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Last Updated: March 29, 2020

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Cimetidine hydrochloride - Generic Drug Details

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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 Inc, Cycle Pharms Ltd, G And W Labs Inc, Hi Tech Pharma, Lannett Co Inc, Pharm Assoc, and Wockhardt Bio Ag, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-five drug master file entries for cimetidine hydrochloride.

Recent Clinical Trials for cimetidine hydrochloride

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

SponsorPhase
Assiut UniversityN/A
Esam HamedN/A
Wafaa HamzaN/A

See all cimetidine hydrochloride clinical trials

Recent Litigation for cimetidine hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
In re: '318 Patent Infringement Litigation2005-06-03
In re: &039318 Patent Infringement Litigation2005-06-03

See all cimetidine hydrochloride litigation

Synonyms for cimetidine hydrochloride
059C302
2-Cyano-1-methyl-3-(2-(((5-methylimidazol-4-yl)methyl)thio)ethyl)guanidine monohydrochloride
70059-30-2
71989-90-7
AC-4278
AKOS015961108
AS-15040
C10H16N6S.HCl
CHEBI:50362
CHEMBL1201051
Cimetex
Cimetidine Hcl
CIMETIDINE HCL IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Cimetidine hydrochloride (TN)
Cimetidine hydrochloride (USP)
Cimetidine hydrochloride [USAN:USP]
Cimetidine hydrochloride [USAN]
Cimetidine hydrochloride in sodium chloride 0.9% in plastic container
Cimetidine hydrochloride, European Pharmacopoeia (EP) Reference Standard, European Pharmacopoeia (EP) Reference Standard
Cimetidine hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Cimetidine hydrochloride, United States Pharmacopeia (USP) Reference Standard
CIMETIDINEHYDROCHLORIDE
D03503
DB-055373
DTXSID10990302
EINECS 274-297-2
EINECS 276-264-8
Endo
FT-0602954
Guanidine, N-cyano-N'-methyl-N''-(2-(((5-methyl-1H-imidazol-4-yl)methyl)thio)ethyl)-,monohydrochloride
Guanidine, N'-cyano-N-methyl-N'-(2-(((5-methyl-1H-imidazol-4-yl)methyl)thio)ethyl)-, monohydrochloride
Guanidine, N''-cyano-N-methyl-N'-(2-(((5-methyl-1H-imidazol-4-yl)methyl)thio)ethyl)-, monohydrochloride
LS-73442
N-Cyano-N'-methyl-N''-(2-(((5-methyl-1H-imidazol-4-yl)methyl)thio)ethyl)guanidine hydrochloride
N-Cyano-N'-methyl-N''-(2-(((5-methyl-1H-imidazol-4-yl)methyl)thio)ethyl)guanidine monohydrochloride
N-Cyano-N'-methyl-N''-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]ethyl]guanidine hydrochloride
N-Cyano-N''-methyl-N'-(2-{[(4-methyl-1H-imidazol-5-yl)methyl]sulfanyl}ethyl)guanidine--hydrogen chloride (1/1)
N737
Q27122038
SCHEMBL11156749
SCHEMBL42142
SCHEMBL42144
TAGAMET HCL IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Tagamet hydrochloride in sodium chloride 0.9% in plastic container
Tagamet Injection
Tagamet Liquid
UNII-WF10491673
W-104570
WF10491673

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
Hospira CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER cimetidine hydrochloride INJECTABLE;INJECTION 074468-004 Dec 29, 1994 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
Pharm Assoc CIMETIDINE HYDROCHLORIDE cimetidine hydrochloride SOLUTION;ORAL 075560-001 Mar 15, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER cimetidine hydrochloride INJECTABLE;INJECTION 074468-005 Dec 29, 1994 DISCN No No   Start Trial   Start Trial   Start Trial
Vintage Pharms Llc CIMETIDINE HYDROCHLORIDE cimetidine hydrochloride INJECTABLE;INJECTION 074005-001 Aug 31, 1994 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 hydrochloride

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

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Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Johnson and Johnson
Colorcon
Merck
Mallinckrodt

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