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Last Updated: September 21, 2021

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AMITRIPTYLINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Amitriptyline Hydrochloride, and what generic alternatives are available?

Amitriptyline Hydrochloride is a drug marketed by Watson Labs, 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, and Zydus Pharms. and is included in one hundred and sixteen NDAs.

The generic ingredient in AMITRIPTYLINE HYDROCHLORIDE is amitriptyline hydrochloride. There are thirteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Amitriptyline Hydrochloride

A generic version of AMITRIPTYLINE HYDROCHLORIDE was approved as amitriptyline hydrochloride by SUN PHARM INDS INC on July 14th, 1987.

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Drug patent expirations by year for AMITRIPTYLINE HYDROCHLORIDE
Recent Clinical Trials for AMITRIPTYLINE HYDROCHLORIDE

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SponsorPhase
Hospital Israelita Albert EinsteinPhase 4
Industria FarmacĂȘutica Health MedsPhase 4
National Institute of Mental Health (NIMH)Phase 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
Purepac Pharm AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 088085-001 Jul 18, 1983 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sun Pharm Inds Inc AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 040816-003 Jun 27, 2008 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mankind Pharma AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 213999-003 Feb 19, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Lederle AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 086743-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
West Ward AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 087278-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Roxane AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 086147-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Dow
Baxter
Express Scripts
AstraZeneca
Harvard Business School

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