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, Contract Pharmacal, Cycle Pharms Ltd, Dava Pharms Inc, Hikma, Ivax Sub Teva Pharms, L Perrigo Co, Mylan, Perrigo, Pliva, Sandoz Inc, Teva, Upsher Smith Labs, Watson Labs Inc, Watson Labs Teva, Yaopharma Co Ltd, Medtech Products, Hospira, Luitpold, Teva Parenteral, Vintage Pharms Llc, Akorn, Ani Pharms Inc, G And W Labs Inc, Lannett Co Inc, Pharm Assoc, and Wockhardt Bio Ag, 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:	29
NDAs:	55
Drug Master File Entries:	25
Suppliers / Packagers:	18
Bulk Api Vendors:	136
Clinical Trials:	56
Patent Applications:	6,379
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for cimetidine
What excipients (inactive ingredients) are in cimetidine?	cimetidine excipients list
DailyMed Link:	cimetidine at DailyMed

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Recent Clinical Trials for cimetidine

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

Sponsor	Phase
Assiut University	N/A
Esam Hamed	N/A
Wafaa Hamza	N/A

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

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
Lannett Co Inc	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	SOLUTION;ORAL	074251-001	Dec 22, 1994		DISCN	No	No	Start Trial	Start Trial				Start Trial
Teva Parenteral	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	INJECTABLE;INJECTION	074252-001	Nov 26, 1997		DISCN	No	No	Start Trial	Start Trial				Start Trial
Watson Labs Inc	CIMETIDINE	cimetidine	TABLET;ORAL	074316-001	Feb 28, 1996		DISCN	No	No	Start Trial	Start Trial				Start Trial
Ani Pharms Inc	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	SOLUTION;ORAL	075110-001	Jun 18, 1998		DISCN	No	No	Start Trial	Start Trial				Start Trial
Ani Pharms Inc	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	SOLUTION;ORAL	074610-001	Sep 26, 1996		DISCN	No	No	Start Trial	Start Trial				Start Trial
Ivax Sub Teva Pharms	CIMETIDINE	cimetidine	TABLET;ORAL	074424-003	Jul 28, 1995		DISCN	No	No	Start Trial	Start Trial				Start 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 cimetidine

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

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