Ranitidine hydrochloride - Generic Drug Details

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, 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, Akorn, Amneal Pharms, Apotex Inc, 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. Twenty-nine 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:	29
Raw Ingredient (Bulk) Api Vendors:	154
Clinical Trials:	136
Patent Applications:	3,425
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
Cairo University	N/A
University of Sao Paulo General Hospital	Phase 3
Ohio State University Comprehensive Cancer Center	Phase 2/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

Anatomical Therapeutic Chemical (ATC) Classes for ranitidine hydrochloride

A02BA	H2-receptor antagonists
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

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
Ranbaxy	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	SYRUP;ORAL	078448-001	Dec 13, 2007		DISCN	No	No
Aurobindo Pharma	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	207579-001	Nov 13, 2017		DISCN	No	No
Strides Pharma	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	200536-001	Jun 28, 2011		DISCN	No	No
Aurobindo Pharma	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	207578-001	Nov 13, 2017		DISCN	No	No
Amneal Pharms Ny	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	077824-002	Oct 13, 2006		DISCN	No	No
Wockhardt	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	078653-001	Nov 26, 2007		DISCN	No	No

Expired US Patents for ranitidine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	ZANTAC 75	ranitidine hydrochloride	TABLET;ORAL	020520-001	Dec 19, 1995
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	TABLET, EFFERVESCENT;ORAL	020251-001	Mar 31, 1994
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	TABLET;ORAL	018703-001	Jun 9, 1983
Glaxo Grp Ltd	ZANTAC	ranitidine hydrochloride	SYRUP;ORAL	019675-001	Dec 30, 1988
Pai Holdings Pharm	ZANTAC	ranitidine hydrochloride	INJECTABLE;INJECTION	019090-001	Oct 19, 1984
Glaxosmithkline	ZANTAC 150	ranitidine hydrochloride	CAPSULE;ORAL	020095-001	Mar 8, 1994