Details for New Drug Application (NDA): 211617

NDA 211617 describes NEXLIZET, which is a drug marketed by Esperion Theraps Inc and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the NEXLIZET profile page.

The generic ingredient in NEXLIZET is bempedoic acid; ezetimibe. One supplier is listed for this compound. Additional details are available on the bempedoic acid; ezetimibe profile page.

Summary for 211617

Tradename:	NEXLIZET
Applicant:	Esperion Theraps Inc
Ingredient:	bempedoic acid; ezetimibe
Patents:	8

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 211617

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 NDA: 211617

Mechanism of Action	Adenosine Triphosphate-Citrate Lyase Inhibitors
Physiological Effect	Decreased Cholesterol Absorption

Suppliers and Packaging for NDA: 211617

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617	NDA	Esperion Therapeutics, Inc.	72426-818	72426-818-03	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-818-03)
NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617	NDA	Esperion Therapeutics, Inc.	72426-818	72426-818-99	7 TABLET, FILM COATED in 1 BLISTER PACK (72426-818-99)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	180MG;10MG
Approval Date:	Feb 26, 2020	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Mar 22, 2027
Regulatory Exclusivity Use:	EXPANDED INDICATION FOR USE AS AN ADJUNCT TO DIET, ALONE OR IN COMBINATION WITH OTHER LDL-C LOWERING THERAPIES, TO REDUCE LDL-C IN ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH)
Regulatory Exclusivity Expiration:	Feb 21, 2025
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	Mar 22, 2027
Regulatory Exclusivity Use:	TO REDUCE THE RISK OF MYOCARDIAL INFARCTION AND CORONARY REVASCULARIZATION IN ADULTS WHO ARE UNABLE TO TAKE RECOMMENDED STATIN THERAPY (INCLUDING THOSE NOT TAKING A STATIN) WITH ESTABLISHED CARDIOVASCULAR DISEASE (CVD), OR AT HIGH RISK FOR A CVD EVENT BUT WITHOUT ESTABLISHED CVD

Expired US Patents for NDA 211617

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020

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