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Patent and exclusivity dates by year

Patent and exclusivity dates FDA's Orange Book lists for NDAs on its Paragraph IV list, as captured on 14 October 2026, by year.

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.

This page covers only NDAs that FDA's Paragraph IV list names and that have Orange Book listings. It does not cover other NDAs or any BLA. NCE exclusivity dates are here as FDA lists them; NCE-1 dates, computed from them, are on the NCE-1 calendar.

Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.

NCE-1, one year before a listed NCE exclusivity date and the one date Drybench computes, is on its own page: NCE-1 dates from the Orange Book