Toronto, Ontario
Mina.tadrous@utoronto.ca
Appendix 2: Additional Figures and Tables
Note that this appendix has not been copy edited.
Table 2: Selected Drugs and Biologics That Have Received Health Canada and/or FDA Approval in 2023 and Early 2024 and Are Expected to Impact Drug Spending in the Near Future
Category | Drug | Brand name or reference product | Indication | Health Canada approval date | FDA approved |
|---|---|---|---|---|---|
Oncology | Capivasertib | Truqap | Human epidermal growth factor 2 (HER2)-negative, hormone receptor (HR)-positive locally advanced or metastatic breast cancer | Jan 2024 | Nov 2023 |
Abemaciclib | Verzenio | Advanced and metastatic breast cancer, but was expanded for use in early breast cancer | Jan 2022 | Mar 2023 | |
V940/mRNA-4157 | — | High-risk melanoma | Phase III trial | No | |
Autogene cevumeran | — | A personalized vaccine for pancreatic ductal adrenal cancer | Phase II trial | No | |
TG4050 | — | Ovarian cancer and HPV-negative head and neck cancer | Phase I trial | No | |
Tedopi | — | Advanced non–small cell lung cancer | Phase II trial | No | |
VB10.16 | — | Advanced cervical cancer | Phase II trial | No | |
Atopic dermatitis | Dupilumab | Dupixent | Atopic dermatitis and severe asthma | Nov 2017 | Jan 2024 |
Neuromuscular | Trofinetide | Daybue | Rett syndrome | Oct 2024 | Mar 2023 |
Zilucoplan | Zilbrysq | Myasthenia gravis | Jul 2024 | Oct 2023 | |
Eplontersen | Wainua | Hereditary transthyretin amyloidosis-associated polyneuropathy | Jun 2024 | Dec 2023 | |
Other | Metreleptin | Myalepta | Lipodystrophy | Aug 2024 | Feb 2014 |
Immune Disease | Pozelimab | Veopoz | CHAPLE disease | — | Aug 2023 |
Macular degeneration | Ranibizumab | Byooviz | Age-related macular degeneration, diabetic macular edema, diabetic retinopathy | Mar 2023 | Sep 2021 |
Diabetes | Tirzepatide | Mounjaro | Type 2 diabetes management | Nov 2023 | May 2022 |
Crohn disease | Risankizumab | Skyrizi | Crohn disease and psoriatic arthritis | Mar 2022 | Jun 2024 |
Upadacitinib | Rinvoq | Crohn disease and psoriatic arthritis | Jul 2023 | Jan 2022 | |
Immunosuppressants | Ustekinumab | Wezlana Jamteki | Inflammatory bowel disease, psoriasis, psoriatic arthritis | Under review | Oct 2023 No |
Iptacopan | Fabhalta | Paroxysmal nocturnal hemoglobinuria | Under review | Dec 2023 | |
Aflibercept | Yesfili Opuviz | Macular degeneration | Under review | May 2024 | |
Eculizumab | Bkemv | Rare blood disorder | Under review | May 2024 | |
Asthma and COPD | Mepolizumab | Nucala | Severe eosinophilic asthma | Feb 2023 | Nov 2015 |
Table 3: Global Reports Reviewed to Determine Trends for Drug Spending in Canada
Report | Link |
|---|---|
Advancing Health Through Innovation: New Drug Therapy Approvals 2023 | Advancing Health Through Innovation: New Drug Therapy Approvals 2023 (fda.gov) |
2023 Drug Plan Trends Report: How the repercussions of the pandemic are trickling down to drug plans | |
Biosimilars approved in Canada Mar 2024 | |
2024 Biosimilars Report: Insights on a pivotal year of evolution and expansion | |
2024 Prescription Drug Trend Report | Express Scripts Canada 2024 Drug Trend Report.pdf (express-scripts.ca) |
Global Trends in R&D 2024: Activity, productivity, and enablers | Global Trends in R&D 2024: Activity, productivity, and enablers - IQVIA |
2023 Category watch: A closer look at disruption. Trends in drug utilization for diabetes, ADHD and cystic fibrosis | https://resources.telushealth.com/en-ca/2023-category-watch-a-closer-look-at-disruption |
2024 TELUS Health Drug Data Trends and National Benchmarks | https://go.telushealth.com/hubfs/telus-health-drug-trends-report-2024-en.pdf?hsLang=en-ca |
2024 Drug Pipeline: What private plans need to know | https://go.telushealth.com/hubfs/drug-pipeline-2024-what-private-plans-need-to-know.pdf?hsLang=en-ca |
Table 4: Health Canada Drug Approvals Between January 1, 2023, and March 31, 2024
Generic name | Sponsor | Therapeutic area | Approval date | Submission outcome |
|---|---|---|---|---|
Abaloparatide | Endo Ventures Ltd | Calcium Homeostasis | January 2023 | Cancelled by sponsor |
Abiraterone Acetate, Niraparib | Janssen Inc | Endocrine Therapy | June 2023 | Issued NOC under the NOC/c Guidance |
Acalabrutinib | Astrazeneca Canada Inc | Antineoplastic Agents | February 2023 | Issued NOC |
Acetaminophen | B. Braun Melsungen Ag | Analgesics | February 2023 | Issued NOC |
Acetaminophen, Ibuprofen Sodium Dihydrate | Biosyent Pharma Inc | Analgesics | February 2024 | Issued NOC |
Alpha1-Proteinase Inhibitor (Human) | Grifols Therapeutics Llc | Antihemorrhagics | November 2023 | Issued NOC |
