What FDA's yearly first generics lists show

On April 6, 2026, FDA added 27 entries to its list of first generic approvals in a single day. All 27 were for dapagliflozin, a diabetes and kidney drug: 15 for plain dapagliflozin tablets, 10 for an extended-release combination with metformin and two for a combination with saxagliptin, according to FDA's 2026 first generics list¹.

That one day explains a lot about how to read the list. FDA counts approvals, and when several manufacturers win approval for the same product on the same day, each one gets its own line. A year with 90 entries may cover far fewer medicines.

First generics matter because they end a brand's monopoly. Prices fall when the first copy arrives and fall much further when more follow.

What FDA counts as a first generic

FDA's own definition is short. First generics, the agency says on its first generics page¹, are "the first approval by FDA which permits a manufacturer to market a generic drug product in the United States." It adds a caution on the same page: "Approved drugs are not always available on or after the listed approval date."

A second, narrower definition governs review order. Under criteria FDA set out in a 2014 Federal Register notice⁶, an application is treated as a first generic for prioritization if it is a first-to-file application eligible for 180-day exclusivity, or one with no blocking patents or exclusivities, and no generic of that product has been approved before. FDA says it prioritizes review of these submissions.

Each entry is product-specific. A new dosage form or strength can earn a first generic entry even when other forms of the same molecule have had generics for years. That is why ordinary-sounding products, such as an oral solution of a long-generic blood pressure drug, appear on recent lists. The glossary entry has a one-line version.

How many there have been

FDA publishes one first generics page per calendar year, with links to earlier years on its previous years page³. GxRadar counted the entries on each page and the number of distinct brand products they reference. The 2018 count of brand products is approximate because that page lists most brands as plain text rather than linked application numbers.

Fiscal-year counts differ because FDA's fiscal year starts Oct. 1. The fiscal 2025 activity report⁷ counts 92 first-time generic approvals, up from 70 in the fiscal 2024 report¹². FDA's economists use yet another unit. Their study of 2023 approvals counted 40 drug products with first generic approvals that year, against 90 entries on the calendar-year list.

The 2025 list² shows the range of what qualifies. It runs from a vitamin K injection approved Jan. 3 to a diabetes tablet approved Dec. 30, with inhalers, eye drops, cancer drugs and an iodinated contrast agent in between. GxRadar's approvals page tracks all original generic approvals, first or not, and our tally of generic approvals in 2025 puts that year's list in context.

Why the first one matters for price

A first generic rarely brings the deepest discount on its own. A 2019 FDA analysis of generic competition and prices⁸ found that with a single generic maker, the generic's average manufacturer price ran 39 percent below the brand's price before generic entry. With two makers the gap was 54 percent, with four it was 79 percent, and with six or more it exceeded 95 percent. Our explainer on why generic prices fall as competitors enter walks through that curve.

A first entrant is often alone for a while. If it won 180-day exclusivity, FDA cannot approve later challengers until that period runs, though the brand company can sell an authorized generic in the meantime. In FDA's figures, the larger declines arrive with the second, third and fourth makers.

FDA's savings study for 2023¹⁰ puts numbers on the split. First generics produced about $2.4 billion of the $18.6 billion in estimated 12-month savings from that year's approvals, roughly 13 percent. Nine of the 10 products with the largest savings were later generics joining markets that already had a copy.

Two molecules in the NADAC data

CMS's National Average Drug Acquisition Cost survey, or NADAC, records what pharmacies pay. GxRadar's analysis of CMS NADAC files¹¹ through October 2026 covers two drugs whose first generics were approved inside the survey's history. FDA's 2016 list⁴ shows the first generic rosuvastatin tablets approved April 29, 2016. Its 2018 list⁵ shows the first generic tadalafil tablets in the 2.5 to 20 mg strengths approved May 22, 2018.

Both follow the same shape. For the first two to six months in the series, the generic price sat near where it started. Then it fell by more than 90 percent within months. For tadalafil, the first generic price in the survey appeared seven months after FDA's approval date. The data cannot say why, and FDA's own list warns that approval and availability are different things. Current prices are on the rosuvastatin and tadalafil pages, and GxRadar compares both with duloxetine in a piece on how fast generic prices fell.

Approved is not the same as sold

FDA measured the gap directly in a 2021 report on the marketing of first generics⁹. It reviewed 687 first generics approved from January 2010 to June 2017. Of the 375 that had challenged a brand patent with a Paragraph IV certification, only 53 percent were on the market within six months of approval and about 69 percent within two years.

Settlements made the gap wider. Where the brand and generic companies settled their Hatch-Waxman patent case, 38 percent of first generics were marketed within six months and 57 percent within two years. Where a court decided the case, the figures were 65 percent and 78 percent. Across all 687, the report counted 118 that had not been marketed at all.

FDA's 2026 first generics page, last updated Oct. 5, 2026, lists approvals through Aug. 31. September and October approvals will appear in the next update, and the fiscal 2026 total will appear in the activity reports FDA posts after the fiscal year closes.