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 Pharms Ltd, Hikma, Ivax Sub Teva Pharms, L Perrigo Co, Mylan, Novitium Pharma, Perrigo, Pliva, Sandoz Inc, Teva, Upsher Smith Labs, Watson Labs Inc, Watson Labs Teva, Medtech Products, Dava Pharms Inc, Hospira, Luitpold, Teva Parenteral, Vintage Pharms Llc, Akorn, Ani Pharms, Chartwell Molecular, G And W Labs 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:	30
NDAs:	55
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	161
Clinical Trials:	59
Patent Applications:	6,405
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

See drug prices for cimetidine

Recent Clinical Trials for cimetidine

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

Sponsor	Phase
National Institutes of Health (NIH)	Early Phase 1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Early Phase 1
Washington State University	Early Phase 1

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
Teva	CIMETIDINE	cimetidine	TABLET;ORAL	074151-003	May 17, 1994	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Ivax Sub Teva Pharms	CIMETIDINE	cimetidine	TABLET;ORAL	074424-002	Jul 28, 1995		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Mylan	CIMETIDINE	cimetidine	TABLET;ORAL	074246-004	May 17, 1994	AB	RX	No	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Chartwell Rx	CIMETIDINE	cimetidine	TABLET;ORAL	074100-004	Jan 31, 1995		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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	See Plans and Pricing	See Plans and Pricing
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-005	Apr 30, 1986	See Plans and Pricing	See Plans and Pricing
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-002	Approved Prior to Jan 1, 1982	See Plans and Pricing	See Plans and Pricing
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-003	Approved Prior to Jan 1, 1982	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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