Osphena generics — when can they launch?
Osphena (OSPEMIFENE) · Duchesnay · 2 active US patents · 0 expired
Where Osphena sits in the generic timeline
All listed Orange Book patents for Osphena have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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 — 1 patent
- Formulation — 1 patent
FDA U-codes carved out by Osphena 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-905 | (no description) |
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Osphena drug page →
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This patent protects a method for increasing the effectiveness of a specific type of medication when taken orally with food.USPTO title: Method for enhancing the bioavailablity of ospemifene
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This patent protects solid formulations of ospemifene, specifically granulates containing the active compound and intra-granular excipients.USPTO title: Solid formulations of ospemifene
Sources
- FDA Orange Book — patents listed against Osphena (NDA filed 2013)
- Osphena drug profile — full patent estate, indications, clinical trials, pricing
- Duchesnay patent portfolio
- Patent cliff 2026 — 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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