Amifampridine | Medunik Canada | Other Nervous System Drugs | January 2023 | Issued NOC |
Andexanet Alfa | Astrazeneca Canada Inc | All Other Therapeutic Products | June 2023 | Issued NOC under the NOC/c Guidance |
Andusomeran | Moderna Biopharma Canada Corporation | Vaccines | September 2023 | Issued NOC |
Avatrombopag Maleate | Swedish Orphan Biovitrum Ab (Publ) | Antihemorrhagics | November 2023 | Issued NOC |
Bamlanivimab | Eli Lilly Canada Inc | Immune Sera and Immunoglobulins | February 2023 | Cancelled by sponsor |
Bevacizumab | Celltrion Healthcare Co Ltd | Antineoplastic Agents | January 2023 | Issued NOC |
Brincidofovir | Emergent Biodefense Operations Lansing Llc | Antivirals for Systemic Use | December 2023 | Issued NOC |
Calaspargase Pegol | Servier Canada Inc | Antineoplastic Agents | November 2023 | Issued NOC |
Calcium Oxybate, Magnesium Oxybate, Potassium Oxybate, Sodium Oxybate | Jazz Pharmaceuticals Ireland Limited | Other Nervous System Drugs | May 2023 | Issued NOC |
Cangrelor Tetrasodium | Chiesi Farmaceutici S.P.A. | Antithrombotic Agents | January 2023 | Issued NOC |
Cannabidiol | Gw Research Limited | Antiepileptics | November 2023 | Issued NOC |
Capivasertib | Astrazeneca Canada Inc | Antineoplastic Agents | January 2024 | Issued NOC |
Captopril | Ethypharm Inc | Agents Acting on the Renin-Angiotensin System | December 2023 | Issued NOC |
Cefditoren Pivoxil | Orimed Pharma Inc | Antibacterials for Systemic Use | March 2024 | Cancelled by sponsor |
Cenobamate | Endo Ventures Ltd | Antiepileptics | June 2023 | Issued NOC |
Ciltacabtagene Autoleucel | Janssen Inc | Antineoplastic Agents | February 2023 | Issued NOC under the NOC/c Guidance |
Clascoterone | Sun Pharmaceutical Industries Limited | Anti-Acne Preparations | June 2023 | Issued NOC |
Concizumab | Novo Nordisk Canada Inc | Antihemorrhagics | March 2023 | Issued NOC |
Concizumab | Novo Nordisk Canada Inc | Antihemorrhagics | July 2023 | Issued NOC |
Copper, Manganese Sulfate, Selenious Acid, Sodium Iodide, Zinc Sulfate | Sandoz Canada Incorporated | Blood Substitutes and Perfusion Solutions | March 2023 | Issued NOC |
Daprodustat | GlaxoSmithKline Inc | Antianemic Preparations | July 2023 | Cancelled by sponsor |
Daridorexant Hydrochloride | Idorsia Pharmaceuticals Ltd | Other Nervous System Drugs | April 2023 | Issued NOC |
Denosumab | Sandoz Canada Incorporated | Drugs For Treatment of Bone Diseases | February 2024 | Issued NOC |
Denosumab | Sandoz Canada Incorporated | Drugs For Treatment of Bone Diseases | March 2024 | Issued NOC |
Dexamethasone, Levofloxacin | Xediton Pharmaceuticals Inc | Ophthalmologicals | December 2023 | Issued NOC |
Diroximel Fumarate | Biogen Canada Inc | Immunosuppressants | February 2023 | Cancelled by sponsor |
Dronabinol | Tetra Bio-Pharma Inc | Antiemetics and Antinauseants | May 2023 | Cancelled by sponsor |
Efgartigimod Alfa | Argenx Bv | Immunosuppressants | September 2023 | Issued NOC |
Elranatamab | Pfizer Canada Ulc | Antineoplastic Agents | December 2023 | Issued NOC under the NOC/c Guidance |
Enoxaparin Sodium | Baxter Corporation | Antithrombotic Agents | July 2023 | Issued NOC |
Enterococcus faecalis Inactivated, Escherichia coli Inactivated, Klebsiella pneumoniae Inactivated, Proteus Vulgaris Inactivated | Red Leaf Medical Inc | Vaccines | May 2023 | Cancelled by sponsor |
Epcoritamab | Abbvie Corporation | Antineoplastic Agents | October 2023 | Issued NOC under the NOC/c Guidance |
Erwinia L-Asparaginase | Porton Biopharma Limited | Antineoplastic Agents | July 2023 | Cancelled by sponsor |
Estradiol, Norethindrone Acetate, Relugolix | Myovant Sciences Gmbh | Pituitary and Hypothalamic Hormones and Analogues | September 2023 | Issued NOC |
Estradiol, Norethindrone Acetate, Relugolix | Myovant Sciences Gmbh | Pituitary and Hypothalamic Hormones and Analogues | October 2023 | Issued NOC |
Etesevimab | Eli Lilly Canada Inc | Immune Sera and Immunoglobulins | February 2023 | Cancelled by sponsor |
Etranacogene Dezaparvovec | Csl Behring Canada Inc | Other Hematological Agents | October 2023 | Issued NOC |
Etrasimod L-Arginine | Pfizer Canada Ulc | Antidiarrheals, Intestinal Anti-Inflammatory/Anti-Infective Agents | January 2024 | Issued NOC |
Evinacumab | Ultragenyx Pharmaceutical Inc | Lipid Modifying Agents | September 2023 | Issued NOC |
Ferric Carboxymaltose | Vifor (International) Inc | Anti-anemic Preparations | March 2024 | Issued NOC |
Ferumoxytol | Covis Pharma Gmbh | Anti-anemic Preparations | February 2023 | Cancelled by sponsor |
Fidanacogene Elaparvovec | Pfizer Canada Ulc | Antihemorrhagics | December 2023 | Issued NOC |
