ESOMEPRAZOLE MAGNESIUM generics — when can they launch?
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM) · · 2 active US patents · 0 expired
Where ESOMEPRAZOLE MAGNESIUM sits in the generic timeline
Long-dated protection: earliest active US patent for ESOMEPRAZOLE MAGNESIUM extends to 2036 (~11 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 — 2 patents
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the ESOMEPRAZOLE MAGNESIUM drug page →
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This patent protects stable orally disintegrating tablets containing a proton pump inhibitor, specifically esomeprazole magnesium.USPTO title: Stable orally disintegrating pharmaceutical compositions
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This patent protects stable orally disintegrating tablets containing a proton pump inhibitor, specifically a formulation of the drug esomeprazole magnesium.USPTO title: Stable orally disintegrating pharmaceutical compositions
Sources
- FDA Orange Book — patents listed against ESOMEPRAZOLE MAGNESIUM (NDA filed 2001)
- ESOMEPRAZOLE MAGNESIUM drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2036 — 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.
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