.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Duloxetine hydrochloride - Generic Drug Details

« Back to Dashboard
Duloxetine hydrochloride is the generic ingredient in two branded drugs marketed by Dr Reddys Labs Ltd, Lilly, Zydus Pharms Usa Inc, Inventia 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 seventeen 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-one 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:16
NDAs:17
Drug Master File Entries: see list41
Suppliers / Packaging: see list51
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Drug Prices:see low prices

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
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090783-001Dec 11, 2013RXNo► subscribe► subscribe
Teva Pharms Usa
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090783-002Dec 11, 2013RXNo► subscribe► subscribe
Anchen Pharms
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090780-003Oct 28, 2015RXNo► subscribe► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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;ORAL021427-002Aug 3, 20045,508,276*PED► subscribe
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-004Aug 3, 20045,508,276*PED► subscribe
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-002Aug 3, 20045,023,269*PED► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: duloxetine hydrochloride

Country Document Number Estimated Expiration
Canada2344057► subscribe
Cyprus1110581► subscribe
China1149991► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: DULOXETINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.

`abc