Cimetidine hydrochloride - Generic Drug Details

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

Cimetidine hydrochloride is the generic ingredient in four branded drugs marketed by Dava Pharms Inc, Hospira, Luitpold, Teva Parenteral, Vintage Pharms Llc, Glaxosmithkline, Ani Pharms, Chartwell Molecular, Cycle, G And W Labs Inc, Pai Holdings Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for cimetidine hydrochloride. One supplier is listed for this compound.

Summary for cimetidine hydrochloride

US Patents:	0
Tradenames:	4
Applicants:	13
NDAs:	24
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	62
Patent Applications:	1,275
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in cimetidine hydrochloride?	cimetidine hydrochloride excipients list
DailyMed Link:	cimetidine hydrochloride at DailyMed

Recent Clinical Trials for cimetidine hydrochloride

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

Sponsor	Phase
Assiut University	Early Phase 1
Beijing Biostar Pharmaceuticals Co., Ltd.	Phase 2
Peking University	Phase 2

See all cimetidine hydrochloride clinical trials

Pharmacology for cimetidine hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for cimetidine 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 cimetidine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cycle	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	SOLUTION;ORAL	074541-001	Aug 5, 1997		DISCN	No	No
Chartwell Molecular	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	SOLUTION;ORAL	074251-001	Dec 22, 1994		DISCN	No	No
Teva Parenteral	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	INJECTABLE;INJECTION	074252-001	Nov 26, 1997		DISCN	No	No
Hospira	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	INJECTABLE;INJECTION	074422-001	Jan 31, 1995		DISCN	No	No
Hospira	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	INJECTABLE;INJECTION	074345-001	Jan 31, 1995		DISCN	No	No

Expired US Patents for cimetidine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	INJECTABLE;INJECTION	019434-001	Oct 31, 1985
Glaxosmithkline	TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	INJECTABLE;INJECTION	019434-001	Oct 31, 1985
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	INJECTABLE;INJECTION	017939-002	Approved Prior to Jan 1, 1982
Glaxosmithkline	TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	INJECTABLE;INJECTION	019434-001	Oct 31, 1985
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	SOLUTION;ORAL	017924-001	Approved Prior to Jan 1, 1982