PEMETREXED generics — when can they launch?
PEMETREXED (PEMETREXED) · · 3 active US patents · 0 expired
Where PEMETREXED sits in the generic timeline
Long-dated protection: earliest active US patent for PEMETREXED extends to 2035 (~9 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 1 patent
- Formulation — 1 patent
- Method of Use — 1 patent
FDA U-codes carved out by PEMETREXED 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-4246 | (no description) |
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the PEMETREXED drug page →
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This patent protects crystalline forms of pemetrexed diacid, specifically Forms 1 and 2, and methods for manufacturing them.USPTO title: Crystalline forms of pemetrexed diacid and manufacturing processes therefor
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This patent protects pemetrexed formulations that remain stable in a non-aqueous solvent for at least 48 hours or 24 months when stored at 2-8°C.USPTO title: Pemetrexed formulations
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This patent protects formulations of the drug pemetrexed that remain stable in a non-aqueous solvent for at least 48 hours or 24 months when stored at 2-8°C.USPTO title: Pemetrexed formulations
Sources
- FDA Orange Book — patents listed against PEMETREXED (NDA filed 2004)
- PEMETREXED drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2035 — 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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