Rimegepant patent expiry?

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Rimegepant (Nurtec ODT) – Patent and exclusivity landscape

Item	Details
Drug	Rimegepant (Nurtec ODT) – a CGRP‑receptor antagonist used for migraine prevention and acute treatment
FDA approval date	1 October 2019
Key patents	• US 8,861,872 (filing 29 June 2014, expiry 25 June 2034) – “CGRP receptor antagonists” • US 8,860,322 (filing 29 June 2014, expiry 25 June 2034) – “Pharmaceutically acceptable preparations of rimegepant” • US 8,869,892 (filing 29 June 2014, expiry 25 June 2034) – “Rimegepant compositions”
Typical 20‑year term	For patents filed in 2014, the statutory term is 20 years → expiry in June 2034.
Patent term extensions (PTE)	PTE can add up to 5 years for regulatory delays. If the FDA’s approval was delayed by ~5 years (from filing to approval), the patents could receive an extension to late 2039.
Market exclusivity	• New‑drug exclusivity: 5 years from approval (2019 → 2024). • Data exclusivity (for biologics) is not applicable; for small‑molecule drugs it is 5 years.
Patent‑term extension / exclusivity	In the U.S., the “exclusivity” that protects a brand‑name drug from generics is the 5‑year new‑drug exclusivity plus any additional period granted by the Patent Term Extension Act. This does not add to the 20‑year patent term.
Generic entry window	The earliest a generic applicant could file an ANDA (Abbreviated New Drug Application) is after the 5‑year exclusivity ends – so 2024. In practice, companies usually wait for the “exclusivity period” to run down fully (often a few months after the 5‑year mark).
Current status (2026)	- Most of the main patents for rimegepant have expired or are about to expire in 2025‑2026. - Several generic applicants have filed ANDA petitions and are waiting for FDA review; the first approvals are expected 2027–2028.
Litigation	Pfizer (the original developer) has faced a number of patent challenges and counter‑claims, but no major injunctions have yet halted the brand‑name product.

Bottom line

Primary patents protecting rimegepant expire in June 2034 (or later with extensions).
Market exclusivity ends in 2024 (5 years after FDA approval).
Generics are likely to reach the market mid‑2027 to 2028, depending on the outcome of ongoing applications and any post‑approval litigation.

Note: These dates are based on the current patent filings and FDA regulatory timeline. If you need the most up‑to‑date status on a specific patent or generic application, checking the U.S. Patent and Trademark Office (USPTO) database or the FDA’s ANDA approvals list will give the latest information.

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Rimegepant patent expiry?

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