Zepzelca generics — when can they launch?
Zepzelca (LURBINECTEDIN) · Jazz Pharmaceuticals · 4 active US patents · 0 expired
Where Zepzelca sits in the generic timeline
Mid-term cliff: earliest active US patent for Zepzelca expires in 2029 (~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.
- Method of Use — 4 patents
FDA U-codes carved out by Zepzelca 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-4299 | (no description) |
U-4212 | (no description) |
U-4305 | (no description) |
U-4252 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Zepzelca drug page →
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This patent protects a class of ecteinascidin analogs as antitumor agents.USPTO title: Ecteinascidin analogs for use as antitumour agents
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This patent protects methods for treating small cell lung cancer (SCLC) patients using lurbinectedin, either alone or in combination with other anticancer drugs.USPTO title: Method of treating SCLC and managing hepatotoxicity
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This patent protects methods for treating small cell lung cancer (SCLC) patients using lurbinectedin, either alone or in combination with other anticancer drugs.USPTO title: Method of treating SCLC and managing neutropenia
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This patent protects methods for treating small cell lung cancer (SCLC) patients using lurbinectedin, either alone or in combination with other anticancer drugs.USPTO title: Method of treating SCLC and managing thrombocytopenia
Sources
- FDA Orange Book — patents listed against Zepzelca (NDA filed 2020)
- Zepzelca drug profile — full patent estate, indications, clinical trials, pricing
- Jazz Pharmaceuticals patent portfolio
- Patent cliff 2029 — 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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