Vocabria generics — when can they launch?
Vocabria (CABOTEGRAVIR) · GSK · 17 active US patents · 3 expired
Where Vocabria sits in the generic timeline
Imminent generic cliff: earliest active US patent for Vocabria expires in 2027 (~1 year 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.
- Method of Use — 12 patents
- Formulation — 4 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by Vocabria 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-3405 | (no description) |
U-3348 | (no description) |
Sample patent estate
Showing 6 of 17 active US patents. View full estate on the Vocabria drug page →
-
This patent protects pharmaceutical compositions of TMC278 for intramuscular or subcutaneous injection to treat and prevent HIV infection.USPTO title: Aqueous suspensions of TMC278
-
This patent protects pharmaceutical compositions of TMC278 for intramuscular or subcutaneous injection to treat and prevent HIV infection.USPTO title: Aqueous suspensions of TMC278
-
This patent protects the molecule (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide and its related compounds.USPTO title: (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent
-
This patent protects a compound useful as an anti-HIV agent, including its pharmaceutically acceptable salts and compositions.USPTO title: (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent
-
This patent protects a compound useful as an anti-HIV agent, including its pharmaceutically acceptable salts and compositions.USPTO title: (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent
-
This patent protects pharmaceutical compositions of a specific compound useful in treating or preventing HIV infections.USPTO title: Pharmaceutical compositions
Sources
- FDA Orange Book — patents listed against Vocabria (NDA filed 2021)
- Vocabria drug profile — full patent estate, indications, clinical trials, pricing
- GSK patent portfolio
- 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 Vocabria — 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 →