Ezetimibe; rosuvastatin calcium - Generic Drug Details
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What are the generic drug sources for ezetimibe; rosuvastatin calcium and what is the scope of freedom to operate?
Ezetimibe; rosuvastatin calcium
is the generic ingredient in one branded drug marketed by Althera Pharms and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ezetimibe; rosuvastatin calcium has eleven patent family members in ten countries.
Summary for ezetimibe; rosuvastatin calcium
| International Patents: | 11 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 2 |
| DailyMed Link: | ezetimibe; rosuvastatin calcium at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ezetimibe; rosuvastatin calcium
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ezetimibe; rosuvastatin calcium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Samsung Medical Center | Phase 4 |
| Federal University of São Paulo | Phase 4 |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ezetimibe; rosuvastatin calcium
US Patents and Regulatory Information for ezetimibe; rosuvastatin calcium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Althera Pharms | ROSZET | ezetimibe; rosuvastatin calcium | TABLET;ORAL | 213072-004 | Mar 23, 2021 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Althera Pharms | ROSZET | ezetimibe; rosuvastatin calcium | TABLET;ORAL | 213072-001 | Mar 23, 2021 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Althera Pharms | ROSZET | ezetimibe; rosuvastatin calcium | TABLET;ORAL | 213072-003 | Mar 23, 2021 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 ezetimibe; rosuvastatin calcium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 365046 | FORMULACION DE TABLETA ORAL QUE CONSISTE DE UNA COMBINACION FIJA DE ROSUVASTATINA Y EZETIMIBA PARA EL TRATAMIENTO DE HIPERLIPIDEMIA Y ENFERMEDADES CARDIOVASCULARES. (ORAL TABLET FORMULATION CONSISTING OF FIXED COMBINATION OF ROSUVASTATIN AND EZETIMIBE FOR TREATMENT OF HYPERLIPIDEMIA AND CARDIOVASCULAR DISEASES.) | ⤷ Sign Up |
| Portugal | 2844233 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2013166117 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ezetimibe; rosuvastatin calcium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0720599 | 03C0028 | France | ⤷ Sign Up | PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017 |
| 0720599 | 05C0040 | France | ⤷ Sign Up | PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
