Pantoprazole Sodium generics — when can they launch?
Pantoprazole Sodium (Pantoprazole Sodium) · Pfizer · 2 active US patents · 0 expired
Where Pantoprazole Sodium sits in the generic timeline
All listed Orange Book patents for Pantoprazole Sodium have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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 — 1 patent
- Other — 1 patent
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Pantoprazole Sodium drug page →
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This patent protects multiparticulate formulations of pantoprazole sodium that minimize sticking to medical tubes.USPTO title: Pantoprazole multiparticulate formulations
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This patent protects multiparticulate formulations of pantoprazole sodium that minimize sticking to nasogastric and gastronomy tubes.USPTO title: Pantoprazole multiparticulate formulations
Sources
- FDA Orange Book — patents listed against Pantoprazole Sodium (NDA filed 2000)
- Pantoprazole Sodium drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer patent portfolio
- Patent cliff 2026 — 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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