Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Boehringer Ingelheim
Johnson and Johnson
Medtronic
Baxter

Last Updated: October 1, 2022

CYMBALTA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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-eight 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.

  Try it Free

Drug patent expirations by year for CYMBALTA
Drug Prices for CYMBALTA

See drug prices for CYMBALTA

Drug Sales Revenue Trends for CYMBALTA

See drug sales revenues for CYMBALTA

Recent Clinical Trials for CYMBALTA

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

SponsorPhase
Hawler Medical UniversityPhase 2
University of North Carolina, Chapel HillPhase 4
Rambam Health Care CampusN/A

See all CYMBALTA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CYMBALTA
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

CYMBALTA is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting CYMBALTA

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004 See Plans and Pricing See Plans and Pricing
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004 See Plans and Pricing See Plans and Pricing
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004 See Plans and Pricing See Plans and Pricing
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004 See Plans and Pricing See Plans and Pricing
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CYMBALTA

See the table below for patents covering CYMBALTA around the world.

Country Patent Number Title Estimated Expiration
Canada 2344057 TRAITEMENT DE DOULEUR PERSISTANTE (TREATMENT OF PERSISTENT PAIN) See Plans and Pricing
Japan 2002524513 See Plans and Pricing
Germany 69941712 See Plans and Pricing
Austria 57924 See Plans and Pricing
Australia 746887 See Plans and Pricing
Philippines 26556 3-aryloxy-3-substituted propanamines See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CYMBALTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0693282 PA2005001,C0693282 Lithuania See Plans and Pricing 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 2005C/001 Belgium See Plans and Pricing PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
0273658 C00273658/01 Switzerland See Plans and Pricing PRODUCT: DULOXETIN; REG. NO/DATE: SWISSMEDIC 56727 20041217; DER WIDERRUF VOM 05.03.2009 ERFOLGTE IRRTUEMLICH
0273658 3/2005 Austria See Plans and Pricing PRODUCT NAME: 3-ARYLOXY-3-SUBSTITUIERTE-PROPANAMINE; REGISTRATION NO/DATE: EU/1/04/280/001 - EU/1/04/280/006 20040811
0693282 PA2005001 Lithuania See Plans and Pricing 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 See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Moodys
McKesson
Johnson and Johnson
Colorcon

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 verification 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.