How dates are derived

cliffwatch computes one number per branded product: the earliest generic-entry date as listed. It is the latest date on which any unexpired, non-delisted patent or any unexpired exclusivity in the FDA Orange Book still blocks a generic application.

The rule

1. Take every listed patent on the product that is not delisted and has not expired. Call the latest expiry P.
2. Take every unexpired exclusivity. Call the latest expiry E.
3. The date is the later of P and E. If neither exists, the product is shown as open now.
4. If every patent expiring on or after P is a method-of-use patent, the product is flagged carve-out possible: a generic may seek approval without that indication under section viii.
5. Pediatric exclusivity is already reflected in the extended expiry that FDA publishes, so nothing is added twice.

What it does not account for

Patent litigation, settlements with licensed entry dates, 30-month stays, 180-day first-filer exclusivity, at-risk launches, and patents a company holds but did not list. FDA records listings as submitted and does not verify them; since 2023 the FTC has challenged several hundred listings and many were removed. Treat every date here as a regulatory fact that can move, not a forecast of when generics launch.

Source and refresh

FDA publishes the Orange Book data files monthly, with ad-hoc updates. cliffwatch checks daily, re-derives every date, and records every change as an event on the drug's page. Nothing on this site is investment advice.