Is there a generic for Duloxetine hydrochloride?

Yes. The FDA Orange Book lists 23 approved generic (ANDA) applications for Duloxetine hydrochloride, referencing the brand DULOXETINE HYDROCHLORIDE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Duloxetine hydrochloride?

DULOXETINE HYDROCHLORIDE (NDA 219131, ALMATICA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Duloxetine hydrochloride?

The Orange Book lists 5 patents against Duloxetine hydrochloride products, with the earliest listed expiry in 2037. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Duloxetine hydrochloride are approved?

Duloxetine hydrochloride is approved in the following dosage form: capsule, delayed rel pellets.

FDA Orange Book · active-ingredient family

Duloxetine hydrochloride

Duloxetine hydrochloride is approved as 3 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DULOXETINE HYDROCHLORIDE · NDA 219131

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, delayed rel pellets

Product	Applicant	Application	TE	Approved
DULOXETINE HYDROCHLORIDERLD×3	ALMATICA	NDA 219131	—	Feb 27, 2026
DRIZALMA SPRINKLERLD×4	SUN PHARM	NDA 212516	—	Jul 19, 2019
CYMBALTARLD×3	LILLY	NDA 021427	—	Aug 03, 2004

Generic (ANDA) products (23)

Product	Applicant	Application	TE	Approved
DULOXETINE HYDROCHLORIDE×3	SUNSHINE	ANDA 212328	AB	Feb 11, 2021
DULOXETINE HYDROCHLORIDE×3	YAOPHARMA CO LTD	ANDA 207219	—	Aug 16, 2019
DULOXETINE HYDROCHLORIDE×3	QINGDAO BAHEAL PHARM	ANDA 210599	AB	Apr 17, 2019
DULOXETINE HYDROCHLORIDE×3	CSPC OUYI	ANDA 211310	AB	Oct 16, 2018
DULOXETINE HYDROCHLORIDE×3	PRINSTON INC	ANDA 206653	AB	May 18, 2017
DULOXETINE HYDROCHLORIDE×3	MACLEODS PHARMS LTD	ANDA 204815	AB	Mar 23, 2017
DULOXETINE HYDROCHLORIDE×4	AJANTA PHARMA LTD	ANDA 208706	AB	Jan 06, 2017
DULOXETINE HYDROCHLORIDE×3	HETERO LABS LTD III	ANDA 204343	AB	Aug 03, 2016
DULOXETINE HYDROCHLORIDE×3	INVENTIA	ANDA 202336	AB	Oct 28, 2015
DULOXETINE HYDROCHLORIDE×3	PH HEALTH	ANDA 090780	—	Oct 28, 2015
DULOXETINE HYDROCHLORIDE×3	ALKEM LABS LTD	ANDA 203197	AB	Aug 26, 2015
DULOXETINE HYDROCHLORIDE×3	APOTEX	ANDA 202045	—	Jun 11, 2014
DULOXETINE HYDROCHLORIDE×4	BRECKENRIDGE	ANDA 203088	AB	Jun 11, 2014
DULOXETINE HYDROCHLORIDE×3	ALEMBIC	ANDA 202949	AB	Jun 09, 2014
DULOXETINE HYDROCHLORIDE×4	ZYDUS HLTHCARE	ANDA 090739	AB	Jan 08, 2014
DULOXETINE HYDROCHLORIDE×3	ZYDUS PHARMS	ANDA 090728	AB	Jan 08, 2014
DULOXETINE HYDROCHLORIDE×3	ACTAVIS ELIZABETH	ANDA 090776	AB	Dec 17, 2013
DULOXETINE HYDROCHLORIDE×3	ADAPTIS	ANDA 090723	—	Dec 11, 2013
DULOXETINE HYDROCHLORIDE×3	AUROBINDO PHARMA LTD	ANDA 090778	AB	Dec 11, 2013
DULOXETINE HYDROCHLORIDE×4	LUPIN	ANDA 090694	AB	Dec 11, 2013
DULOXETINE HYDROCHLORIDE×3	SUN PHARM	ANDA 090745	—	Dec 11, 2013
DULOXETINE HYDROCHLORIDE×3	TEVA PHARMS USA	ANDA 090783	—	Dec 11, 2013
DULOXETINE HYDROCHLORIDE×3	TORRENT	ANDA 090774	—	Dec 11, 2013

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9839626	Apr 13, 2037	in 11 yr	Product
10413525	Apr 13, 2037	in 11 yr	Product
12171742	Apr 13, 2037	in 11 yr	Product
11202772	Apr 13, 2037	in 11 yr	Product
10959982	Apr 13, 2037	in 11 yr	Product

Duloxetine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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