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Last Updated: August 8, 2020

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CYMBALTA Drug 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. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has sixteen patent family members in fourteen countries.

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

US ANDA 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
Wake Forest University Health SciencesPhase 4
Alto NeurosciencePhase 4
The Emili Sagol Creative Arts Therapies Research CenterN/A

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Paragraph IV (Patent) Challenges for CYMBALTA
Tradename Dosage Ingredient NDA Submissiondate
CYMBALTA CAPSULE, DELAYED REL PELLETS;ORAL duloxetine hydrochloride 021427 2012-05-10
CYMBALTA CAPSULE, DELAYED REL PELLETS;ORAL duloxetine hydrochloride 021427 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   Start Trial   Start Trial   Start Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
>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 021427-004 Aug 3, 2004   Start Trial   Start Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004   Start Trial   Start Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004   Start Trial   Start Trial
>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 C00273658/01 Switzerland   Start Trial PRODUCT: DULOXETIN; REG. NO/DATE: SWISSMEDIC 56727 20041217; DER WIDERRUF VOM 05.03.2009 ERFOLGTE IRRTUEMLICH
0693282 PA2005001 Lithuania   Start Trial 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   Start Trial 300171, 20071218, EXPIRES: 20121217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
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Colorcon

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