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Last Updated: December 3, 2022

Amitriptyline hydrochloride - Generic Drug Details


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What are the generic drug sources for amitriptyline hydrochloride and what is the scope of freedom to operate?

Amitriptyline hydrochloride is the generic ingredient in eighteen branded drugs marketed by Roche, Watson Labs, Astrazeneca, Bristol Myers Squibb, Warner Chilcott, Accord Hlthcare, Am Therap, Ani Pharms, Aurobindo Pharma Usa, Copley Pharm, Halsey, Leading, Lederle, Mankind Pharma, Mutual Pharm, Par Pharm, Pliva, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Inc, Superpharm, Teva, Ucb Inc, Unichem, Upsher Smith Labs, Usl Pharma, Vangard, Vintage Pharms, West Ward, Zydus Pharms, Heritage Pharma, Micro Labs, Mylan Pharms Inc, Strides Pharma, United Res Labs, Heritage Pharms Inc, Schering, Fosun Pharma, Ivax Sub Teva Pharms, Mylan, Sun Pharm Industries, and New River, and is included in one hundred and seventy-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for amitriptyline hydrochloride. Thirty-three suppliers are listed for this compound.

Summary for amitriptyline hydrochloride
Recent Clinical Trials for amitriptyline hydrochloride

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

SponsorPhase
AlgoTherapeutixPhase 2
Bhupesh Parashar, MDPhase 2
Assiut UniversityN/A

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Pharmacology for amitriptyline hydrochloride
Medical Subject Heading (MeSH) Categories for amitriptyline hydrochloride

US Patents and Regulatory Information for amitriptyline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 071297-001 Dec 10, 1986 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Unichem AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 214548-006 May 19, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Schering ETRAFON-A amitriptyline hydrochloride; perphenazine TABLET;ORAL 014713-002 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lederle AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 086745-001 Approved Prior to Jan 1, 1982 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 amitriptyline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-007 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Astrazeneca ELAVIL amitriptyline hydrochloride INJECTABLE;INJECTION 012704-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-004 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-006 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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Serving leading biopharmaceutical companies globally:

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Harvard Business School
Express Scripts
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Boehringer Ingelheim

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