DrugPatentWatch Database Preview

DRIZALMA SPRINKLE Drug Profile

Email this page to a colleague

« Back to Dashboard

Which patents cover Drizalma Sprinkle, and when can generic versions of Drizalma Sprinkle launch?

Drizalma Sprinkle is a drug marketed by Sun Pharma Global and is included in one NDA. There are two patents protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in DRIZALMA SPRINKLE 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Drizalma Sprinkle

A generic version of DRIZALMA SPRINKLE was approved as duloxetine hydrochloride by AUROBINDO PHARMA LTD on December 11^th, 2013.

Summary for DRIZALMA SPRINKLE

International Patents:	1
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in DRIZALMA SPRINKLE?	DRIZALMA SPRINKLE excipients list
DailyMed Link:	DRIZALMA SPRINKLE at DailyMed

Pharmacology for DRIZALMA SPRINKLE

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

ATC Classes for DRIZALMA SPRINKLE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for DRIZALMA SPRINKLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharma Global	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED RELEASE;ORAL	212516-001	Jul 19, 2019		RX	Yes	No			Y
Sun Pharma Global	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED RELEASE;ORAL	212516-004	Jul 19, 2019		RX	Yes	Yes			Y
Sun Pharma Global	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED RELEASE;ORAL	212516-002	Jul 19, 2019		RX	Yes	No			Y
Sun Pharma Global	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED RELEASE;ORAL	212516-004	Jul 19, 2019		RX	Yes	Yes			Y
Sun Pharma Global	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED RELEASE;ORAL	212516-001	Jul 19, 2019		RX	Yes	No			Y
Sun Pharma Global	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED RELEASE;ORAL	212516-002	Jul 19, 2019		RX	Yes	No			Y
Sun Pharma Global	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED RELEASE;ORAL	212516-003	Jul 19, 2019		RX	Yes	No			Y

International Patents for DRIZALMA SPRINKLE

Country	Patent Number	Estimated Expiration
European Patent Office	3335697

Supplementary Protection Certificates for DRIZALMA SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0273658	2005C/001	Belgium		PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
0273658	SPC/GB05/003	United Kingdom		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