Generic drug approvals in 2025, by the numbers

On May 14, 2025, FDA added nine entries to its list of first generic approvals in a single day. All nine were for rivaroxaban tablets, a blood thinner, according to FDA's 2025 first generic drug approvals list⁷. Two rivaroxaban tablet entries had already appeared on March 3, and a rivaroxaban granule for oral suspension followed on June 26.

By December, rivaroxaban led GxRadar's count of the year's generic approvals with 19 original applications, based on FDA's public Drugs@FDA database⁸. Prucalopride, a drug for chronic constipation, was second with 14.

How many generics FDA approved in 2025 depends on who is counting and over which 12 months. The agency's fiscal-year report puts final approvals at 689, with another 250 tentative approvals. GxRadar's calendar-year count, built from the same agency's data, comes to 648 original approvals, the lowest since 2021. Both are built from FDA records, and the gap between them is mostly a matter of calendar.

The fiscal-year count

FDA's fiscal year starts Oct. 1, so fiscal 2025 ran from October 2024 through September 2025. The agency's fiscal 2025 activities report¹, last updated Nov. 24, 2025, lists 689 approvals, 250 tentative approvals, 92 first-time generics and 1,281 complete response letters, the letters FDA sends when an application cannot be approved as submitted. The same figures appear in FDA's GDUFA performance report to Congress for fiscal 2025⁵.

FDA's monthly reports for fiscal 2022⁴, 2023³ and 2024² give the earlier years.

Final approvals barely moved between 2024 and 2025. Tentative approvals rose by 88, or 54 percent. A tentative approval means FDA has found a generic ready for approval except that a patent or exclusivity on the brand still blocks it, and the generic cannot be sold until that clears. Complete response letters fell for the third year running.

Fewer applications came in. FDA recorded 600 original generic applications received in fiscal 2025, against 740 in fiscal 2024, according to the two monthly reports. At the end of September 2025, 1,327 applications were waiting on FDA. Another 1,891 were waiting on the applicant, 566 of them holding tentative approvals and 1,325 holding complete response letters.

In an April 2026 presentation⁶, FDA's Office of Generic Drugs combined the two approval types into one headline figure, 939 applications approved or tentatively approved in fiscal 2025. That total included 125 complex generics and 107 applications with a competitive generic therapy designation, the program for drugs with little or no generic competition.

The calendar-year count

GxRadar counts approvals differently. Each generic application in FDA's Drugs@FDA data⁸ is assigned to the calendar year in which its original submission was approved. Applications are counted once, whether or not the product is still sold. The series is not built the same way as FDA's fiscal reports, so the two should not be compared year for year.

At 648, 2025 came in 64 below 2024 and was the lowest since 2021. Monthly approvals ranged from 67 in June to 39 in September. The full series back to 1984 is on GxRadar's approvals page.

What got approved

GxRadar sorted the 648 calendar-2025 approvals by the route of administration listed for each product in Drugs@FDA⁸. An application counts as injectable if any of its products is given by injection or infusion.

In all, 2025's approvals covered 364 distinct active ingredients or combinations. After rivaroxaban and prucalopride came ticagrelor, another blood thinner, with eight, and the leukemia drug dasatinib with seven. Six molecules had six approvals each: potassium chloride, doxycycline hyclate, macitentan, tretinoin, deflazacort and selenious acid, an injectable source of the trace element selenium.

Same-day clusters are common when several applicants have been held back by the same patent or exclusivity date, and they explain how one molecule can fill a run of entries on the first generics list.

The first generics FDA singled out

FDA's fiscal 2025 report to Congress⁵ names five significant first generic approvals. They were liraglutide injection for chronic weight management and iron sucrose injection for iron deficiency anemia in chronic kidney disease, both in August 2025; an extended-release combination of sitagliptin and metformin in June; rivaroxaban in May; and siponimod, a multiple sclerosis drug, in April.

The report gives most space to a Dec. 23, 2024, approval, the first generic liraglutide referencing the brand used for type 2 diabetes. FDA called it "a significant milestone as the first generic product approved for a once-daily GLP-1 receptor agonist for type 2 diabetes." It credited research paid for by generic drug user fees, including nuclear magnetic resonance methods for comparing the peptide's structure, and said the same work supported the weight-management approval eight months later. Our explainers on complex generics and GDUFA user fees cover that background.

The calendar-year first generics list⁷ has 91 entries. It opens with a vitamin K injection on Jan. 3 and closes with sitagliptin tablets on Dec. 30, four weeks after the first generic sitagliptin and metformin tablets. Along the way it includes three iron sucrose entries on Aug. 8, a beclomethasone inhaler on Dec. 16 and a rectal diazepam gel in November. The list carries FDA's own warning that "approved drugs are not always available on or after the listed approval date." Our piece on what the yearly first generics lists show explains how entries are counted.

The guidance behind the applications

Most generic applicants build their studies around FDA's product-specific guidances. According to the fiscal 2025 report⁵, FDA issued 925 of them that year, 49 for complex products, bringing the published total to 2,288 as of Sept. 30, 2025. The same report counted six general guidances for industry on generic drugs during the year.

Filing also got cleaner. FDA refused to receive 18 original applications in fiscal 2025, down from 24 the year before, according to the monthly report¹, and the agency's April 2026 forum presentation⁶ included a slide on the reduction in such refusals.

Fiscal 2026 closed on Sept. 30, 2026. FDA posted its fiscal 2025 table in November 2025, and the fiscal 2026 figures will be the next entry in that series. In GxRadar's calendar count, 2026 stood at 575 original generic approvals through Oct. 27, with two months left in the year. How an application gets that far is laid out in How a generic drug gets approved.