Taxotere generics — when can they launch?
Taxotere (Docetaxel) · Sanofi · 18 active US patents · 0 expired
Where Taxotere sits in the generic timeline
Mid-term cliff: earliest active US patent for Taxotere 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.
- Method of Use — 11 patents
- Formulation — 7 patents
FDA U-codes carved out by Taxotere 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-2998 | (no description) |
U-2561 | (no description) |
U-2563 | (no description) |
U-2560 | (no description) |
U-1789 | (no description) |
U-881 | (no description) |
Sample patent estate
Showing 6 of 18 active US patents. View full estate on the Taxotere drug page →
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This patent protects non-aqueous taxane pro-emulsion formulations and methods of making and using them, including kits that include these formulations.USPTO title: Non-aqueous taxane pro-emulsion formulations and methods of making and using the same
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This patent protects non-aqueous taxane pro-emulsion formulations and methods of making and using them, including kits that include these formulations.USPTO title: Non-aqueous taxane pro-emulsion formulations and methods of making and using the same
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This patent protects non-aqueous taxane pro-emulsion formulations and methods of making and using them, including kits that include these formulations.USPTO title: Non-aqueous taxane pro-emulsion formulations and methods of making and using the same
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This patent protects non-aqueous, ethanol-free formulations of taxanes, including docetaxel, and methods of using these formulations.USPTO title: Non-aqueous taxane formulations and methods of using the same
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This patent protects non-aqueous, ethanol-free formulations of taxanes, including docetaxel, and methods of using these formulations.USPTO title: Non-aqueous taxane formulations and methods of using the same
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This patent protects non-aqueous, ethanol-free formulations of taxanes, such as docetaxel, and methods of using these formulations.USPTO title: Non-aqueous taxane formulations and methods of using the same
Sources
- FDA Orange Book — patents listed against Taxotere (NDA filed 1996)
- Taxotere drug profile — full patent estate, indications, clinical trials, pricing
- Sanofi 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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