DRIZALMA SPRINKLE Drug Patent Profile

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

Drizalma Sprinkle is a drug marketed by Sun Pharm and is included in one NDA. There are four 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-nine 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:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	1
Patent Applications:	4,847
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in DRIZALMA SPRINKLE?	DRIZALMA SPRINKLE excipients list
DailyMed Link:	DRIZALMA SPRINKLE at DailyMed

Recent Clinical Trials for DRIZALMA SPRINKLE

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

Sponsor	Phase
Scripps Health	Phase 2

See all DRIZALMA SPRINKLE clinical trials

Pharmacology for DRIZALMA SPRINKLE

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

Anatomical Therapeutic Chemical (ATC) Classes for DRIZALMA SPRINKLE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for DRIZALMA SPRINKLE

DRIZALMA SPRINKLE is protected by four US patents.

Patents protecting 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 Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-001	Jul 19, 2019		DISCN	Yes	No			Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-002	Jul 19, 2019		DISCN	Yes	No			Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-001	Jul 19, 2019		DISCN	Yes	No			Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-003	Jul 19, 2019		DISCN	Yes	No			Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-002	Jul 19, 2019		DISCN	Yes	No			Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-004	Jul 19, 2019		DISCN	Yes	No			Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-004	Jul 19, 2019		DISCN	Yes	No			Y

International Patents for DRIZALMA SPRINKLE

See the table below for patents covering DRIZALMA SPRINKLE around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3335697	ÉCLATS DE DULOXÉTINE (DULOXETINE SPRINKLES)

Supplementary Protection Certificates for DRIZALMA SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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