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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.
Summary for EZALLOR SPRINKLE
| International Patents: | 2 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EZALLOR SPRINKLE |
| DailyMed Link: | EZALLOR SPRINKLE at DailyMed |
Pharmacology for EZALLOR SPRINKLE
| Drug Class | HMG-CoA Reductase Inhibitor |
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
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 |
International Patents for EZALLOR SPRINKLE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2017037740 | Start Trial |
| European Patent Office | 3344242 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
