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Last Updated: March 28, 2024

Rabeprazole sodium - Generic Drug Details


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What are the generic drug sources for rabeprazole sodium and what is the scope of freedom to operate?

Rabeprazole sodium is the generic ingredient in three branded drugs marketed by Aytu, Woodward, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma, 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 twenty-nine drug master file entries for rabeprazole sodium. Twenty-three suppliers are listed for this compound.

Summary for rabeprazole sodium
Recent Clinical Trials for rabeprazole sodium

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

SponsorPhase
TenNor Therapeutics (Suzhou) LimitedPhase 3
Xuanzhu Biopharmaceutical Co., Ltd.Phase 2
Boehringer IngelheimPhase 1

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

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
Amneal Pharms RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 204179-001 Jul 31, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Woodward ACIPHEX rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 020973-001 May 29, 2002 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aytu ACIPHEX SPRINKLE rabeprazole sodium CAPSULE, DELAYED RELEASE;ORAL 204736-002 Mar 26, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 208644-001 Apr 24, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 076824-001 Nov 8, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 205761-001 Feb 17, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Woodward ACIPHEX rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 020973-002 Aug 19, 1999 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Woodward ACIPHEX rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 020973-002 Aug 19, 1999 ⤷  Try a Trial ⤷  Try a Trial
Aytu ACIPHEX SPRINKLE rabeprazole sodium CAPSULE, DELAYED RELEASE;ORAL 204736-002 Mar 26, 2013 ⤷  Try a Trial ⤷  Try a Trial
Woodward ACIPHEX rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 020973-002 Aug 19, 1999 ⤷  Try a Trial ⤷  Try a Trial
Woodward ACIPHEX rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 020973-001 May 29, 2002 ⤷  Try a Trial ⤷  Try a Trial
Woodward ACIPHEX rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 020973-001 May 29, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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