Zurzuvae generics — when can they launch?
Zurzuvae (ZURANOLONE) · Biogen · 15 active US patents · 0 expired
Where Zurzuvae sits in the generic timeline
Long-dated protection: earliest active US patent for Zurzuvae extends to 2034 (~8 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 — 9 patents
- Composition of Matter — 6 patents
FDA U-codes carved out by Zurzuvae 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-2552 | (no description) |
Sample patent estate
Showing 6 of 15 active US patents. View full estate on the Zurzuvae drug page →
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This patent protects a class of 19-nor C3,3-disubstituted C21-pyrazolyl steroids and their pharmaceutically acceptable salts, useful for treating various CNS-related conditions.USPTO title: 19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof
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This patent protects a class of steroids and their salts for use in preventing and treating various central nervous system-related conditions.USPTO title: 19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof
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This patent protects a class of steroids and their salts for use in preventing and treating various central nervous system-related conditions.USPTO title: 19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof
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This patent protects a class of steroids and their salts for use in preventing and treating various central nervous system-related conditions.USPTO title: 19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof
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This patent protects a class of 19-nor C3,3-disubstituted C21-pyrazolyl steroids and their pharmaceutically acceptable salts, useful for treating various CNS-related conditions.USPTO title: 19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof
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This patent protects a class of 19-nor C3,3-disubstituted C21-pyrazolyl steroids and their pharmaceutically acceptable salts, useful for treating various CNS-related conditions.USPTO title: 19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof
Sources
- FDA Orange Book — patents listed against Zurzuvae (NDA filed 2023)
- Zurzuvae drug profile — full patent estate, indications, clinical trials, pricing
- Biogen patent portfolio
- Patent cliff 2034 — 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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