Brexafemme generics — when can they launch?
Brexafemme (IBREXAFUNGERP CITRATE) · GSK · 5 active US patents · 0 expired
Where Brexafemme sits in the generic timeline
Mid-term cliff: earliest active US patent for Brexafemme expires in 2030 (~4 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.
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 — 3 patents
- Composition of Matter — 2 patents
FDA U-codes carved out by Brexafemme 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-3159 | (no description) |
Sample patent estate
Showing 5 of 5 active US patents. View full estate on the Brexafemme drug page →
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This patent protects novel derivatives of enfumafungin and their uses as antifungal agents to treat and/or prevent fungal infections.USPTO title: Antifungal agents
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This patent protects novel salts and polymorph forms of SCY-078, a glucan synthase inhibitor with antimicrobial activity.USPTO title: Salts and polymorphs of SCY-078
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This patent protects novel salts and polymorph forms of SCY-078, a glucan synthase inhibitor with antimicrobial activity.USPTO title: Salts and polymorphs of SCY-078
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This patent protects novel salts and polymorph forms of SCY-078, a glucan synthase inhibitor with antimicrobial activity.USPTO title: Salts and polymorphs of SCY-078
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This patent protects the use of enfumafungin derivative triterpenoid antifungal compounds to treat or prevent fungal infections in acidic conditions.USPTO title: Antifungal agents with enhanced activity in acidic pH
Sources
- FDA Orange Book — patents listed against Brexafemme (NDA filed 2021)
- Brexafemme drug profile — full patent estate, indications, clinical trials, pricing
- GSK patent portfolio
- Patent cliff 2030 — 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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