RANITIDINE HYDROCHLORIDE Drug Patent Profile

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, Hikma, Mylan Labs Ltd, Zydus Pharms Usa Inc, Actavis Mid Atlantic, Akorn, Amneal Pharms, Apotex Inc, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Taro, Tolmar, Torrent, Wockhardt, 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, 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. Thirty-eight suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ranitidine Hydrochloride

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

Summary for RANITIDINE HYDROCHLORIDE

US Patents:	0
Applicants:	42
NDAs:	75
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	135
Patent Applications:	2,194
Formulation / Manufacturing:	see details
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
Par Pharm	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	075180-001	Jan 28, 1999	AB	RX	No	No
Wockhardt	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	078884-001	Jul 31, 2008		DISCN	No	No
Ani Pharms	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	075296-001	Jan 14, 2000		DISCN	No	No
Ranbaxy	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	SYRUP;ORAL	078448-001	Dec 13, 2007		DISCN	No	No
Strides Pharma	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	205512-001	Aug 22, 2016		DISCN	No	No
Apotex Inc	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	200172-001	May 31, 2012		DISCN	No	No
Glenmark Pharms Inc	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	078542-002	Nov 19, 2008	AB	RX	No	No