Patent and exclusivity dates in 2046 for NDAs, as FDA's Orange Book lists them

Patent and exclusivity dates in 2046 that FDA's Orange Book lists for an NDA, as captured on 14 October 2026, counted by rule and half-year. That capture lists a patent or exclusivity for 1,411 NDAs. Each half-year page names every entry by its rule and links it to its NDA page. A count here is of listed dates, not of NDAs or products: one NDA may have several dates, so no count stands for a product.

FDA capture · review pending. Each date is shown as captured from FDA's Orange Book files. Dates are as FDA lists them, and Drybench computes none; patent dates are submitted by the applicant, and FDA does not verify them. Spreadsheet day numbers are shown as dates; a cell that cannot be read as one date is left off this page and shown as written on its NDA page. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.

Orange Book captured

14 October 2026

Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.