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Last Updated: April 20, 2024

CIMETIDINE - Generic Drug Details

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What are the generic drug 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, Dava Pharms Inc, Hospira, Luitpold, Teva Parenteral, Vintage Pharms Llc, 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. Nineteen 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:	19
Raw Ingredient (Bulk) Api Vendors:	177
Clinical Trials:	62
Patent Applications:	6,057
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
Assiut University	Early Phase 1
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Phase 2
Beijing Biostar Pharmaceuticals Co., Ltd.	Phase 2

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
Mylan	CIMETIDINE	cimetidine	TABLET;ORAL	074246-003	May 17, 1994	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	INJECTABLE;INJECTION	074422-001	Jan 31, 1995		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs Teva	CIMETIDINE	cimetidine	TABLET;ORAL	075425-001	Jul 29, 1999		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ivax Sub Teva Pharms	CIMETIDINE	cimetidine	TABLET;ORAL	074424-002	Jul 28, 1995		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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	017920-003	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-003	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-004	Dec 14, 1983	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-002	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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