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Last Updated: August 8, 2020

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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, 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, Sun Pharm, Teva Pharms Usa, Torrent, Yaopharma Co Ltd, Zydus Hlthcare, Zydus Pharms, and Sun Pharma Global, and is included in twenty-four NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Duloxetine hydrochloride has seventeen patent family members in fourteen countries.

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

Summary for duloxetine hydrochloride
Recent Clinical Trials for duloxetine hydrochloride

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

SponsorPhase
Wake Forest University Health SciencesPhase 4
Far Eastern Memorial HospitalPhase 3
Beijing Tiantan HospitalPhase 4

See all duloxetine hydrochloride clinical trials

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

Medical Subject Heading (MeSH) Categories for duloxetine hydrochloride
Paragraph IV (Patent) Challenges for DULOXETINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
CYMBALTA CAPSULE, DELAYED REL PELLETS;ORAL duloxetine hydrochloride 021427 2012-05-10
CYMBALTA CAPSULE, DELAYED REL PELLETS;ORAL duloxetine hydrochloride 021427 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
Ajanta Pharma Ltd DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 208706-004 Mar 11, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090783-003 Dec 11, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 202949-002 Jun 9, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharma Global DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED RELEASE;ORAL 212516-003 Jul 19, 2019 RX Yes No   Start Trial   Start Trial Y   Start 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 021427-004 Aug 3, 2004   Start Trial   Start Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004   Start Trial   Start Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004   Start Trial   Start Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004   Start Trial   Start 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   Start 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 C300171 Netherlands   Start 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
0273658 2005C/001 Belgium   Start Trial 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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Serving leading biopharmaceutical companies globally:

Express Scripts
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McKinsey

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