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Last Updated: March 1, 2021

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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 Inc, Copley Pharm, Halsey, Lederle, Mutual Pharm, Mylan, Par Pharm, Pliva, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Inc, Superpharm, Teva, Ucb Inc, 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-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for amitriptyline hydrochloride. Thirty suppliers are listed for this compound.

Summary for amitriptyline hydrochloride
US Patents:0
Tradenames:18
Applicants:37
NDAs:173
Drug Master File Entries: 13
Suppliers / Packagers: 30
Bulk Api Vendors: 95
Clinical Trials: 104
Patent Applications: 3,285
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in amitriptyline hydrochloride?amitriptyline hydrochloride excipients list
DailyMed Link:amitriptyline hydrochloride at DailyMed
Recent Clinical Trials for amitriptyline hydrochloride

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

SponsorPhase
Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma HastanesiN/A
University of Missouri, Kansas CityPhase 3
Marius HenriksenPhase 3

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
Roxane AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 086148-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 202446-004 Jun 4, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Ucb Inc AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 086335-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Par Pharm PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; perphenazine TABLET;ORAL 070620-001 Sep 11, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
New River TRIAVIL 4-10 amitriptyline hydrochloride; perphenazine TABLET;ORAL 014715-003 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 085031-004 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start 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 INJECTABLE;INJECTION 012704-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-004 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-006 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-005 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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