Last Updated: May 14, 2026

AMITRIPTYLINE Drug Patent Profile


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When do Amitriptyline patents expire, and when can generic versions of Amitriptyline launch?

Amitriptyline is a drug marketed by Watson Labs, Accord Hlthcare, Aiping Pharm Inc, Am Therap, Ani Pharms, Aurobindo Pharma Usa, Breckenridge, Copley Pharm, Halsey, Lederle, Mankind Pharma, Mutual Pharm, Par Pharm, Ph Health, Pliva, Purepac Pharm, Rising, Roxane, Rubicon Research, Sandoz, Sun Pharm Inds Inc, Superpharm, Teva, Ucb Inc, Unichem, Unique Pharm, Usl Pharma, Vangard, West Ward, and Zydus Pharms. and is included in one hundred and twenty NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Amitriptyline

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

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US Patents and Regulatory Information for AMITRIPTYLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Pharm AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 088700-001 Sep 25, 1984 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rising AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 217411-005 May 19, 2023 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Halsey AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 085922-001 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
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.