FOSTEMSAVIR TROMETHAMINE generics — when can they launch?
FOSTEMSAVIR TROMETHAMINE (FOSTEMSAVIR TROMETHAMINE) · · 2 active US patents · 0 expired
Where FOSTEMSAVIR TROMETHAMINE sits in the generic timeline
Imminent generic cliff: earliest active US patent for FOSTEMSAVIR TROMETHAMINE expires in 2027 (~2 years from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
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
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the FOSTEMSAVIR TROMETHAMINE drug page →
-
This patent protects prodrug compounds and their use in treating HIV infection, as well as intermediate compounds useful in making them.USPTO title: Prodrugs of piperazine and substituted piperidine antiviral agents
-
This patent protects prodrug compounds and their use in treating HIV infection, as well as intermediate compounds useful in making these prodrugs.USPTO title: Prodrugs of piperazine and substituted piperidine antiviral agents
Sources
- FDA Orange Book — patents listed against FOSTEMSAVIR TROMETHAMINE (NDA filed 2020)
- FOSTEMSAVIR TROMETHAMINE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2027 — 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 FOSTEMSAVIR TROMETHAMINE — 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 →