Foscarbidopa, Foslevodopa | Abbvie Corporation | Anti-Parkinson Drugs | May 2023 | Issued NOC |
Gallium (68ga) Gozetotide | Advanced Accelerator Applications Usa, Inc | Diagnostic Radiopharmaceuticals | April 2023 | Issued NOC |
Glofitamab | Hoffmann-La Roche Limited | Antineoplastic Agents | March 2023 | Issued NOC under the NOC/c Guidance |
Inebilizumab | Horizon Therapeutics Ireland Dac | Immunosuppressants | December 2023 | Issued NOC |
Influenza Virus Type A (H1n1) | Sanofi Pasteur Limited | Vaccines | October 2023 | Issued NOC |
Insulin Icodec | Novo Nordisk Canada Inc | Drugs Used in Diabetes | March 2024 | Issued NOC |
Isotretinoin | Sun Pharmaceutical Industries Limited | Anti-Acne Preparations | June 2023 | Issued NOC |
Landiolol Hydrochloride | Trimedic Therapeutics Inc. | Beta Blocking Agents | November 2023 | Issued NOC |
Maralixibat Chloride | Mirum Pharmaceuticals, Inc. | Bile and Liver Therapy | July 2023 | Issued NOC |
Masitinib Mesylate | Ab Science S.A. | Antineoplastic Agents | February 2024 | Issued Notice of Deficiency - Withdrawal |
Meropenem Trihydrate | B.Braun Medical Inc | Antibacterials for Systemic Use | January 2024 | Issued NOC |
Metformin Hydrochloride | Pharmaris Canada Inc | Drugs Used in Diabetes | January 2023 | Issued NOC |
Methotrexate | Nordic Group B.V. | Immunosuppressants | March 2024 | Issued NOC |
Methylphenidate Hydrochloride | Kye Pharmaceuticals Inc | Psychoanaleptics | September 2023 | Issued NOC |
Metreleptin | Amryt Pharmaceuticals Dac | Other Alimentary Tract and Metabolism Products | January 2024 | Issued NOC |
Mirikizumab | Eli Lilly Canada Inc | Immunosuppressants | July 2023 | Issued NOC |
Molnupiravir | Merck Canada Inc | Antivirals for Systemic Use | April 2023 | Cancelled by sponsor |
Nirsevimab | Astrazeneca Canada Inc | Immune Sera and Immunoglobulins | April 2023 | Issued NOC |
Nivolumab, Relatlimab | Bristol-Myers Squibb Canada | Antineoplastic Agents | September 2023 | Issued NOC |
Odevixibat | Medison Pharma Canada Inc | Bile and Liver Therapy | October 2023 | Issued NOC |
Olipudase Alfa | Sanofi-Aventis Canada Inc | Other Alimentary Tract and Metabolism Products | February 2024 | Issued NOC |
Ranibizumab | Teva Canada Limited | Ophthalmologicals | October 2023 | Issued NOC |
Raxtozinameran | Biontech Manufacturing Gmbh | Vaccines | September 2023 | Issued NOC |
Relabotulinumtoxina | Galderma Sa | Muscle Relaxants | January 2024 | Cancelled by sponsor |
Relugolix | Sumitomo Pharma Switzerland Gmbh | Endocrine Therapy | October 2023 | Issued NOC |
Respiratory Syncytial Virus Prefusion F Protein (Rsvpref3) | GlaxoSmithKline Inc | Vaccines | August 2023 | Issued NOC |
Rimegepant | Pfizer Canada Ulc | Analgesics | December 2023 | Issued NOC |
Risperidone | Laboratorios Farmaceuticos Rovi, S.A. | Psycholeptics | March 2024 | Issued NOC |
Ritlecitinib | Pfizer Canada Ulc | Immunosuppressants | November 2023 | Issued NOC |
Roflumilast | Arcutis Biotherapeutics Inc | Other Dermatological Preparations | April 2023 | Issued NOC |
Rsv F Antigen 847a, Recombinant, Rsv F Antigen 847b, Recombinant | Pfizer Canada Ulc | Vaccines | December 2023 | Issued NOC |
Sabizabulin | Veru Inc | Antivirals for Systemic Use | June 2023 | Cancelled by sponsor |
Sars-Cov-2 Prefusion Spike Delta Tm Protein, Recombinant | Sanofi Pasteur Limited | Vaccines | February 2023 | Cancelled by sponsor |
Sars-Cov-2 Prefusion Spike Delta Tm Protein, Recombinant | Sanofi Pasteur Limited | Vaccines | February 2023 | Cancelled by sponsor |
Sars-Cov-2 Recombinant Spike Protein (Omicron Xbb.1.5) | Novavax Inc | Vaccines | December 2023 | Issued NOC |
Setmelanotide Acetate | Rhythm Pharmaceuticals Inc | Antiobesity Preparations, Excluding Diet Products | May 2023 | Issued NOC |
Smallpox Vaccine Dried | Emergent Product Development Gaithersburg Inc | Vaccines | December 2023 | Issued NOC |
Somapacitan | Novo Nordisk Canada Inc | Pituitary and Hypothalamic Hormones and Analogues | July 2023 | Issued NOC |
Spesolimab | Boehringer Ingelheim Canada Ltd Ltee | Immunosuppressants | March 2023 | Issued NOC |
Teclistamab | Janssen Inc | Antineoplastic Agents | July 2023 | Issued NOC under the NOC/c Guidance |
Tirbanibulin | Avir Pharma Inc | Antibiotics and Chemotherapy for Dermatological Use | May 2023 | Issued NOC |
Trastuzumab | Prestige Biopharma Ltd | Antineoplastic Agents | June 2023 | Cancelled by sponsor |
Tremelimumab | Astrazeneca Canada Inc | Antineoplastic Agents | August 2023 | Issued NOC |
Ustekinumab | Jamp Pharma Corporation | Immunosuppressants | November 2023 | Issued NOC |
Ustekinumab | Amgen Canada Inc | Immunosuppressants | December 2023 | Issued NOC |
