Cimetidine - Generic Drug Details

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What are the generic sources for cimetidine and what is the scope of freedom to operate?

Cimetidine is the generic ingredient in seven branded drugs marketed by Glaxosmithkline, Apotex, Chartwell Molecules, Chartwell Rx, Contract Pharmacal, Cycle, Hikma, Ivax Sub Teva Pharms, L Perrigo Co, Mylan, Novitium Pharma, Perrigo, Pliva, Sandoz, Teva, Upsher Smith Labs, Watson Labs Inc, Watson Labs Teva, Medtech Products, Cosette, Endo Operations, Hospira, Luitpold, Teva Parenteral, Ani Pharms, Chartwell Molecular, G And W Labs Inc, Pai Holdings Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in fifty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-five drug master file entries for cimetidine. Eighteen suppliers are listed for this compound.

Summary for cimetidine

US Patents:	0
Tradenames:	7
Applicants:	30
NDAs:	55
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	177
Clinical Trials:	65
Patent Applications:	6,543
Drug Prices:	Drug price trends for cimetidine
What excipients (inactive ingredients) are in cimetidine?	cimetidine excipients list
DailyMed Link:	cimetidine at DailyMed

See drug prices for cimetidine

Recent Clinical Trials for cimetidine

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

Sponsor	Phase
University of Washington	Phase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4
Wollo University	Phase 4

See all cimetidine clinical trials

Pharmacology for cimetidine

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

Medical Subject Heading (MeSH) Categories for cimetidine

Anti-Ulcer Agents
Cytochrome P-450 CYP1A2 Inhibitors
Histamine H2 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for cimetidine

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

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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
Chartwell Rx	CIMETIDINE	cimetidine	TABLET;ORAL	074100-003	Jan 31, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	INJECTABLE;INJECTION	074345-001	Jan 31, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	CIMETIDINE	cimetidine	TABLET;ORAL	075122-001	Jun 19, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	SOLUTION;ORAL	074610-001	Sep 26, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pliva	CIMETIDINE	cimetidine	TABLET;ORAL	074566-001	Feb 27, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 cimetidine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-003	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-004	Dec 14, 1983	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-005	Apr 30, 1986	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-005	Apr 30, 1986	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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