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Last Updated: March 29, 2024

Ranitidine hydrochloride - Generic Drug Details


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What are the generic drug sources for ranitidine hydrochloride and what is the scope of patent protection?

Ranitidine hydrochloride is the generic ingredient in seven branded drugs marketed by Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Dr Reddys Labs Ltd, Mylan, Novitium Pharma, Sandoz, Teva, Glaxosmithkline, Glaxo Grp Ltd, Bedford, Hikma, Mylan Labs Ltd, Zydus Pharms Usa Inc, Pai Holdings Pharm, Actavis Mid Atlantic, Amneal Pharms, Apotex Inc, Epic Pharma Llc, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Taro, Tolmar, Torrent, Wockhardt, Chattem Sanofi, Amneal Pharms Ny, Ani Pharms, Apotex, Boehringer Ingelheim, Contract Pharmacal, Dr Reddys Labs Inc, Glenmark Pharms Inc, Granules, Heritage Pharma Avet, Par Pharm, Perrigo, Perrigo R And D, Strides Pharma, Sun Pharm Inds Ltd, Thinq Pharm-cro Pvt, 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 thirty-two drug master file entries for ranitidine hydrochloride. Thirteen 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
Menoufia UniversityPhase 2/Phase 3
Cairo UniversityN/A
University of Sao Paulo General HospitalPhase 3

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
Sandoz RANITIDINE HYDROCHLORIDE ranitidine hydrochloride CAPSULE;ORAL 074655-002 Oct 22, 1997 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lannett Co Inc RANITIDINE HYDROCHLORIDE ranitidine hydrochloride SYRUP;ORAL 078890-001 Jul 1, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxo Grp Ltd ZANTAC 150 ranitidine hydrochloride GRANULE, EFFERVESCENT;ORAL 020251-002 Mar 31, 1994 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo R And D RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 091429-002 May 11, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds Ltd RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 075439-001 Apr 19, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pai Holdings Pharm ZANTAC IN PLASTIC CONTAINER ranitidine hydrochloride INJECTABLE;INJECTION 019593-001 Dec 17, 1986 DISCN No No ⤷  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 ranitidine hydrochloride

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