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Last Updated: December 4, 2022

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.

Drug Prices for cimetidine

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Recent Clinical Trials for cimetidine

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SponsorPhase
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 UniversityEarly Phase 1

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Pharmacology for cimetidine
Medical Subject Heading (MeSH) Categories for cimetidine

US Patents and Regulatory Information for cimetidine

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

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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