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Last Updated: April 24, 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

US Patents:	0
Tradenames:	7
Applicants:	46
NDAs:	84
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	169
Clinical Trials:	138
Patent Applications:	3,200
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in ranitidine hydrochloride?	ranitidine hydrochloride excipients list
DailyMed Link:	ranitidine hydrochloride at DailyMed

Recent Clinical Trials for ranitidine hydrochloride

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

Sponsor	Phase
Menoufia University	Phase 2/Phase 3
Cairo University	N/A
University of Sao Paulo General Hospital	Phase 3

See all ranitidine hydrochloride clinical trials

Pharmacology for ranitidine hydrochloride

Drug Class	Histamine-2 Receptor Antagonist
Mechanism of Action	Histamine H2 Receptor Antagonists

US Patents and Regulatory Information for ranitidine hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	075296-001	Jan 14, 2000		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Vkt Pharma	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	211289-001	Jan 31, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Perrigo	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	076195-001	Aug 30, 2002		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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	TABLET, EFFERVESCENT;ORAL	020251-001	Mar 31, 1994	⤷ Try a Trial	⤷ Try a Trial
Glaxo Grp Ltd	ZANTAC	ranitidine hydrochloride	SYRUP;ORAL	019675-001	Dec 30, 1988	⤷ Try a Trial	⤷ Try a Trial
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	GRANULE, EFFERVESCENT;ORAL	020251-002	Mar 31, 1994	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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