Patent and exclusivity dates in 2045 for NDAs on FDA's Paragraph IV list, as FDA lists them

Each patent and exclusivity date in 2045 that FDA's Orange Book lists, as captured on 14 October 2026, for the 607 NDAs that FDA's Paragraph IV list names, as captured on 17 October 2026, and whose Orange Book capture lists a patent or exclusivity. Each entry is named by its rule and linked to its NDA page. A date here belongs to one patent or one exclusivity on the products named; the same NDA may have other listed dates, earlier or later, so no date here 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

Paragraph IV list captured

17 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.