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Last Updated: January 27, 2023

Duloxetine hydrochloride - Generic Drug Details


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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 Pharms Ltd, 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: 112
Clinical Trials: 347
Patent Applications: 1,004
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
Westfälische Wilhelms-Universität MünsterPhase 4
Dr. Inge WinterPhase 4
Scripps HealthPhase 2

See all duloxetine hydrochloride clinical trials

Generic filers with tentative approvals for DULOXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 60MG BASECAPSULE, DELAYED RELEASE; ORAL
See Plans and PricingSee Plans and PricingEQ 30MG BASECAPSULE, DELAYED RELEASE; ORAL
See Plans and PricingSee Plans and PricingEQ 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.

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
Alembic Pharms Ltd DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 202949-001 Jun 9, 2014 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin Ltd DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090694-004 Dec 11, 2013 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hetero Labs Ltd Iii DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 204343-001 Aug 3, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Anchen Pharms DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090780-001 Oct 28, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004 See Plans and Pricing See Plans and Pricing
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004 See Plans and Pricing See Plans and Pricing
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004 See Plans and Pricing See Plans and Pricing
>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 2005C/001 Belgium See Plans and Pricing PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
0273658 SPC/GB05/003 United Kingdom See Plans and Pricing 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 See Plans and Pricing 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

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