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Duloxetine hydrochloride - Generic Drug Details

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Duloxetine hydrochloride is the generic ingredient in two branded drugs marketed by Dr Reddys Labs Ltd, Lilly, Zydus Pharms Usa Inc, Inventia Hlthcare, Apotex Inc, Sun Pharma Global, Alembic Pharms Ltd, Torrent Pharms Ltd, Actavis Elizabeth, Aurobindo Pharma Ltd, Anchen Pharms, Teva Pharms Usa, Breckenridge Pharm, Lupin Ltd, and Alkem Labs Ltd, and is included in sixteen NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has thirteen patent family members in fourteen countries.

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

Summary for Generic Name: duloxetine hydrochloride

Tradenames:2
Patents:1
Applicants:15
NDAs:16
Drug Master File Entries: see list41
Suppliers / Packaging: see list52
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for Ingredient: duloxetine hydrochloride

Tentative approvals for DULOXETINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, DELAYED RELEASE; ORALEQ 20MG BASE
<disabled><disabled>CAPSULE, DELAYED RELEASE; ORALEQ 30MG BASE
<disabled><disabled>CAPSULE, DELAYED RELEASE; ORALEQ 60MG BASE

Clinical Trials for: duloxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090694-003Dec 11, 2013RXNo<disabled><disabled>
Dr Reddys Labs Ltd
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090723-002Dec 11, 2013RXNo<disabled><disabled>
Alembic Pharms Ltd
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL202949-001Jun 9, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: duloxetine hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-004Aug 3, 20045,023,269*PED<disabled>
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-004Aug 3, 20045,508,276*PED<disabled>
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-001Aug 3, 20045,508,276*PED<disabled>
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International Patent Family for Ingredient: duloxetine hydrochloride

Country Document Number Estimated Expiration
Slovenia1113797<disabled in preview>
Australia1197200<disabled in preview>
Spain2335067<disabled in preview>
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Supplementary Protection Certificates for Tradename: DULOXETINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
05C/001Belgium<disabled>PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
C/GB05/003United Kingdom<disabled>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
00171Netherlands<disabled>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
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