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Last Updated: November 24, 2020

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RABEPRAZOLE SODIUM Drug Profile

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When do Rabeprazole Sodium patents expire, and what generic alternatives are available?

Rabeprazole Sodium is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Lannett Co Inc, Lupin Ltd, Mylan, Rubicon, Teva Pharms Usa, and Torrent. and is included in ten NDAs.

The generic ingredient in RABEPRAZOLE SODIUM is rabeprazole sodium. There are thirty drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Rabeprazole Sodium

A generic version of RABEPRAZOLE SODIUM was approved as rabeprazole sodium by DR REDDYS on November 8th, 2013.

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Drug patent expirations by year for RABEPRAZOLE SODIUM
Recent Clinical Trials for RABEPRAZOLE SODIUM

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SponsorPhase
Sihuan Pharmaceutical Holdings Group Ltd.Phase 2
Zeria PharmaceuticalPhase 1
Zeria PharmaceuticalPhase 2

See all RABEPRAZOLE SODIUM clinical trials

Pharmacology for RABEPRAZOLE SODIUM
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for RABEPRAZOLE SODIUM
Paragraph IV (Patent) Challenges for RABEPRAZOLE SODIUM
Tradename Dosage Ingredient NDA Submissiondate
ACIPHEX TABLET, DELAYED RELEASE;ORAL rabeprazole sodium 020973

US Patents and Regulatory Information for RABEPRAZOLE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkem Labs Ltd RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 208644-001 Apr 24, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 076885-001 Nov 8, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Dr Reddys RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 076824-001 Nov 8, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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