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Last Updated: November 24, 2020

DrugPatentWatch Database Preview

Rabeprazole sodium - Generic Drug Details

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What are the generic drug sources for rabeprazole sodium and what is the scope of patent protection?

Rabeprazole sodium is the generic ingredient in three branded drugs marketed by Aytu, Eisai Inc, 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 twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty drug master file entries for rabeprazole sodium. Twenty-four suppliers are listed for this compound.

Recent Clinical Trials for rabeprazole sodium

Identify potential brand extensions & 505(b)(2) entrants

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
Teva Pharms Usa RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 076822-001 Nov 8, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Rubicon RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 204237-001 Nov 18, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Aytu ACIPHEX SPRINKLE rabeprazole sodium CAPSULE, DELAYED RELEASE;ORAL 204736-001 Mar 26, 2013 RX Yes 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

Expired US Patents for rabeprazole sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aytu ACIPHEX SPRINKLE rabeprazole sodium CAPSULE, DELAYED RELEASE;ORAL 204736-001 Mar 26, 2013   Start Trial   Start Trial
Eisai Inc ACIPHEX rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 020973-001 May 29, 2002   Start Trial   Start Trial
Eisai Inc ACIPHEX rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 020973-002 Aug 19, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Colorcon
Medtronic
Baxter
McKesson
Harvard Business School

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