Jevtana Kit generics — when can they launch?
Jevtana Kit (cabazitaxel) · Accord Hlthcare · 9 active US patents · 1 expired
Where Jevtana Kit sits in the generic timeline
All listed Orange Book patents for Jevtana Kit 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.
- Other — 5 patents
- Method of Use — 4 patents
FDA U-codes carved out by Jevtana Kit 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-2753 | (no description) |
U-2856 | (no description) |
U-3200 | (no description) |
U-4334 | (no description) |
Sample patent estate
Showing 6 of 9 active US patents. View full estate on the Jevtana Kit drug page →
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This patent protects an acetone solvate of dimethoxydocetaxel and its process of preparation.USPTO title: Acetone solvate of dimethoxy docetaxel and its process of preparation
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This patent protects the use of cabazitaxel in combination with prednisone or prednisolone for treating prostate cancer, particularly metastatic prostate cancer.USPTO title: Antitumoral use of cabazitaxel
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This patent protects the use of cabazitaxel in combination with prednisone or prednisolone for treating prostate cancer, particularly metastatic prostate cancer.USPTO title: Antitumoral use of cabazitaxel
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This patent protects the use of cabazitaxel in combination with prednisone or prednisolone for treating prostate cancer, particularly metastatic prostate cancer.USPTO title: Antitumoral use of cabazitaxel
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This patent protects the use of cabazitaxel in combination with prednisone or prednisolone for treating metastatic prostate cancer.USPTO title: Antitumoral use of cabazitaxel
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This patent protects the use of a compound, specifically cabazitaxel, in combination with prednisone or prednisolone, for treating prostate cancer.USPTO title: Antitumoral use of cabazitaxel
Sources
- FDA Orange Book — patents listed against Jevtana Kit (NDA filed 2010)
- Jevtana Kit drug profile — full patent estate, indications, clinical trials, pricing
- Accord Hlthcare 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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