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Last Updated: June 25, 2021

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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, Akorn, Ani Pharms Inc, Cycle Pharms Ltd, G And W Labs Inc, 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. Two suppliers are listed for this compound.

Summary for cimetidine hydrochloride
Recent Clinical Trials for cimetidine hydrochloride

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

SponsorPhase
Ohio State University Comprehensive Cancer CenterPhase 2/Phase 3
Esam HamedN/A
Wafaa HamzaN/A

See all cimetidine hydrochloride clinical trials

Pharmacology for cimetidine hydrochloride

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 074468-002 Dec 29, 1994 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Glaxosmithkline TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER cimetidine hydrochloride INJECTABLE;INJECTION 019434-001 Oct 31, 1985 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
Cycle Pharms Ltd CIMETIDINE HYDROCHLORIDE cimetidine hydrochloride SOLUTION;ORAL 074541-001 Aug 5, 1997 DISCN No No   Get Started Free   Get Started Free   Get Started Free
>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 HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER cimetidine hydrochloride INJECTABLE;INJECTION 019434-001 Oct 31, 1985   Get Started Free   Get Started Free
Glaxosmithkline TAGAMET cimetidine hydrochloride SOLUTION;ORAL 017924-001 Approved Prior to Jan 1, 1982   Get Started Free   Get Started Free
Glaxosmithkline TAGAMET cimetidine hydrochloride SOLUTION;ORAL 017924-001 Approved Prior to Jan 1, 1982   Get Started Free   Get Started Free
>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
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Mallinckrodt

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