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Last Updated: July 21, 2024

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, Aiping Pharm Inc, Am Therap, Ani Pharms, Aurobindo Pharma Usa, Chemistry Hlth, Copley Pharm, Halsey, Lederle, Mankind Pharma, Mutual Pharm, Par Pharm, Pliva, Purepac Pharm, Rising, Roxane, Rubicon, Sandoz, Sun Pharm Inds Inc, Superpharm, Teva, Ucb Inc, Unichem, Usl Pharma, Vangard, Vintage Pharms, West Ward, Zydus Pharms, Anda Repository, Chartwell Rx, Heritage Pharma, Micro Labs, Mylan Pharms Inc, Schering, Fosun Pharma, Ivax Sub Teva Pharms, Mylan, Sun Pharm Industries, and New River, and is included in one hundred and seventy-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for amitriptyline hydrochloride. Forty-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
Children's Hospital Medical Center, CincinnatiN/A
Patient-Centered Outcomes Research InstituteN/A
Bahria UniversityPhase 4

See all amitriptyline hydrochloride clinical trials

Pharmacology for amitriptyline hydrochloride
Medical Subject Heading (MeSH) Categories for amitriptyline hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes 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
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 217411-004 May 19, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 086853-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; perphenazine TABLET;ORAL 072135-001 Feb 15, 1989 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx LIMBITROL DS amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 016949-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb AMITID amitriptyline hydrochloride TABLET;ORAL 086454-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-006 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Astrazeneca ELAVIL amitriptyline hydrochloride INJECTABLE;INJECTION 012704-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-007 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-003 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-004 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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