Vericiguat | Bayer Inc | Cardiac Therapy | April 2023 | Issued NOC |
Vibrio Cholerae, Strain Cvd 103-Hgr, Live | Emergent Travel Health Inc | Vaccines | May 2023 | Issued NOC |
Vutrisiran | Alnylam Netherlands B.V. | Other Nervous System Drugs | October 2023 | Issued NOC |
NOC = Notice of Compliance, NOC/c = Notice of Compliance with conditions
Table 5: FDA Drug Approvals Between January 1, 2023, and March 31, 2024
Generic name | Brand name | Indication | Sponsor | Approval date |
|---|---|---|---|---|
Abacavir Sulfate; Lamivudine | Abacavir Sulfate and Lamivudine | HIV-1 | Mylan Pharmaceuticals, Inc. | December 22, 2023 |
Abacavir; Dolutegravir; Lamivudine | Abacavir; Dolutegravir; Lamivudine | HIV-1 | Aurobindo Pharma US, Inc. | August 14, 2023 |
Abacavir; Dolutegravir; Lamivudine | Abacavir; Dolutegravir; Lamivudine | HIV-1 | Mylan Pharmaceuticals, Inc. | August 16, 2023 |
Abiraterone Acetate; Niraparib Tosylate | Akeega | BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) | Janssen Biotech, Inc. | August 11, 2023 |
Acetaminophen; Ibuprofen | Combogesic | Acute pain | AFT Pharmaceuticals, Inc. | March 1, 2023 |
Acetaminophen; Ibuprofen Sodium | Combogesic IV | Acute pain | AFT Pharmaceuticals Ltd. | October 17, 2023 |
Acetylcysteine Lysine | Legubeti | Antidote to prevent or lessen hepatic injury following ingestion of hepatotoxic quantities of acetaminophen | Galephar Pharmaceutical Research, Inc. | February 13, 2024 |
Adalimumab-aaty | Yuflyma | Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, Hiradenitis suppurativa | Celltrion, Inc. | May 23, 2023 |
Adalimumab-ryvk | Simlandi | Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, uveitis | Alvotech USA, Inc. | February 23, 2024 |
Adapalene; Benzoyl Peroxide; Clindamycin Phosphate | Cabtreo | Acne vulgaris | Bausch Health US, LLC | October 20, 2023 |
Aflibercept | Eylea HD | Neovascular age-related macular degeneration, diabetic macular edema, diabetic retinopathy | Regeneron Pharmaceuticals, Inc. | August 18, 2023 |
Albuterol Sulfate; Budesonide | Airsupra | Asthma | Bond Avillion 2 Development LP | January 10, 2023 |
Aprocitentan | Tryvio | Hypertension | Idorsia Pharmaceuticals Ltd. | March 19, 2024 |
Aripiprazole | Abilify Asimtufii | Schizophrenia, Bipolar I Disorder | Otsuka Pharmaceutical Company, Ltd. | April 27, 2023 |
Atorvastatin Calcium | Atorvaliq | Hyperlipidemia, hypercholesterolemia | CMP Development LLC | February 1, 2023 |
Avacincaptad Pegol Sodium | Izervay | Geographic atrophy secondary to age-related macular degeneration | IVERIC bio, Inc. | August 4, 2023 |
Berdazimer Sodium | Zelsuvmi | Molluscum contagiosum | LNHC, Inc. | January 5, 2024 |
Bevacizumab-tnjn | Avzivi | Metastatic colorectal cancer | Bio-Thera Solutions Ltd. | December 6, 2023 |
Bexagliflozin | Brenzavvy | Type 2 diabetes mellitus | TheracosBio, LLC | January 20, 2023 |
Bimekizumab-bkzx | Bimzelx | Plaque psoriasis | UCB, Inc. | October 17, 2023 |
Birch Triterpenes | Filsuvez | Wounds associated with dystrophic and junctional epidermolysis bullosa | Amryt Pharmaceuticals DAC | December 18, 2023 |
Bosutinib Monohydrate | Bosulif | Philadelphia chromosome-positive chronic myelogenous leukemia | PF Prism C.V. | September 26, 2023 |
Budesonide | Eohilia | Eosinophilic esophagitis | Takeda Pharmaceuticals USA, Inc. | February 9, 2024 |
Budesonide; Formoterol Fumarate | Symbicort Aerosphere | Chronic obstructive pulmonary disease (COPD) | AstraZeneca Pharmaceuticals LP | April 28, 2023 |
Buprenorphine | Brixadi | Opioid use disorder | Braeburn Inc. | May 23, 2023 |
Cabazitaxel | Cabazitaxel | Metastatic castration-resistant prostate cancer | Sandoz, Inc. | October 27, 2023 |
Cabazitaxel | Cabazitaxel | Metastatic castration-resistant prostate cancer | Actavis LLC | March 14, 2024 |
Cantharidin | Ycanth | Molluscum contagiosum | Verrica Pharmaceuticals, Inc. | July 21, 2023 |
Capivasertib | Truqap | HR-positive, HER2-negative locally advanced or metastatic breast cancer | AstraZeneca Pharmaceuticals LP | November 16, 2023 |
Carbon Dioxide | Carbon Dioxide | Insufflation gas during laparoscopic surgery | Haun Specialty Gases, Inc. | February 17, 2024 |
Cefazolin Sodium | Cefazolin Sodium | Perioperative prophylaxis | HQ Speciality Pharma Corp. | May 8, 2023 |
Cefepime Hydrochloride; Enmetazobactam | Exblifep | Complicated urinary tract infections | Allecra Therapeutics SAS | February 22, 2024 |
Cipaglucosidase alfa-atga | Pombilitibla | Pompe disease | Amicus Therapeutics US, LLC | September 28, 2023 |
Clobetasol Propionate | Clobetasol Propionate | Post-operative inflammation and pain following ocular surgery | Formosa Pharmaceuticals, Inc. | March 4, 2024 |
