ROSZET Drug Patent Profile

Which patents cover Roszet, and what generic alternatives are available?

Roszet is a drug marketed by Althera Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has ten patent family members in nine countries.

The generic ingredient in ROSZET is ezetimibe; rosuvastatin calcium. There are twenty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ezetimibe; rosuvastatin calcium profile page.

DrugPatentWatch^® Generic Entry Outlook for Roszet

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 1, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ROSZET

International Patents:	10
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in ROSZET?	ROSZET excipients list
DailyMed Link:	ROSZET at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for ROSZET

NDA:

213072

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.

Pharmacology for ROSZET

Drug Class	Dietary Cholesterol Absorption Inhibitor HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors
Physiological Effect	Decreased Cholesterol Absorption

Anatomical Therapeutic Chemical (ATC) Classes for ROSZET

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 ROSZET

ROSZET is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ROSZET

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

International Patents for ROSZET

When does loss-of-exclusivity occur for ROSZET?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Denmark

European Patent Office

Hungary

Mexico

Poland

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ROSZET around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2802252
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)
Portugal	2844233
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.)
Hungary	E052300
Poland	2844233
Denmark	2844233

Supplementary Protection Certificates for ROSZET

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