Forty years of generic drug approvals, counted

FDA approved 207 original generic drug applications in calendar 1984, the year Congress created the modern generic pathway. Through Oct. 28, 2026, it had approved 579 this year alone. Between those two points sit 17,592 original approvals of abbreviated new drug applications, or ANDAs, by GxRadar's count of FDA's Drugs@FDA database as published through openFDA¹.

Growth came in fits. Approvals nearly doubled in the first three years after the law passed, collapsed at the end of the 1980s, took a decade to recover, and roughly doubled between 2013 and 2017, after Congress began funding generic review with user fees. The annual figure has stayed between 600 and 850 in every full year since 2016.

Generics now account for "more than 90 percent of prescriptions filled in the United States," according to FDA's Office of Generic Drugs⁶. What follows is the approval record behind that share, decade by decade, with the events FDA's own documents tie to the turns. The year-by-year chart is on GxRadar's approvals page.

How GxRadar counted

Each application is counted once, in the calendar year of its original approval, meaning the first final approval of the application itself. Later supplements, new strengths added to an existing application and tentative approvals are excluded. Drugs@FDA holds 19,597 ANDA records with an original approval date. About 2,000 carry dates before 1984 and are left out of the totals here, along with anything after Oct. 28, 2026.

Two cautions apply. FDA reports its own figures by fiscal year, which starts Oct. 1, so its numbers differ from these (a comparison table appears below). And one application can cover several strengths, while one drug can have dozens of applications. A year of 700 approvals is not 700 new medicines.

The record by decade

*Share of the period's applications with at least one product currently listed in Drugs@FDA with prescription or over-the-counter marketing status. GxRadar analysis of openFDA data through Oct. 28, 2026.

That last column shows how many old approvals no longer correspond to a product on the market. About one in five applications approved in the 1980s still has a marketed product, against more than four in five from the 2020s. Products leave the market for ordinary commercial reasons all the time, which is part of why some generics end up with only one maker.

1984 to 1999, a rush and a collapse

On Sept. 24, 1984, the Drug Price Competition and Patent Term Restoration Act became law as Public Law 98-417². Its Title I added the abbreviated application to the Federal Food, Drug, and Cosmetic Act. FDA's Orange Book preface³ notes that the amendments "established, among other things, the 505(b)(2) and 505(j) approval pathways." Only 78 of 1984's 207 approvals came after the signing date, so the first full year of the new system was 1985, with 291. By 1987 the count was 389.

Familiar molecules led the early lists. Ibuprofen had 80 original ANDA approvals between 1984 and 1989 in Drugs@FDA, propranolol 58 and haloperidol 33. GxRadar's history of the Hatch-Waxman Act explains the bargain behind the law.

Approvals fell from 359 in 1988 to 147 in 1989 and 59 in 1990, the lowest year in the record. Those were the years of the generic drug scandal. The HHS Office of Inspector General issued a report on FDA's generic approval process on Aug. 17, 1989, requested "after disclosures were made of fraud and corruption within the generic drug application review process," according to the inspector general's 1992 follow-up⁴. That follow-up says HHS reported the review process to the President and Congress as a material weakness from 1989 through 1991. GxRadar's account of the 1989 scandal covers the convictions and the debarment law that followed.

Recovery was slow. The 1990s averaged 175 approvals a year, fewer than the late 1980s, and did not pass 1987's level once.

2000 to 2026, growth and the user fee era

Approvals in the 2000s roughly doubled the 1990s total, peaking at 470 in 2007, and the count stayed between 400 and 510 a year from 2007 through 2014. The first generic drug user fee law, GDUFA I, was signed into law on July 9, 2012, according to FDA's 2024 guidance on ANDA amendments⁵. GxRadar explains how the money works in GDUFA, the user fees that pay for generic drug review.

Calendar approvals went from 406 in 2013 to 833 in 2017, the highest year on record. They have stayed within a narrower band since. The table compares GxRadar's calendar count with the fiscal-year approvals in FDA's monthly activity reports, from the fiscal 2013 report¹¹ to the fiscal 2025 report¹⁶.

Some of the gap is calendar and some is method. FDA's fiscal 2019 report says its approval counts were revised in April 2019 to capture "all approval actions on original applications, including split approvals," which helps explain that year's 935.

What gets approved changed too. The FDA Reauthorization Act of 2017 created competitive generic therapy designation, under section 506H of the drug law, according to FDA's FDARA activity reports¹⁸, and FDA's CGT approvals list⁸, updated Nov. 3, 2026, now has 533 entries, starting with five in 2018 and reaching 97 in 2025. In fiscal 2025, FDA's Office of Generic Drugs presentation⁷ from April 2026 says, the agency approved or tentatively approved 939 ANDAs, including 125 complex generics and 92 first generics. The first generics page⁹ notes that "approved drugs are not always available on or after the listed approval date."

The most-approved ingredients since 2020 mix old and new. Since 2020, potassium chloride has had 36 original ANDA approvals in Drugs@FDA, famotidine 32, doxycycline hyclate 31 and esomeprazole 31, and rivaroxaban, a blood thinner FDA listed among its notable generic approvals of fiscal 2025, has 25.

Where 2026 stands

With 579 original approvals through Oct. 28, 2026 is on pace for about 700 if the final two months match the first 10, which would be above 2025's 648. FDA's fiscal 2025 performance report¹⁷ shows median approval time for applications received in fiscal 2023 at 511 days, so a year's approvals largely reflect applications filed in earlier years.

FDA's generic drug facts page says a single generic competitor can cut prices by 30 percent and five competitors are associated with drops of nearly 85 percent, figures it cites alongside its description of the Drug Competition Action Plan¹⁰ begun in 2017. Approvals that clear GxRadar's data feed each week appear on the radar page, and the 2025 details are in generic drug approvals in 2025, by the numbers.