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Last Updated: June 25, 2021

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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.

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.

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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Phase 4
University of MichiganPhase 4
Columbia UniversityPhase 4

See all CYMBALTA clinical trials

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   Get Started Free   Get Started Free   Get Started Free
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004 AB RX Yes No   Get Started Free   Get Started Free   Get Started Free
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004 AB RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>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 021427-002 Aug 3, 2004   Get Started Free   Get Started Free
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004   Get Started Free   Get Started Free
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004   Get Started Free   Get Started Free
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004   Get Started Free   Get Started Free
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004   Get Started Free   Get Started Free
>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 3/2005 Austria   Get Started Free PRODUCT NAME: 3-ARYLOXY-3-SUBSTITUIERTE-PROPANAMINE; REGISTRATION NO/DATE: EU/1/04/280/001 - EU/1/04/280/006 20040811
0273658 2005C/001 Belgium   Get Started Free PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
0693282 PA2005001,C0693282 Lithuania   Get Started Free 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 SPC/GB05/003 United Kingdom   Get Started Free 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
0273658 C300171 Netherlands   Get Started Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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