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Last Updated: November 12, 2024

Duloxetine hydrochloride - Generic Drug Details


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What are the generic drug sources for duloxetine hydrochloride and what is the scope of patent protection?

Duloxetine hydrochloride is the generic ingredient in three branded drugs marketed by Lilly, Sun Pharm, Actavis Elizabeth, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Breckenridge, Cspc Ouyi, Endo Operations, 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-nine 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: 49
Raw Ingredient (Bulk) Api Vendors: 118
Clinical Trials: 356
Patent Applications: 677
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
Beni-Suef UniversityPhase 2
National Cancer Institute, EgyptPhase 4
Grünenthal GmbHPhase 3

See all duloxetine hydrochloride clinical trials

Generic filers with tentative approvals for DULOXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 60MG BASECAPSULE, DELAYED RELEASE; ORAL
⤷  Sign Up⤷  Sign UpEQ 30MG BASECAPSULE, DELAYED RELEASE; ORAL
⤷  Sign Up⤷  Sign UpEQ 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
Anatomical Therapeutic Chemical (ATC) Classes 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
Torrent DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090774-001 Dec 11, 2013 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 203197-003 Aug 26, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090745-001 Dec 11, 2013 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lupin Ltd DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090694-003 Dec 11, 2013 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lupin Ltd DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090694-004 Dec 11, 2013 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 021427-004 Aug 3, 2004 ⤷  Sign Up ⤷  Sign Up
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004 ⤷  Sign Up ⤷  Sign Up
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004 ⤷  Sign Up ⤷  Sign Up
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004 ⤷  Sign Up ⤷  Sign Up
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for duloxetine hydrochloride

Country Patent Number Title Estimated Expiration
European Patent Office 3335697 ÉCLATS DE DULOXÉTINE (DULOXETINE SPRINKLES) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for duloxetine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0273658 SPC/GB05/003 United Kingdom ⤷  Sign Up 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 C300171 Netherlands ⤷  Sign Up 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
0273658 2005C/001 Belgium ⤷  Sign Up PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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