Nurtec Odt generics — when can they launch?
Nurtec Odt (Rimegepant Sulfate) · Pfizer · 3 active US patents · 0 expired
Where Nurtec Odt sits in the generic timeline
Long-dated protection: earliest active US patent for Nurtec Odt extends to 2033 (~7 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Method of Use — 2 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by Nurtec Odt patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-2718 | (no description) |
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the Nurtec Odt drug page →
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This patent protects the hemisulfate salt of a specific compound, as well as crystalline forms of this salt, used as a CGRP receptor antagonist.USPTO title: N-(5S,6S,9R)-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5H-ctclohepta[b]Pyridin-9-yl-4-(2-oxo-2,3-dihydro-1H-imidazo[4,5-b]pyridin-1-carboxylate salt
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This patent protects novel compounds that are CGRP receptor antagonists and their use in treating various disorders, including migraine and other headaches.USPTO title: CGRP receptor antagonists
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This patent protects methods of treating CGRP-related disorders, such as migraine, using rimegepant or a pharmaceutically acceptable salt thereof.USPTO title: Rimegepant for CGRP related disorders
Sources
- FDA Orange Book — patents listed against Nurtec Odt (NDA filed 2020)
- Nurtec Odt drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer patent portfolio
- Patent cliff 2033 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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