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Last Updated: October 26, 2020

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EZALLOR SPRINKLE Drug 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 suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.

US ANDA 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 29th, 2016.

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Summary for EZALLOR SPRINKLE
Drug patent expirations by year for EZALLOR SPRINKLE
Drug Prices for EZALLOR SPRINKLE

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Pharmacology for EZALLOR SPRINKLE

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   Start Trial   Start Trial Y   Start Trial
Sun Pharma Global EZALLOR SPRINKLE rosuvastatin calcium CAPSULE;ORAL 208647-004 Dec 18, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharma Global EZALLOR SPRINKLE rosuvastatin calcium CAPSULE;ORAL 208647-002 Dec 18, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sun Pharma Global EZALLOR SPRINKLE rosuvastatin calcium CAPSULE;ORAL 208647-003 Dec 18, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for EZALLOR SPRINKLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 92544 Luxembourg   Start Trial 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
0521471 0391023-9 Sweden   Start Trial PRODUCT NAME: ROSUVASTATIN
0521471 0390023-0 Sweden   Start Trial PRODUCT NAME: ROSUVASTATIN
0521471 SPC/GB03/033 United Kingdom   Start Trial 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
0720599 CR 2014 00048 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF ROSUVASTATIN OG EZETIMIBE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER ROSUVASTATIN SOM ZINK; NAT. REG. NO/DATE: 52921, 52922, 52923 20140820; FIRST REG. NO/DATE: NO 13-9663, 13-9664, 13-9665 20140724
0521471 03C0043 France   Start Trial PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106
0521471 C300125 Netherlands   Start Trial PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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Baxter

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