PACLITAXEL generics — when can they launch?
PACLITAXEL (PACLITAXEL) · · 11 active US patents · 3 expired
Where PACLITAXEL sits in the generic timeline
All listed Orange Book patents for PACLITAXEL 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 — 7 patents
- Method of Use — 4 patents
FDA U-codes carved out by PACLITAXEL 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-1290 | (no description) |
U-1434 | (no description) |
Sample patent estate
Showing 6 of 11 active US patents. View full estate on the PACLITAXEL drug page →
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This patent protects methods of treating proliferative diseases, such as cancer, using a combination of taxane in a nanoparticle composition and other therapies.USPTO title: Combinations and modes of administration of therapeutic agents and combination therapy
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This patent protects methods of treating proliferative diseases, such as cancer, using a combination of taxane in a nanoparticle composition and other therapies.USPTO title: Combinations and modes of administration of therapeutic agents and combination therapy
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This patent protects methods of treating proliferative diseases, such as cancer, using a combination of taxane in a nanoparticle composition and other therapies.USPTO title: Combinations and modes of administration of therapeutic agents and combination therapy
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This patent protects methods of treating proliferative diseases, such as cancer, using a combination of taxane in a nanoparticle composition and other therapies.USPTO title: Combinations and modes of administration of therapeutic agents and combination therapy
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This patent protects methods of treating proliferative diseases, such as cancer, using a combination of taxane in a nanoparticle composition and other therapies.USPTO title: Combinations and modes of administration of therapeutic agents and combination therapy
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This patent protects methods for treating non-small-cell lung cancer and prostate cancer using specific combinations of nanoparticles and other agents.USPTO title: Methods of treating cancer
Sources
- FDA Orange Book — patents listed against PACLITAXEL (NDA filed 1992)
- PACLITAXEL drug profile — full patent estate, indications, clinical trials, pricing
- 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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