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Serving leading biopharmaceutical companies globally:

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Generated: December 12, 2017

DrugPatentWatch Database Preview

CYMBALTA Drug Profile

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Which patents cover Cymbalta, and what generic alternatives are available?

Cymbalta is a drug marketed by Lilly and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has sixteen patent family members in fourteen countries and three supplementary protection certificates in three countries.

The generic ingredient in CYMBALTA is duloxetine hydrochloride. There are forty-one drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
LillyCYMBALTAduloxetine hydrochlorideCAPSULE, DELAYED REL PELLETS;ORAL021427-001Aug 3, 2004ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
LillyCYMBALTAduloxetine hydrochlorideCAPSULE, DELAYED REL PELLETS;ORAL021427-004Aug 3, 2004ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
LillyCYMBALTAduloxetine hydrochlorideCAPSULE, DELAYED REL PELLETS;ORAL021427-002Aug 3, 2004ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
LillyCYMBALTAduloxetine hydrochlorideCAPSULE, DELAYED REL PELLETS;ORAL021427-004Aug 3, 2004ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
LillyCYMBALTAduloxetine hydrochlorideCAPSULE, DELAYED REL PELLETS;ORAL021427-001Aug 3, 2004ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
LillyCYMBALTAduloxetine hydrochlorideCAPSULE, DELAYED REL PELLETS;ORAL021427-002Aug 3, 2004ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: CYMBALTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
LillyCYMBALTAduloxetine hydrochlorideCAPSULE, DELAYED REL PELLETS;ORAL021427-002Aug 3, 2004► Subscribe► Subscribe
LillyCYMBALTAduloxetine hydrochlorideCAPSULE, DELAYED REL PELLETS;ORAL021427-001Aug 3, 2004► Subscribe► Subscribe
LillyCYMBALTAduloxetine hydrochlorideCAPSULE, DELAYED REL PELLETS;ORAL021427-002Aug 3, 2004► Subscribe► Subscribe
LillyCYMBALTAduloxetine hydrochlorideCAPSULE, DELAYED REL PELLETS;ORAL021427-004Aug 3, 2004► Subscribe► Subscribe
LillyCYMBALTAduloxetine hydrochlorideCAPSULE, DELAYED REL PELLETS;ORAL021427-001Aug 3, 2004► Subscribe► Subscribe
LillyCYMBALTAduloxetine hydrochlorideCAPSULE, DELAYED REL PELLETS;ORAL021427-004Aug 3, 2004► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for CYMBALTA

Drugname Dosage Strength RLD Submissiondate
duloxetine hydrochlorideDelayed-release Capsules40 mgCymbalta5/10/2012
duloxetine hydrochlorideDelayed-release Capsules20 mg, 30 mg and 60 mgCymbalta8/4/2008

International Patent Family for Tradename: CYMBALTA

Country Document Number Estimated Expiration
Japan2002524513► Subscribe
Cyprus1110581► Subscribe
Spain2335067► Subscribe
Canada2344057► Subscribe
Australia1197200► Subscribe
Portugal1113797► Subscribe
Brazil9913671► Subscribe
Slovenia1113797► Subscribe
European Patent Office1113797► Subscribe
Germany69941712► 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: CYMBALTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
05C/001Belgium► SubscribePRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 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
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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Serving leading biopharmaceutical companies globally:

Dow
Farmers Insurance
Daiichi Sankyo
Deloitte
Express Scripts
Chinese Patent Office
Healthtrust
McKinsey
Mallinckrodt
Medtronic

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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