ESMOLOL HYDROCHLORIDE generics — when can they launch?
ESMOLOL HYDROCHLORIDE (ESMOLOL HYDROCHLORIDE) · · 4 active US patents · 0 expired
Where ESMOLOL HYDROCHLORIDE sits in the generic timeline
Long-dated protection: earliest active US patent for ESMOLOL HYDROCHLORIDE extends to 2033 (~7 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 — 4 patents
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the ESMOLOL HYDROCHLORIDE drug page →
-
This patent protects a ready-to-use injectable pharmaceutical composition containing Esmolol hydrochloride that can be stored in a modified flexible plastic container.USPTO title: Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container
-
This patent protects a ready-to-use injectable pharmaceutical composition of Esmolol hydrochloride in a modified flexible plastic container that can be heat-sterilized.USPTO title: Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container
-
This patent protects a ready-to-use injectable pharmaceutical composition of Esmolol hydrochloride in a modified flexible plastic container that can be heat-sterilized.USPTO title: Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container
-
This patent protects a ready-to-use injectable pharmaceutical composition containing Esmolol hydrochloride that can be stored in a modified flexible plastic container.USPTO title: Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container
Sources
- FDA Orange Book — patents listed against ESMOLOL HYDROCHLORIDE (NDA filed 1986)
- ESMOLOL HYDROCHLORIDE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2033 — 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 ESMOLOL HYDROCHLORIDE — 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 →