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CYMBALTA Drug Profile

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

This drug has thirteen patent family members in fourteen countries.

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

Summary for Tradename: CYMBALTA

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list18

Clinical Trials for: CYMBALTA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-001Aug 3, 2004RXNo6,596,756*PED<disabled>Y<disabled>
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-002Aug 3, 2004RXNo<disabled><disabled>
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-001Aug 3, 2004RXNo<disabled><disabled>
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Expired Patents for Tradename: CYMBALTA

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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;ORAL021427-001Aug 3, 20045,023,269*PED<disabled>
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-002Aug 3, 20045,508,276*PED<disabled>
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Paragraph IV activity 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
Germany69941712<disabled in preview>
Portugal1113797<disabled in preview>
Japan2002524513<disabled in preview>
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Supplementary Protection Certificates for Tradename: CYMBALTA

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
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
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
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