FOSAPREPITANT DIMEGLUMINE generics — when can they launch?
FOSAPREPITANT DIMEGLUMINE (FOSAPREPITANT DIMEGLUMINE) · · 2 active US patents · 0 expired
Where FOSAPREPITANT DIMEGLUMINE sits in the generic timeline
Long-dated protection: earliest active US patent for FOSAPREPITANT DIMEGLUMINE extends to 2039 (~13 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 — 2 patents
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the FOSAPREPITANT DIMEGLUMINE drug page →
-
This patent protects stable compositions of fosaprepitant or a pharmaceutically acceptable salt thereof, lacking polysorbate 80, and methods of their preparation.USPTO title: Compositions of fosaprepitant and methods of preparation
-
This patent protects stable compositions of fosaprepitant or a pharmaceutically acceptable salt thereof, lacking polysorbate 80, and containing dual functional excipients.USPTO title: Injectable fosaprepitant composition
Sources
- FDA Orange Book — patents listed against FOSAPREPITANT DIMEGLUMINE (NDA filed 2008)
- FOSAPREPITANT DIMEGLUMINE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2039 — 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.
Get generic entry alerts
Free Pharma CI alerts on FOSAPREPITANT DIMEGLUMINE — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →