Paraplatin generics — when can they launch?
Paraplatin (Carboplatin) · MYLAN SEIYAKU Ltd · 3 active US patents · 0 expired
Where Paraplatin sits in the generic timeline
Long-dated protection: earliest active US patent for Paraplatin extends to 2045 (~19 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 Paraplatin drug page →
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This patent protects injectable formulations of carboplatin, specifically Paraplatin, with a pH of 5-7 and a dissolved oxygen level of at least 28 ppm.USPTO title: Injectable carboplatin formulations
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This patent protects injectable formulations of carboplatin, specifically Paraplatin, with a pH of 5-7 and a dissolved oxygen level of at least 28 ppm.USPTO title: Injectable carboplatin formulations
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This patent protects injectable formulations of carboplatin, specifically Paraplatin, with a pH of 5-7 and a dissolved oxygen level of at least 28 ppm.USPTO title: Injectable carboplatin formulations
Sources
- FDA Orange Book — patents listed against Paraplatin (NDA filed 1989)
- Paraplatin drug profile — full patent estate, indications, clinical trials, pricing
- MYLAN SEIYAKU Ltd patent portfolio
- Patent cliff 2045 — 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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