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Last Updated: July 26, 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 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, 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-one 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
Brigham and Women's HospitalPhase 4
Partners in HealthPhase 4
Malawi Ministry of 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
Mutual Pharm AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 085743-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sun Pharm Inds Inc AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 089399-003 Jul 14, 1987 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Roxane AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 086147-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sandoz AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 085968-004 Approved Prior to Jan 1, 1982 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lederle AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 087368-001 May 3, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Watson Labs PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; perphenazine TABLET;ORAL 070373-001 Aug 25, 1986 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Ani Pharms AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 085031-001 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 012703-006 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 012703-005 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 012703-007 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
Baxter
Johnson and Johnson
Moodys
Express Scripts
Mallinckrodt

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