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Generated: May 23, 2017

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Duloxetine hydrochloride - Generic Drug Details

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

Duloxetine hydrochloride
is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Macleods Pharms Ltd, Dr Reddys Labs Ltd, Lilly, Zydus Pharms Usa Inc, Inventia Hlthcare, Zydus Hlthcare, Hetero Labs Ltd Iii, 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 nineteen NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Duloxetine hydrochloride has thirteen patent family members in fourteen countries.

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

Summary for Generic Name: duloxetine hydrochloride

Tradenames:2
Patents:2
Applicants:19
NDAs:19
Drug Master File Entries: see list41
Suppliers / Packagers: see list56
Bulk Api Vendors: see list55
Clinical Trials: see list1,100
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:duloxetine hydrochloride at DailyMed

Pharmacology for Ingredient: duloxetine hydrochloride

Tentative approvals for DULOXETINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► SubscribeEQ 20MG BASECAPSULE, DELAYED RELEASE; ORAL
► Subscribe► SubscribeEQ 60MG BASECAPSULE, DELAYED RELEASE; ORAL
► Subscribe► SubscribeEQ 30MG BASECAPSULE, DELAYED RELEASE; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Anchen Pharms
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090780-003Oct 28, 2015ABRXNoNo► Subscribe► Subscribe
Aurobindo Pharma Ltd
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090778-001Dec 11, 2013ABRXNoNo► Subscribe► Subscribe
Anchen Pharms
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090780-001Oct 28, 2015ABRXNoNo► Subscribe► Subscribe
Lupin Ltd
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090694-001Dec 11, 2013ABRXNoNo► Subscribe► Subscribe
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-001Aug 3, 2004ABRXYesNo► Subscribe► Subscribe
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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 verifification 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.

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