Nubeqa generics — when can they launch?
Nubeqa (darolutamide) · Bayer · 9 active US patents · 0 expired
Where Nubeqa sits in the generic timeline
Mid-term cliff: earliest active US patent for Nubeqa 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.
- Composition of Matter — 5 patents
- Method of Use — 3 patents
- Formulation — 1 patent
FDA U-codes carved out by Nubeqa 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-4209 | (no description) |
U-4208 | (no description) |
U-4210 | (no description) |
Sample patent estate
Showing 6 of 9 active US patents. View full estate on the Nubeqa drug page →
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This patent protects compounds of formula (I) and their pharmaceutically acceptable salts, as well as compositions and methods of treating with these compounds.USPTO title: Androgen receptor modulating compounds
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This patent protects compounds of formula (I) and their pharmaceutically acceptable salts, as well as compositions and methods of treating with them.USPTO title: Androgen receptor modulating compounds
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This patent protects compounds of formula (I) and their pharmaceutically acceptable salts, which are used to modulate the androgen receptor.USPTO title: Androgen receptor modulating compounds
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This patent protects compounds of formula (I) and their pharmaceutically acceptable salts, as well as compositions and methods of treating with these compounds.USPTO title: Androgen receptor modulating compounds
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This patent protects stable crystalline forms of a specific carboxamide derivative and its diastereomers, which are potent androgen receptor modulators.USPTO title: Carboxamide derivative and its diastereomers in stable crystalline form
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This patent protects stable crystalline forms of the Nubeqa active substance and methods for preparing these crystalline forms.USPTO title: Carboxamide derivative and its diastereomers in stable crystalline form
Sources
- FDA Orange Book — patents listed against Nubeqa (NDA filed 2019)
- Nubeqa drug profile — full patent estate, indications, clinical trials, pricing
- Bayer 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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