Ezetimibe; rosuvastatin calcium - Generic Drug Details

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

Dosage:

TABLET;ORAL

^*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
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4

See all ezetimibe; rosuvastatin calcium clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ezetimibe; rosuvastatin calcium

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

C10AX	Other lipid modifying agents
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

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	213072-003	Mar 23, 2021		DISCN	Yes	No			Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-004	Mar 23, 2021		DISCN	Yes	No			Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-001	Mar 23, 2021		DISCN	Yes	No			Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-002	Mar 23, 2021		DISCN	Yes	No			Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-002	Mar 23, 2021		DISCN	Yes	No			Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-001	Mar 23, 2021		DISCN	Yes	No			Y

International Patents for ezetimibe; rosuvastatin calcium

Country	Patent Number	Title	Estimated Expiration
Poland	2844233
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.)
Spain	2802252
Mexico	2014013241	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.)
Denmark	2844233
European Patent Office	2844233	FORMULATION DE COMPRIMÉ ORAL CONSTITUÉE D'UNE COMBINAISON FIXE DE ROSUVASTATINE ET D'ÉZÉTIMIBE POUR LE TRAITEMENT DE L'HYPERLIPIDÉMIE ET DE MALADIES CARDIOVASCULAIRES (ORAL TABLET FORMULATION CONSISTING OF FIXED COMBINATION OF ROSUVASTATIN AND EZETIMIBE FOR TREATMENT OF HYPERLIPIDEMIA AND CARDIOVASCULAR DISEASES)

Supplementary Protection Certificates for ezetimibe; rosuvastatin calcium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	03C0028	France		PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
0720599	05C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402