Colchicine | Lodoco | Reduce risk of myocardial infarction, stroke, coronary revascularization, and cardiovascular death associated with established atherosclerotic disease | Agepha Pharma FZ LLC | June 16, 2023 |
Crizotinib | Xalkori | Metastatic non–small cell lung cancer (NSCLC), systemic anaplastic large cell lymphoma (ALCL), inflammatory myofibroblastic tumour (IMT) | PF Prism C.V. | September 7, 2023 |
Cyclophosphamide | Cyclophosphamide | Malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma | Dr. Reddy’s Laboratories Inc. | June 7, 2023 |
Cyclophosphamide | Cyclophosphamide | Malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma | Nevakar Injectables, Inc. | June 27, 2023 |
Cyclophosphamide | Cyclophosphamide | Malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma | Sandoz, Inc. | September 12, 2023 |
Cyclosporine | Vevye | Dry eye disease | Novaliq GmbH | May 30, 2023 |
Dabrafenib Mesylate | Tafinlar | Low-grade glioma with BRAF V600E mutation | Novartis Pharmaceuticals Corp. | March 16, 2023 |
Danicopan | Voydeya | Extravascular hemolysis associated with paroxysmal nocturnal hemoglobinuria | Alexion Pharmaceuticals, Inc. | March 29, 2024 |
Daprodustat | Jesduvroq | Anemia due to chronic kidney disease | GlaxoSmithKline LLC | February 1, 2023 |
Daptomycin | Daptomycin | Antibiotic (multiple indications) | Xellia Pharmaceuticals ApS | January 30, 2023 |
Darunavir and Ritonavir | Darunavir and Ritonavir | HIV-1 | Mylan Pharmaceuticals, Inc. | December 22, 2023 |
Dasatinib | Phyrago | Philadelphia chromosome-positive chronic myeloid leukemia | Nanocopoeia LLC | December 5, 2023 |
Denosumab-bbdz | Jubbonti | Osteoporosis | Sandoz, Inc. | March 5, 2024 |
Denosumab-bbdz | Wyost | Osteoporosis | Sandoz, Inc. | March 5, 2024 |
Deutetrabenazine | Austedo XR | Huntington’s disease and tardive dyskinesia | Teva Neuroscience, Inc. | February 17, 2023 |
Dolutegravir | Dolutegravir | HIV-1 | Laurus Generics, Inc. | April 28, 2023 |
Dolutegravir, Emtricitabine, Tenofovir Alafenamide | Dolutegravir, Emtricitabine, Tenofovir Alafenamide | HIV-1 | Aurobindo Pharma USA, Inc. | May 26, 2023 |
Dolutegravir; Lamivudine; Tenofovir Disoproxil Fumarate | Dolutegravir; Lamivudine; Tenofovir Disoproxil Fumarate | HIV-1 | Emcure Pharmaceuticals Ltd | July 12, 2023 |
Dolutegravir; Tenofovir Disoproxil Fumarate; Lamivudine | Dolutegravir; Tenofovir Disoproxil Fumarate; Lamivudine | HIV-1 | Strides Pharma, Inc. | September 14, 2023 |
Dolutegravir; Emtricitabine; Tenofovir Alafenamide | Dolutegravir; Emtricitabine; Tenofovir Alafenamide | HIV-1 | Lupin Pharmaceuticals, Inc. | January 19, 2023 |
Dolutegravir; Emtricitabine; Tenofovir Alafenamide | Dolutegravir; Emtricitabine; Tenofovir Alafenamide | HIV-1 | Laurus Generics, Inc. | October 12, 2023 |
Dolutegravir; Emtricitabine; Tenofovir Alafenamide | Dolutegravir; Emtricitabine; Tenofovir Alafenamide | HIV-1 | Hetero Labs Limited, Unit-III, India | January 18, 2024 |
Dolutegravir; Lamivudine; Tenofovir Alafenamide | Dolutegravir; Lamivudine; Tenofovir Alafenamide | HIV-1 | Lupin Pharmaceuticals, Inc. | July 18, 2023 |
Durlobactam Sodium; Sulbactam Sodium | Xacduro | Hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP) | Entasis Therapeutics, Inc. | May 23, 2023 |
Efavirenz, Emtricitabine, Tenofovir Alafenamide | Efavirenz, Emtricitabine, Tenofovir Alafenamide | HIV-1 | Mylan Pharmaceuticals, Inc. | March 22, 2024 |
Efbemalenograstim alfa-vuxw | Ryzneuta | Decrease incidence of infection as manifested by febrile neutropenia | Evive Biotechnology Singapore PTE Ltd. | November 16, 2023 |
Efgartigimod alfa and Hyaluronidase-qvfc | Vyvgart Hytrulo | Generalized myasthenia gravis (gMG) | Argenx BV | June 20, 2023 |
Eflornithine Hydrochloride | Iwilfin | Reduce risk of relapse of high-risk neuroblastoma | USWM, LLC | December 13, 2023 |
Elacestrant Dihydrochloride | Orserdu | ER-positive, HER-2 negative, or ESR-1 mutated advanced, or metastatic breast cancer | Stemline Therapeutics, Inc. | January 27, 2023 |
Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor | Trikafta | Cystic fibrosis (CF) with at least 1 F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive | Vertex Pharmaceuticals Inc. | April 26, 2023 |
Elranatamab | Elrexfio | Relapsed or refractory multiple myeloma | Pfizer, Inc. | August 14, 2023 |
Eltrombopag Choline | Alvaiz | Thrombocytopenia, severe aplastic anemia | Teva Pharmaceuticals, Inc. | November 29, 2023 |
Entrectinib | Rozlytrek | Solid tumours with neurotrophic tyrosine receptor kinase (NTRK) gene fusion | Genentech, Inc. | October 20, 2023 |
