When does each brand lose its FDA-listed protection, and are generics or biosimilars already approved? Listed patents, regulatory exclusivities (new chemical entity, orphan, new indication, pediatric, biologic 12-year) and approved copies, for one drug or a whole class.
One row per brand application. The bar runs to the last listed patent or exclusivity; hover a marker for the date.
Status today, the protection behind it, and the copies already approved.
Exclusivity ends, last patents and first copies, newest past events faded.
How to read this. Dates are what FDA lists: patent expiry dates from the Orange Book (including pediatric extensions) and exclusivity end dates for NDAs, and for biologics the 12-year reference product exclusivity (listed, or estimated from the first approval when FDA no longer lists it) and orphan exclusivity from the Purple Book. A copy is an approved ANDA generic with the same ingredient, dosage form and route, or a 351(k) biosimilar of the reference product.
Not a launch forecast. Patents are challenged, invalidated or settled, and settlements often set a confidential entry date; some patents cover only one use, strength or device; delisted patents are left out. Biologic patents are not listed with dates in the Purple Book. Generic approval does not mean launch: "on the market" means at least one approved copy is not marked discontinued. Data: FDA Orange Book, FDA Purple Book, refreshed weekly.