CYMBALTA Drug Patent Profile

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 11^th, 2013.

Summary for CYMBALTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	147
Patent Applications:	4,502
Drug Prices:	Drug price information for CYMBALTA
Drug Sales Revenues:	Drug sales revenues for CYMBALTA
What excipients (inactive ingredients) are in CYMBALTA?	CYMBALTA excipients list
DailyMed Link:	CYMBALTA at DailyMed

See drug prices for CYMBALTA

See drug sales revenues for CYMBALTA

Recent Clinical Trials for CYMBALTA

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

Sponsor	Phase
National Cancer Institute, Egypt	Phase 4
Ain Shams University	Phase 4
Grünenthal GmbH	Phase 3

See all CYMBALTA clinical trials

Pharmacology for CYMBALTA

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

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
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-002	Aug 3, 2004	AB	RX	Yes	No
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-004	Aug 3, 2004	AB	RX	Yes	Yes

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
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-002	Aug 3, 2004
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-002	Aug 3, 2004
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-004	Aug 3, 2004

International Patents for CYMBALTA

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

Country	Patent Number	Title	Estimated Expiration
Portugal	693282
Canada	2153856	PASTILLES DE DULOXETINE A DELITAGE ENTERAL (DULOXETINE ENTERIC PELLETS)
China	1316904
Brazil	9503346

Supplementary Protection Certificates for CYMBALTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0273658	3/2005	Austria		PRODUCT NAME: 3-ARYLOXY-3-SUBSTITUIERTE-PROPANAMINE; REGISTRATION NO/DATE: EU/1/04/280/001 - EU/1/04/280/006 20040811
0273658	C00273658/01	Switzerland		PRODUCT: DULOXETIN; REG. NO/DATE: SWISSMEDIC 56727 20041217; DER WIDERRUF VOM 05.03.2009 ERFOLGTE IRRTUEMLICH
0273658	C300171	Netherlands		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
0693282	PA2005001,C0693282	Lithuania		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