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Last Updated: December 8, 2024

CYMBALTA Drug Patent Profile


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When do Cymbalta patents expire, and what generic alternatives are available?

Cymbalta is a drug marketed by Lilly and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Cymbalta

A generic version of CYMBALTA was approved as duloxetine hydrochloride by AUROBINDO PHARMA LTD on December 11th, 2013.

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Drug patent expirations by year for CYMBALTA
Drug Prices for CYMBALTA

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Drug Sales Revenue Trends for CYMBALTA

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Recent Clinical Trials for CYMBALTA

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SponsorPhase
National Cancer Institute, EgyptPhase 4
Ain Shams UniversityPhase 4
GrĂ¼nenthal GmbHPhase 3

See all CYMBALTA clinical trials

Paragraph IV (Patent) Challenges for CYMBALTA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CYMBALTA Delayed-release Capsules duloxetine hydrochloride 40 mg 021427 1 2012-05-10
CYMBALTA Delayed-release Capsules duloxetine hydrochloride 20 mg, 30 mg and 60 mg 021427 16 2008-08-04

US Patents and Regulatory Information for CYMBALTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CYMBALTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004 ⤷  Sign Up ⤷  Sign Up
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004 ⤷  Sign Up ⤷  Sign Up
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004 ⤷  Sign Up ⤷  Sign Up
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004 ⤷  Sign Up ⤷  Sign Up
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CYMBALTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0273658 C300171 Netherlands ⤷  Sign Up 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
0273658 C00273658/01 Switzerland ⤷  Sign Up PRODUCT: DULOXETIN; REG. NO/DATE: SWISSMEDIC 56727 20041217; DER WIDERRUF VOM 05.03.2009 ERFOLGTE IRRTUEMLICH
0693282 PA2005001,C0693282 Lithuania ⤷  Sign Up PRODUCT NAME: DULOXETINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/04/280/001, EU/1/04/280/002, EU/1/04/280/003, EU/1/04/280/004, EU/1/04/280/005, EU/1/04/280/006 20040811
0273658 300171 Netherlands ⤷  Sign Up 300171, 20071218, EXPIRES: 20121217
0273658 3/2005 Austria ⤷  Sign Up PRODUCT NAME: 3-ARYLOXY-3-SUBSTITUIERTE-PROPANAMINE; REGISTRATION NO/DATE: EU/1/04/280/001 - EU/1/04/280/006 20040811
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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