Vivjoa generics — when can they launch?
Vivjoa (OTESECONAZOLE) · Mycovia Pharms · 5 active US patents · 0 expired
Where Vivjoa sits in the generic timeline
Mid-term cliff: earliest active US patent for Vivjoa expires in 2031 (~5 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.
- Composition of Matter — 3 patents
- Method of Use — 2 patents
FDA U-codes carved out by Vivjoa 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-3366 | (no description) |
Sample patent estate
Showing 5 of 5 active US patents. View full estate on the Vivjoa drug page →
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This patent protects compounds with metalloenzyme modulating activity and methods for treating diseases or disorders mediated by such metalloenzymes.USPTO title: Metalloenzyme inhibitor compounds
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This patent protects metalloenzyme inhibitor compounds and methods for treating diseases, disorders, or symptoms mediated by metalloenzymes.USPTO title: Metalloenzyme inhibitor compounds
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This patent protects compounds with metalloenzyme modulating activity and methods for treating diseases or symptoms mediated by such metalloenzymes.USPTO title: Metalloenzyme inhibitor compounds
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This patent protects polymorphic forms of compound 1 or 1a and processes for preparing them, which are used as antifungal agents.USPTO title: Antifungal compounds and processes for making
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This patent protects new polymorphic forms of the antifungal compound and processes for making them.USPTO title: Antifungal compounds and processes for making
Sources
- FDA Orange Book — patents listed against Vivjoa (NDA filed 2022)
- Vivjoa drug profile — full patent estate, indications, clinical trials, pricing
- Mycovia Pharms patent portfolio
- Patent cliff 2031 — 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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