FDA drug patent cliffs, 2026–2035

A patent cliff is the year a brand product loses its last remaining protection — the latest of all its listed patent-expiry dates and marketing-exclusivity dates in the FDA Orange Book. We count brand (NDA) applications only; generics (ANDA) are the products that enter after a cliff, so they are excluded. Applications whose protection has already lapsed are not counted as upcoming.

Figures are computed directly from the official FDA Orange Book data file (snapshot 2026-06-16T17:49:24.043Z). Listed patents reflect those an NDA holder submits under 21 U.S.C. 355 and are not exhaustive; the actual date a generic can launch can also turn on Paragraph IV litigation and 180-day exclusivity. Free to reuse with attribution to Assyro.