Winlevi generics — when can they launch?
Winlevi (CLASCOTERONE) · Sun Pharma · 8 active US patents · 0 expired
Where Winlevi sits in the generic timeline
Imminent generic cliff: earliest active US patent for Winlevi expires in 2027 (~1 year from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
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 — 5 patents
- Formulation — 3 patents
FDA U-codes carved out by Winlevi 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-2942 | (no description) |
U-3280 | (no description) |
Sample patent estate
Showing 6 of 8 active US patents. View full estate on the Winlevi drug page →
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This patent protects the use of 17α,21-dihydroxypregna-4,9-diene-3,20-dione and 17α,21-dihydroxypregna-4-ene-3,20-dione 17 and/or 21 esters as antiandrogenic agents.USPTO title: 17α, 21-dihydroxypregnene esters as antiandrogenic agents
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This patent protects a new enzymatic process for making certain compounds, including a new crystalline form of the active ingredient in the drug Winlevi.USPTO title: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
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This patent protects a new enzymatic process for making certain compounds, including a new form of the drug ingredient in Winlevi.USPTO title: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
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This patent protects a new enzymatic process for making certain compounds, including a new crystalline form of the active ingredient in the drug Winlevi.USPTO title: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
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This patent protects a new enzymatic process for making certain compounds, including a new form of the drug Winlevi.USPTO title: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
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This patent protects a new enzymatic process for making certain compounds, including a new crystalline form of the active ingredient in the drug Winlevi.USPTO title: Enzymatic process for obtaining 17 α-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Sources
- FDA Orange Book — patents listed against Winlevi (NDA filed 2020)
- Winlevi drug profile — full patent estate, indications, clinical trials, pricing
- Sun Pharma patent portfolio
- Patent cliff 2027 — 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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