FOSCARBIDOPA generics — when can they launch?
FOSCARBIDOPA (FOSCARBIDOPA) · AbbVie GK · 4 active US patents · 0 expired
Where FOSCARBIDOPA sits in the generic timeline
Long-dated protection: earliest active US patent for FOSCARBIDOPA 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.
- Method of Use — 3 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by FOSCARBIDOPA 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-4030 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the FOSCARBIDOPA drug page →
-
This patent protects carbidopa prodrugs, pharmaceutical combinations, and methods for treating Parkinson's disease using these compounds.USPTO title: Carbidopa prodrug
-
This patent protects methods of treating Parkinson's disease using carbidopa prodrugs and/or L-dopa prodrugs.USPTO title: Carbidopa and L-dopa prodrugs and methods of use
-
This patent protects methods of treating Parkinson's disease using carbidopa prodrugs and L-dopa prodrugs.USPTO title: Carbidopa and L-dopa prodrugs and methods of use
-
This patent protects a method of treating Parkinson's disease and associated conditions by subcutaneously administering a composition of levodopa 4â²-monophosphate and carbidopa 4â²-monophosphate in a 20:1 weight ratio.USPTO title: Pharmaceutical formulations for subcutaneous administration
Sources
- FDA Orange Book — patents listed against FOSCARBIDOPA (NDA filed 2024)
- FOSCARBIDOPA drug profile — full patent estate, indications, clinical trials, pricing
- AbbVie GK patent portfolio
- 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.
Get generic entry alerts
Free Pharma CI alerts on FOSCARBIDOPA — 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 →