Epcoritamab-bysp | Epkinly | Relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) | Genmab US, Inc. | May 19, 2023 |
Epinephrine | Adrenalin | Hypotension associated with septic shock | Par Sterile Products, LLC | April 21, 2023 |
Eplontersen Sodium | Wainua (Autoinjector) | Polyneuropathy of hereditary transthyretin-mediated amyloidosis | Ionis Pharmaceuticals, Inc. | December 21, 2023 |
Etrasimod Arginine | Velsipity | Ulcerative colitis | Pfizer, Inc. | October 12, 2023 |
Fentanyl Citrate | Fentanyl Citrate | Opioid analgesic supplement in general anesthesia | Exela Pharma Sciences, LLC | February 8, 2023 |
Fezolinetant | Veozah | Vasomotor symptoms due to menopause | Astellas Pharma US, Inc. | May 12, 2023 |
Flotufolastat F 18 Gallium | Posluma | Diagnostic aid in PET of prostate-specific membrane antigen (PSMA) positive lesions in prostate cancer | Blue Earth Diagnostics Ltd. | May 25, 2023 |
Fosaprepitant Dimeglumine | Focinvez | Prevention of acute and delayed nausea and vomiting associated with cancer chemotherapy | Spes Pharmaceuticals, Inc. | August 22, 2023 |
Fruquintinib | Fruzaqla | Metastatic colorectal cancer | Takeda Pharmaceuticals USA, Inc. | November 8, 2023 |
Gepirone Hydrochloride | Exxua | Major depressive disorder | Fabre-Kramer Pharmaceuticals, Inc. | September 22, 2023 |
Givinostat Hydrochloride | Duvyzat | Duchenne muscular dystrophy | Italfarmaco S.p.A. | March 21, 2024 |
Glofitamab-gxbm | Columvi | Relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL, NOS), large B-cell lymphoma (LBCL) arising from follicular lymphoma | Genentech, Inc. | June 15, 2023 |
Glycopyrrolate; Neostigmine Methylsulfate | Prevduo | Reversal of effects of non-depolarizing neuromuscular blocking agents after surgery | Slayback Pharma LLC | February 23, 2023 |
Heparin Sodium; Taurolidine | Defencath | Prevention of catheter-related bloodstream infections in kidney failure | CorMedix, Inc. | November 15, 2023 |
Hyaluronidase Human Recombinant for Further Manufacturing Use | Hyaluronidase Human Recombinant for Further Manufacturing Use | Used for further manufacture of the final product Vyvgart Hytrulo | Halozyme Therapeutics, Inc. | June 20, 2023 |
Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Acute pain | Hikma Pharmaceuticals USA, Inc. | December 14, 2023 |
Iloprost | Aurlumyn | Severe frostbite to reduce risk of digit amputation | Eicos Sciences, Inc. | February 13, 2024 |
Infliximab-dyyb | Zymfentra | Ulcerative colitis, Crohn disease | Celltrion, Inc. | October 20, 2023 |
Iptacopan Hydrochloride | Fabhalta | Paroxysmal nocturnal hemoglobinuria | Novartis Pharmaceuticals Corp. | December 5, 2023 |
Lacosamide | Motpoly XR | Partial-onset seizures | Aucta Pharmaceuticals, Inc. | May 4, 2023 |
Lecanemab-irmb | Leqembi | Alzheimer disease | Eisai Inc. | January 6, 2023 |
Leniolisib Phosphate | Joenja | Activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) | Pharming Technologies B.V. | March 24, 2023 |
Letibotulinumtoxina-wlbg | Letybo | Temporary improvement in appearance of glabellar lines | Hugel, Inc. | February 29, 2024 |
Lotilaner | Xdemvy | Demodex blepharitis | Tarsus Pharmaceuticals, Inc. | July 24, 2023 |
Macitentan; Tadalafil | Opsynvi | Pulmonary arterial hypertension | Actelion Pharmaceuticals US, Inc. | March 22, 2024 |
Magnesium Sulfate; Polyethylene Glycol 3350; Potassium Chloride; Sodium Chloride; Sodium Sulfate | Suflave | Cleansing of the colon in preparation for colonoscopy | Braintree Laboratories, Inc. | June 15, 2023 |
Melphalan Hydrochloride | Hepzato | Uveal melanoma | Delcath Systems, Inc. | August 14, 2023 |
Melphalan Hydrochloride | Melphalan Hydrochloride | Multiple myeloma | Apotex, Inc. | August 18, 2023 |
Meropenem | Meropenem | Bacterial meningitis | HQ Speciality Pharma Corp. | July 26, 2023 |
Metformin Hydrochloride; Sitagliptin | Zituvimet | Type 2 diabetes mellitus | Zydus Worldwide DMCC | November 3, 2023 |
Metronidazole | Likmez | Trichomoniasis, amebiasis, anaerobic bacterial infections | Saptalis Pharmaceuticals LLC | September 22, 2023 |
Micafungin Sodium | Micafungin in Sodium Chloride 0.9% | Candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis | Baxter Healthcare Corp. | September 29, 2023 |
Miglustat | Opfolda | Pompe disease | Amicus Therapeutics US, LLC | September 28, 2023 |
Mirikizumab-mrkz | Omvoh | Ulcerative colitis | Eli Lilly and Company | October 26, 2023 |
Momelotinib Dihydrochloride | Ojjaara | Intermediate or high-risk myelofibrosis | GlaxoSmithKline LLC | September 15, 2023 |
