You’re using a public version of DrugPatentWatch with 1 free search available | Register to unlock more free searches. CREATE FREE ACCOUNT

Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
Harvard Business School
McKesson
AstraZeneca
Baxter

Last Updated: February 22, 2024

Duloxetine hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for duloxetine hydrochloride and what is the scope of freedom to operate?

Duloxetine hydrochloride is the generic ingredient in three branded drugs marketed by Lilly, Sun Pharm, Actavis Elizabeth, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Anchen Pharms, Apotex, Aurobindo Pharma Ltd, Breckenridge, Cspc Ouyi, Hetero Labs Ltd Iii, Inventia, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Prinston Inc, Qingdao Baheal Pharm, Sunshine, Teva Pharms Usa, Torrent, Yaopharma Co Ltd, Zydus Hlthcare, and Zydus Pharms, and is included in twenty-five NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Duloxetine hydrochloride has one patent family member in one country.

There are forty drug master file entries for duloxetine hydrochloride. Forty-eight suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for duloxetine hydrochloride
International Patents:1
US Patents:4
Tradenames:3
Applicants:24
NDAs:25
Drug Master File Entries: 40
Finished Product Suppliers / Packagers: 48
Raw Ingredient (Bulk) Api Vendors: 118
Clinical Trials: 354
Patent Applications: 677
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in duloxetine hydrochloride?duloxetine hydrochloride excipients list
DailyMed Link:duloxetine hydrochloride at DailyMed
Recent Clinical Trials for duloxetine hydrochloride

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

SponsorPhase
Grünenthal GmbHPhase 3
Institut Cancerologie de l'OuestPhase 3
Westfälische Wilhelms-Universität MünsterPhase 4

See all duloxetine hydrochloride clinical trials

Generic filers with tentative approvals for DULOXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 60MG BASECAPSULE, DELAYED RELEASE; ORAL
⤷  Try a Trial⤷  Try a TrialEQ 30MG BASECAPSULE, DELAYED RELEASE; ORAL
⤷  Try a Trial⤷  Try a TrialEQ 20MG BASECAPSULE, DELAYED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for duloxetine hydrochloride
Medical Subject Heading (MeSH) Categories for duloxetine hydrochloride
Paragraph IV (Patent) Challenges for DULOXETINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CYMBALTA Delayed-release Capsules duloxetine hydrochloride 40 mg 021427 1 2012-05-10
CYMBALTA Delayed-release Capsules duloxetine hydrochloride 20 mg, 30 mg and 60 mg 021427 16 2008-08-04

US Patents and Regulatory Information for duloxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkem Labs Ltd DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 203197-003 Aug 26, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Breckenridge DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 203088-001 Jun 11, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090783-001 Dec 11, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 duloxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004 ⤷  Try a Trial ⤷  Try a Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004 ⤷  Try a Trial ⤷  Try a Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for duloxetine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0273658 SPC/GB05/003 United Kingdom ⤷  Try a Trial PRODUCT NAME: DULOXETINE AND PHARMACUETICALLY ACCEPTABLE ACID ADDITION SALTS THEREOF, AND IN PARTICULAR DULOXETINE HYDROCHLORIDE; REGISTERED: UK EU/1/04/280/001 20040811; UK EU/1/04/280/002 20040811; UK EU/1/04/280/003 20040811; UK EU/1/04/280/004 20040811; UK EU/1/04/280/005 20040811; UK EU/1/04/280/006 20040811
0273658 2005C/001 Belgium ⤷  Try a Trial PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
0273658 C300171 Netherlands ⤷  Try a Trial PRODUCT NAME: DULOXETINE EN FARMACEUTISCH AANVAARDBARE ZUURADDITIEZOUTEN DAARVAN, EN IN HET BIJZONDER DULOXETINE HYDROCHLORIDE; NATL REGISTRATION NO/DATE: EU/1/04/280/001-006 20040811
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Mallinckrodt
Dow
Johnson and Johnson
Merck

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. 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.