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Last Updated: January 29, 2022

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Ranitidine hydrochloride - Generic Drug Details

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What are the generic sources for ranitidine hydrochloride and what is the scope of freedom to operate?

Ranitidine hydrochloride is the generic ingredient in seven branded drugs marketed by Ajanta Pharma Ltd, Appco, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Mylan, Novitium Pharma, Sandoz, Teva, Glaxosmithkline, Glaxo Grp Ltd, Bedford, Hikma, Mylan Labs Ltd, Zydus Pharms Usa Inc, Teligent, Actavis Mid Atlantic, Akorn, Amneal Pharms, Apotex Inc, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Taro, Tolmar, Torrent, Wockhardt, Sanofi Us, Amneal Pharms Ny, Ani Pharms, 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 eighty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-three drug master file entries for ranitidine hydrochloride. Forty-three suppliers are listed for this compound.

Summary for ranitidine hydrochloride
Recent Clinical Trials for ranitidine hydrochloride

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

SponsorPhase
University of Sao Paulo General HospitalPhase 3
Ohio State University Comprehensive Cancer CenterPhase 2/Phase 3
Ain Shams UniversityPhase 4

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
Sun Pharm Inds Ltd RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 075439-001 Apr 19, 2000 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sandoz RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 074467-002 Aug 29, 1997 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sandoz RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 075519-001 Sep 26, 2002 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Ani Pharms RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 074488-001 Jul 31, 1997 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Strides Pharma RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 210010-001 Aug 1, 2018 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ranitidine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Us ZANTAC 75 ranitidine hydrochloride TABLET;ORAL 020520-001 Dec 19, 1995 ⤷  Try it Free ⤷  Try it Free
Glaxo Grp Ltd ZANTAC ranitidine hydrochloride SYRUP;ORAL 019675-001 Dec 30, 1988 ⤷  Try it Free ⤷  Try it Free
Teligent ZANTAC ranitidine hydrochloride INJECTABLE;INJECTION 019090-001 Oct 19, 1984 ⤷  Try it Free ⤷  Try it Free
Teligent ZANTAC IN PLASTIC CONTAINER ranitidine hydrochloride INJECTABLE;INJECTION 019593-002 Sep 27, 1991 ⤷  Try it Free ⤷  Try it Free
Teligent ZANTAC ranitidine hydrochloride INJECTABLE;INJECTION 019090-001 Oct 19, 1984 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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