PEMETREXED DISODIUM generics — when can they launch?
PEMETREXED DISODIUM (PEMETREXED DISODIUM) · · 3 active US patents · 0 expired
Where PEMETREXED DISODIUM sits in the generic timeline
Long-dated protection: earliest active US patent for PEMETREXED DISODIUM 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.
- Formulation — 3 patents
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the PEMETREXED DISODIUM drug page →
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This patent protects a pharmaceutical composition of pemetrexed, specifically a ready-to-use injection with certain quality control standards.USPTO title: Pharmaceutical composition of pemetrexed
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This patent protects a pharmaceutical composition of pemetrexed, specifically a ready-to-use injection with certain quality control standards.USPTO title: Pharmaceutical composition of pemetrexed
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This patent protects a pharmaceutical composition of pemetrexed, specifically a ready-to-use injection with certain quality control standards.USPTO title: Pharmaceutical composition of pemetrexed
Sources
- FDA Orange Book — patents listed against PEMETREXED DISODIUM (NDA filed 2004)
- PEMETREXED DISODIUM 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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