Motixafortide Acetate | Aphexda | Preparation for autologous transplantation in multiple myeloma | BioLineRx Ltd. | September 8, 2023 |
Nalmefene Hydrochloride | Opvee | Opioid overdose | Opiant Pharmaceuticals, Inc. | May 22, 2023 |
Naloxone Hydrochloride | Rextovy | Opioid overdose | Amphastar Pharmaceuticals Inc. | March 7, 2023 |
Naloxone Hydrochloride | Rivive | Opioid overdose | Harm Reduction Therapeutics, Inc. | July 28, 2023 |
Natalizumab-sztn | Tyruko | Multiple sclerosis, Crohn disease | Sandoz, Inc. | August 24, 2023 |
Nedosiran Sodium | Rivfloza | Primary hyperoxaluria type 1 (PH1) | Novo Nordisk, Inc. | September 29, 2023 |
Niraparib Tosylate | Zejula | Advanced or germline BRCA-mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer | GlaxoSmithKline LLC | April 26, 2023 |
Nirmatrelvir; Ritonavir | Paxlovid | Coronavirus disease 2019 (COVID-19) | Pfizer, Inc. | May 25, 2023 |
Nirogacestat Hydrobromide | Ogsiveo | Desmoid tumours | SpringWorks Therapeutics, Inc. | November 27, 2023 |
Nirsevimab-alip | Beyfortus | Prevention of respiratory syncytial virus (RSV) | AstraZeneca AB | July 17, 2023 |
Omaveloxolone | Skyclarys | Friedreich’s ataxia | Reata Pharmaceuticals, Inc. | February 28, 2023 |
Oxaprozin | Coxanto | Osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis | Solubiomix, LLC | October 20, 2023 |
Paclitaxel | Paclitaxel | Advanced or metastatic breast, non–small cell lung, or adenocarcinoma of the pancreas cancers | Teva Pharmaceuticals, Inc. | May 11, 2023 |
Palovarotene | Sohonos | Reduction in volume of new heterotopic ossification associated with fibrodysplasia ossificans progressive | Ipsen Biopharmaceuticals, Inc. | August 16, 2023 |
Pantoprazole Sodium | Pantoprazole Sodium in 0.9% Sodium Chloride | Gastroesophageal reflux disease associated with erosive esophagitis, pathological hypersecretory conditions such as Zollinger-Ellison syndrome | Baxter Healthcare Corp. | February 14, 2024 |
Pegcetacoplan | Syfovre | Geographical atrophy secondary to age-related macular degeneration | Apellis Pharmaceuticals, Inc. | February 17, 2023 |
Pegunigalsidase alfa-iwxj | Elfabrio | Fabry disease | Chiesi Farmaceutici S.p.A. | May 9, 2023 |
Pemetrexed Disodium | Pemetrexed | Metastatic non-squamous non–small cell lung cancer (NSCLC), malignant pleural mesothelioma | Shilpa Medicare Limited | May 22, 2023 |
Perfluorohexyloctane | Miebo | Dry eye disease | Bausch & Lomb Inc. | May 18, 2023 |
Phentolamine Mesylate | Ryzumvi | Pharmacologically induced mydriasis | Ocuphire Pharma, Inc. | September 25, 2023 |
Phenylephrine Hydrochloride; Tropicamide | Mydcombi | Diagnostic aid to induce mydriasis | Eyenovia, Inc. | May 5, 2023 |
Pilocarpine Hydrochloride | Qlosi | Presbyopia | Orasis Pharmaceuticals, Ltd. | October 17, 2023 |
Pirtobrutinib | Jaypirca | Relapsed or refractory mantle cell lymphoma | Loxo Oncology, Inc. | January 27, 2023 |
Pozelimab-bbfg | Veopoz | CD55-deficient protein-losing enteropathy (CHAPLE disease) | Regeneron Pharmaceuticals, Inc. | August 18, 2023 |
Quizartinib Dihydrochloride | Vanflyta | Acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive | Daiichi Sankyo, Inc. | July 20, 2023 |
Repotrectinib | Augtyro | Locally advanced or metastatic ROS1-positive non–small cell lung cancer | Bristol-Myers Squibb Company | November 15, 2023 |
Resmetirom | Rezdiffra | Noncirrhotic non-alcoholic steatohepatitis | Madrigal Pharmaceuticals, Inc. | March 14, 2024 |
Retifanlimab-dlwr | Zynyz | Metastatic or recurrent locally advanced Merkel cell carcinoma | Incyte Corp. | March 22, 2023 |
Rezafungin Acetate | Rezzayo | Candidemia and invasive candidiasis | Cidara Therapeutics, Inc. | March 22, 2023 |
Rilpivirine Hydrochloride | Edurant Ped | HIV-1 | Janssen Products LP | March 15, 2024 |
Risperidone | Risvan | Schizophrenia | Laboratorios Farmacéuticos ROVI, S.A. | March 29, 2024 |
Risperidone | Rykindo | Schizophrenia, Bipolar I Disorder | Shandong Luye Pharmaceutical Co., Ltd. | January 13, 2023 |
Risperidone | Uzedy | Schizophrenia | Teva Neuroscience | April 28, 2023 |
Ritlecitinib Tosylate | Litfulo | Alopecia areata | Pfizer, Inc. | June 23, 2023 |
Rizatriptan Benzoate | Rizafilm | Migraines, with or without aura | IntelGenx Corp. | April 14, 2023 |
Roflumilast | Zoryve | Seborrheic dermatitis | Arcutis Biotherapeutics, Inc. | December 15, 2023 |
Rozanolixizumab-noli | Rystiggo | Generalized myasthenia gravis (gMG) | UCB, Inc. | June 26, 2023 |
Secukinumab | Cosentyx | Active psoriatic arthritis, active ankylosing spondylitis, active non-radiographic axial spondylarthritis | Novartis Pharmaceutical Corp. | October 6, 2023 |
Sildenafil Citrate | Liqrev | Pulmonary arterial hypertension | CMP Development LLC | April 28, 2023 |
