Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
427 brand-name drugs lose their patent protection between 2026 and 2031. When protection ends, generic manufacturers can apply to sell the same medicine, usually at a much lower price, and the original maker usually loses most of the sales within a year or two. This page tracks which drugs, which companies, and when, from the FDA's own Orange Book.
This is the earliest date a generic could enter; it is not a guarantee one will. We calculate it as the later of the last patent the company listed with the FDA and the last regulatory exclusivity. Companies often reach settlement agreements with generic makers for a different date, and those agreements are not public in this data.
A different, earlier cliff:852 FDA regulatory exclusivities (new chemical entity, orphan drug, new indication, pediatric) end through 2031, separately from patents.
Corlanor (ivabradine)Amgen · 4 patents · December 12, 2026
Questions
What is a patent cliff?
The point when a drug's patent protection ends and generic manufacturers can apply to sell the same medicine, usually at a much lower price and usually taking most of the sales.
How many drugs lose patent protection between 2026 and 2031?
427 brand-name drugs lose patent protection between 2026 and 2031, per the FDA Orange Book.
Which company has the most patent expirations?
Merck Sharp AND Dohme, with 18 drugs losing protection between 2026 and 2031 in this data.
Where does this data come from?
The FDA Orange Book, the official record of which patents cover which approved drug. It updates monthly, and every date here is the later of the last listed patent and the last regulatory exclusivity.
Dates from the FDA Orange Book, the official record of which patents cover
which approved drug; updated monthly. Facts only, not investment advice. Verify against the
Orange Book and primary filings. pdufa.bio is not affiliated with the FDA.
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