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EZALLOR SPRINKLE Drug Patent Profile

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Which patents cover Ezallor Sprinkle, and what generic alternatives are available?

Ezallor Sprinkle is a drug marketed by Sun Pharma Global and is included in one NDA. There is one patent protecting this drug.

This drug has two patent family members in two countries.

The generic ingredient in EZALLOR SPRINKLE is rosuvastatin calcium. There are forty-two drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ezallor Sprinkle

A generic version of EZALLOR SPRINKLE was approved as rosuvastatin calcium by WATSON LABS INC on April 29^th, 2016.

Summary for EZALLOR SPRINKLE

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

See drug prices for EZALLOR SPRINKLE

Pharmacology for EZALLOR SPRINKLE

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EZALLOR SPRINKLE

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for EZALLOR 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	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-001	Dec 18, 2018		RX	Yes	No			Y
Sun Pharma Global	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-004	Dec 18, 2018		RX	Yes	Yes			Y
Sun Pharma Global	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-002	Dec 18, 2018		RX	Yes	No			Y
Sun Pharma Global	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-003	Dec 18, 2018		RX	Yes	No			Y

International Patents for EZALLOR SPRINKLE

Country	Patent Number	Estimated Expiration
European Patent Office	3344242
World Intellectual Property Organization (WIPO)	2017037740

Supplementary Protection Certificates for EZALLOR SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0521471	0390023-0	Sweden		PRODUCT NAME: ROSUVASTATIN
0720599	300688	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NATIONAL REGISTRATION NO/DATE: RVG114002-004 20140811; FIRST REGISTRATION: NO 13-9663 - 9665 20140724
0720599	C300688	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724
0521471	SPC/GB03/033	United Kingdom		PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321
0521471	0391023-9	Sweden		PRODUCT NAME: ROSUVASTATIN
0720599	92544	Luxembourg		PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 20140724