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Last Updated: October 24, 2021

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AMITRIPTYLINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for amitriptyline hydrochloride and what is the scope of patent protection?

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, Copley Pharm, Halsey, Lederle, Mankind Pharma, Mutual Pharm, Mylan, 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, Frontida Biopharm, Heritage Pharma, Mylan Pharms Inc, Heritage Pharms Inc, Schering, Fosun Pharma, Ivax Sub Teva Pharms, Sun Pharm Industries, and New River, and is included in one hundred and seventy-five NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen 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
Industria FarmacĂȘutica Health MedsPhase 4
Hospital Israelita Albert EinsteinPhase 4
Partners in HealthPhase 4

See all AMITRIPTYLINE HYDROCHLORIDE clinical trials

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
Ivax Sub Teva Pharms PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; perphenazine TABLET;ORAL 070938-001 Sep 11, 1986 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Frontida Biopharm CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 070765-001 Dec 10, 1986 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Roxane AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 086143-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mutual Pharm AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 085627-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mankind Pharma AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 213999-003 Feb 19, 2021 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Roxane AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 086090-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 AMITRIPTYLINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-005 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca ELAVIL amitriptyline hydrochloride INJECTABLE;INJECTION 012704-001 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-003 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-004 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-006 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-001 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Boehringer Ingelheim
Merck
McKesson
Medtronic

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