Details for New Drug Application (NDA): 213072

NDA 213072 describes ROSZET, which is a drug marketed by Althera Pharms and is included in one NDA. There are two patents protecting this drug. Additional details are available on the ROSZET profile page.

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

Summary for 213072

Tradename:	ROSZET
Applicant:	Althera Pharms
Ingredient:	ezetimibe; rosuvastatin calcium
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 213072

Constraining patent/regulatory exclusivity:

10,376,470

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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG;EQ 5MG BASE
Approval Date:	Mar 23, 2021	TE:		RLD:	Yes
Patent:	10,376,470	Patent Expiration:	May 1, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF HYPERLIPIDEMIA
Patent:	9,763,885	Patent Expiration:	May 1, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF HYPERLIPIDEMIA

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG;EQ 10MG BASE
Approval Date:	Mar 23, 2021	TE:		RLD:	Yes
Patent:	10,376,470	Patent Expiration:	May 1, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF HYPERLIPIDEMIA

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