Sitagliptin | Zituvio | Type 2 diabetes mellitus | Zydus Worldwide DMCC | October 18, 2023 |
Sodium Oxybate | Lumryz | Cataplexy or excessive daytime sleepiness (EDS) associated with narcolepsy | Avadel CNS Pharmaceuticals, LLC | May 1, 2023 |
Somatrogon-ghla | Ngenla | Growth failure due to inadequate secretion of endogenous growth hormone | Pfizer Ireland Pharmaceuticals | June 27, 2023 |
Sotagliflozin | Inpefa | Prevention of heart failure and cardiovascular death associated with heart failure, type 2 diabetes, and chronic kidney disease | Lexicon Pharmaceuticals, Inc. | May 26, 2023 |
Sotatercept-csrk | Winrevair | Pulmonary arterial hypertension | Merck Sharp & Dohme LLC | March 26, 2024 |
Sparsentan | Filspari | Reduce proteinuria in primary immunoglobulin A nephropathy | Travere Therapeutics, Inc. | February 17, 2023 |
Talazoparib Tosylate | Talzenna | BRCA-mutated HER2-negative locally advanced or metastatic breast cancer | Pfizer, Inc. | March 7, 2024 |
Talquetamab-tgvs | Talvey | Relapsed or refractory multiple myeloma | Janssen Biotech, Inc. | August 9, 2023 |
Technetium Tc-99m Labelled Carbon | Technegas Kit | Diagnostic aid for visualization of pulmonary ventilation and evaluation of pulmonary embolism | Cyclomedica Australia Pty Ltd. | September 29, 2023 |
Technetium Tc-99m Mertiatide Injection Kit | Technetium Tc-99m Mertiatide Injection Kit | Diagnostic aid to assess renal function for whole kidney and renal cortex | Jubilant Draximage Inc. | January 30, 2023 |
Tenapanor Hydrochloride | Xphozah | Chronic kidney disease | Ardelyx, Inc. | October 17, 2023 |
Tirzepatide | Zepbound (Autoinjector) | Chronic weight management | Eli Lilly and Company | November 8, 2023 |
Tirzepatide | Zepbound | Chronic weight management | Eli Lilly and Company | November 8, 2023 |
Tislelizumab-jsgr | Tevimbra | Unresectable or metastatic esophageal squamous cell carcinoma | BeiGene USA, Inc. | March 13, 2024 |
Tocilizumab-aazg | Tyennebla | Rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis | Fresenius Kabi USA, LLC | March 5, 2024 |
Tocilizumab-bavi | Tofidence | Rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis | Biogen MA, Inc. | September 29, 2023 |
Tofersen | Qalsody | Amyotrophic lateral sclerosis (ALS) with mutation in the superoxide dismutase 1 (SOD1) gene | Biogen Inc. | April 25, 2023 |
Toripalimab-tpzi | Loqtorzi | Metastatic or recurrent locally advanced nasopharyngeal carcinoma | Coherus BioSciences, Inc. | October 27, 2023 |
Trametinib | Mekinist | Low-grade glioma with BRAF V600E mutation | Novartis Pharmaceuticals Corp. | March 16, 2023 |
Trametinib Dimethyl Sulfoxide | Mekinist | Low-grade glioma with BRAF V600E mutation | Novartis Pharmaceuticals Corp. | March 16, 2023 |
Travoprost | iDose TR | Reduction of elevated intraocular pressure in open-angle glaucoma or ocular hypertension | Glaukos Corp. | December 13, 2023 |
Trofinetide | Daybue | Rett syndrome | Acadia Pharmaceuticals, Inc. | March 10, 2023 |
Ustekinumab-auub | Wezlana | Plaque psoriasis, psoriatic arthritis, Crohn disease, ulcerative colitis | Amgen, Inc. | October 31, 2023 |
Ustekinumab-auub | Wezlana | Plaque psoriasis, psoriatic arthritis, Crohn disease, ulcerative colitis | Amgen, Inc. | October 31, 2023 |
Vadadustat | Vafseo | Anemia due to chronic kidney disease | Akebia Therapeutics, Inc. | March 27, 2024 |
Vamorolone | Agamree | Duchenne muscular dystrophy | Santhera Pharmaceuticals Ltd. | October 26, 2023 |
Vancomycin Hydrochloride | Vancomycin Hydrochloride | Antibiotic (multiple indications) | Zhejiang Novus Pharmaceuticals Co. Ltd. | January 20, 2023 |
Vasopressin | Vasopressin In Sodium Chloride 0.9% | Hypotension associated with vasodilatory shock | Baxter Healthcare Corp. | September 29, 2023 |
Vedolizumab | Entyvio | Ulcerative colitis | Takeda Pharmaceuticals US, Inc. | September 27, 2023 |
Velmanase alfa-tycv | Lamzede | Alpha-mannosidosis | Chiesi Farmaceutici SpA | February 16, 2023 |
Vonoprazan Fumarate | Voquezna | Erosive esophagitis, Helicobacter pylori (H. pylori) infection | Phathom Pharmaceuticals, Inc. | November 1, 2023 |
Vortioxetine | Sehippy | Major depressive disorder | Seasons Biotechnology (Taizhou) Co., Ltd | February 16, 2024 |
Zavegepant Hydrochloride | Zavzpret | Migraines, with or without aura | Pfizer Inc. | March 9, 2023 |
Zilucoplan Sodium | Zilbrysq | Generalized myasthenia gravis (gMG) | UCB, Inc. | October 17, 2023 |
Zolpidem Tartrate | Zolpidem Tartrate | Transient insomnia | Almatica Pharma, LLC | May 9, 2023 |
ISSN: 2563-6596
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