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Rabeprazole sodium - Generic Drug Details

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Rabeprazole sodium is the generic ingredient in three branded drugs marketed by Teva Pharms Usa, Dr Reddys Labs Ltd, Fsc Therap, Breckenridge Pharm, Lupin Ltd, Eisai Inc, Torrent Pharms Ltd, Kremers Urban Dev, Amneal Pharms, and Mylan Pharms Inc, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for rabeprazole sodium. Twenty-two suppliers are listed for this compound.

Summary for Generic Name: rabeprazole sodium

Tradenames:3
Patents:0
Applicants:10
NDAs:10
Drug Master File Entries: see list29
Suppliers / Packaging: see list22
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: rabeprazole sodium

Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors

Clinical Trials for: rabeprazole sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Torrent Pharms Ltd
RABEPRAZOLE SODIUM
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL202376-001Nov 8, 2013RXNo<disabled><disabled>
Mylan Pharms Inc
RABEPRAZOLE SODIUM
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL076885-001Nov 8, 2013RXNo<disabled><disabled>
Fsc Therap
ACIPHEX SPRINKLE
rabeprazole sodium
CAPSULE, DELAYED RELEASE;ORAL204736-002Mar 26, 2013RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: rabeprazole sodium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc
ACIPHEX
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL020973-001May 29, 20025,045,552*PED<disabled>
Eisai Inc
ACIPHEX
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL020973-001May 29, 20025,035,899<disabled>
Fsc Therap
ACIPHEX SPRINKLE
rabeprazole sodium
CAPSULE, DELAYED RELEASE;ORAL204736-001Mar 26, 20135,045,552*PED<disabled>
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