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Serving 500+ biopharmaceutical companies globally:

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Generated: June 28, 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, Prinston Inc, 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 twenty 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-five 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:20
NDAs:20
Drug Master File Entries: see list41
Suppliers / Packagers: see list55
Bulk Api Vendors: see list55
Clinical Trials: see list2,463
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
Sun Pharma Global
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090745-002Dec 11, 2013ABRXNoNo► Subscribe► Subscribe
Inventia Hlthcare
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL202336-002Oct 28, 2015ABRXNoNo► Subscribe► Subscribe
Torrent Pharms Ltd
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090774-002Dec 11, 2013ABRXNoNo► Subscribe► Subscribe
Zydus Hlthcare
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090739-001Jan 8, 2014ABRXNoNo► Subscribe► Subscribe
Alembic Pharms Ltd
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL202949-003Jun 9, 2014ABRXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: duloxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-004Aug 3, 20045,508,276*PED► Subscribe
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-001Aug 3, 20045,023,269*PED► Subscribe
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-004Aug 3, 20045,023,269*PED► Subscribe
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-002Aug 3, 20045,023,269*PED► Subscribe
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-001Aug 3, 20045,508,276*PED► Subscribe
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International Patent Family for Ingredient: duloxetine hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)0015223► Subscribe
Germany69941712► Subscribe
Austria449603► Subscribe
Spain2335067► Subscribe
European Patent Office1113797► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DULOXETINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00171Netherlands► SubscribePRODUCT NAME: DULOXETINE EN FARMACEUTISCH AANVAARDBARE ZUURADDITIEZOUTEN DAARVAN, EN IN HET BIJZONDER DULOXETINE HYDROCHLORIDE; NATL REGISTRATION NO/DATE: EU/1/04/280/001-006 20040811
05C/001Belgium► SubscribePRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
C/GB05/003United Kingdom► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Colorcon
Citi
McKinsey
Covington
Federal Trade Commission
Daiichi Sankyo
Farmers Insurance
Baxter
US Department of Justice
Merck

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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