Last Updated: June 12, 2026

DULOXETINE Drug Patent Profile


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

Duloxetine is a drug marketed by Actavis Elizabeth, Adaptis, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Almatica, Apotex, Aurobindo Pharma Ltd, Breckenridge, Cspc Ouyi, Hetero Labs Ltd Iii, Inventia, Lupin, Macleods Pharms Ltd, Ph Health, Prinston Inc, Qingdao Baheal Pharm, Sun Pharm, Sunshine, Teva Pharms Usa, Torrent, Yaopharma Co Ltd, Zydus Hlthcare, and Zydus Pharms. and is included in twenty-four NDAs.

The generic ingredient in DULOXETINE is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Duloxetine

A generic version of DULOXETINE was approved as duloxetine hydrochloride by AUROBINDO PHARMA LTD on December 11th, 2013.

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Summary for DULOXETINE
US Patents:0
Applicants:24
NDAs:24
Drug Prices: Drug price information for DULOXETINE
Drug Sales Revenues: Drug sales revenues for DULOXETINE
What excipients (inactive ingredients) are in DULOXETINE?DULOXETINE excipients list
DailyMed Link:DULOXETINE at DailyMed

US Patents and Regulatory Information for DULOXETINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Hlthcare DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090739-004 Apr 18, 2023 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lupin DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090694-003 Dec 11, 2013 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Cspc Ouyi DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 211310-003 Oct 16, 2018 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Prinston Inc DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 206653-001 May 18, 2017 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sunshine DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212328-003 Feb 11, 2021 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Macleods Pharms Ltd DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 204815-003 Mar 23, 2017 AB RX 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.