Vibativ generics — when can they launch?
Vibativ (TELAVANCIN HYDROCHLORIDE) · Cumberland · 2 active US patents · 0 expired
Where Vibativ sits in the generic timeline
Imminent generic cliff: earliest active US patent for Vibativ 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.
- Composition of Matter — 2 patents
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Vibativ drug page →
-
This patent protects hydrochloride salts of telavancin with a specific chloride ion content, which have improved stability during storage at ambient temperatures.USPTO title: Hydrochloride salts of a glycopeptide phosphonate derivative
-
This patent protects hydrochloride salts of telavancin with a specific chloride ion content, which have improved stability during storage at ambient temperatures.USPTO title: Hydrochloride salts of a glycopeptide phosphonate derivative
Sources
- FDA Orange Book — patents listed against Vibativ (NDA filed 2009)
- Vibativ drug profile — full patent estate, indications, clinical trials, pricing
- Cumberland 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 Vibativ — 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 →