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Last Updated: February 25, 2021

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RANITIDINE HYDROCHLORIDE Drug Profile

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Which patents cover Ranitidine Hydrochloride, and what generic alternatives are available?

Ranitidine Hydrochloride is a drug marketed by Ajanta Pharma Ltd, Appco, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Mylan, Novitium Pharma, Sandoz, Teva, Bedford, Mylan Labs Ltd, West-ward Pharms Int, Zydus Pharms Usa Inc, Actavis Mid Atlantic, Akorn, Amneal Pharms, Anda Repository, Apotex Inc, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Taro, Torrent, Wockhardt, Amneal Pharms Ny, Ani Pharms Inc, Apotex, Boehringer Ingelheim, Contract Pharmacal, Dr Reddys Labs Inc, Glenmark Pharms Inc, Granules, Heritage Pharma, Par Pharm, Perrigo, Perrigo R And D, Strides Pharma, Sun Pharm Inds Ltd, Unique Pharm Labs, Vkt Pharma, Watson Labs, and Wockhardt Ltd. and is included in seventy-five NDAs.

The generic ingredient in RANITIDINE HYDROCHLORIDE is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Eighty-seven suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Ranitidine Hydrochloride

A generic version of RANITIDINE HYDROCHLORIDE was approved as ranitidine hydrochloride by SANDOZ on August 29th, 1997.

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Drug patent expirations by year for RANITIDINE HYDROCHLORIDE
Recent Clinical Trials for RANITIDINE HYDROCHLORIDE

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SponsorPhase
University of Sao Paulo General HospitalPhase 3
National Cancer Institute (NCI)Phase 1
City of Hope Medical CenterPhase 1

See all RANITIDINE HYDROCHLORIDE clinical trials

Pharmacology for RANITIDINE HYDROCHLORIDE

US Patents and Regulatory Information for RANITIDINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Pharm RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 075180-001 Jan 28, 1999 AB RX No No   Start Trial   Start Trial   Start Trial
Wockhardt RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 078884-001 Jul 31, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 075296-001 Jan 14, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Pharm Assoc RANITIDINE HYDROCHLORIDE ranitidine hydrochloride SYRUP;ORAL 077405-001 Sep 21, 2007 AA RX No Yes   Start Trial   Start Trial   Start Trial
Strides Pharma RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 205512-001 Aug 22, 2016 DISCN 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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Serving leading biopharmaceutical companies globally:

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Medtronic
Colorcon
McKesson
Merck

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