NEXLIZET Drug Patent Profile

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

Nexlizet is a drug marketed by Esperion Theraps Inc and is included in one NDA. There are seven patents protecting this drug.

This drug has forty-eight patent family members in twenty-three countries.

The generic ingredient in NEXLIZET is bempedoic acid; ezetimibe. Additional details are available on the bempedoic acid; ezetimibe profile page.

DrugPatentWatch^® Generic Entry Outlook for Nexlizet

Nexlizet will be eligible for patent challenges on February 21, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 3, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for NEXLIZET

International Patents:	48
US Patents:	7
Applicants:	1
NDAs:	1
Clinical Trials:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NEXLIZET
What excipients (inactive ingredients) are in NEXLIZET?	NEXLIZET excipients list
DailyMed Link:	NEXLIZET at DailyMed

See drug prices for NEXLIZET

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for NEXLIZET

NDA:

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.

Recent Clinical Trials for NEXLIZET

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Esperion Therapeutics, Inc.	Phase 4
Kaiser Permanente	Phase 4

See all NEXLIZET clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for NEXLIZET

C10AX	Other lipid modifying agents
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

C10BA	Combinations of various lipid modifying agents
C10B	LIPID MODIFYING AGENTS, COMBINATIONS
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for NEXLIZET

NEXLIZET is protected by seven US patents and two FDA Regulatory Exclusivities.

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 NEXLIZET

FDA Regulatory Exclusivity protecting NEXLIZET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes				Y
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes

EU/EMA Drug Approvals for NEXLIZET

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Daiichi Sankyo Europe GmbH	Nustendi	bempedoic acid, ezetimibe	EMEA/H/C/004959 Nustendi is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibealone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin	Authorised	no	no	no	2020-03-27

International Patents for NEXLIZET

When does loss-of-exclusivity occur for NEXLIZET?

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

Australia

Brazil

Canada

Cyprus

Denmark

European Patent Office

Hungary

Japan

Mexico

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 NEXLIZET around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5593303
Mexico	349134	COMPUESTOS DE HIDROXILO Y COMPOSICIONES PARA EL MANEJO DEL COLESTEROL Y USOS RELACIONADOS. (HYDROXYL COMPOUNDS AND COMPOSITIONS FOR CHOLESTEROL MANAGEMENT AND RELATED USES.)
Ukraine	123355	ФІКСОВАНІ КОМБІНАЦІЇ Й СКЛАДИ, ЯКІ МІСТЯТЬ ETC-1002 Й ЕЗЕТИМІБ, І СПОСОБИ ЛІКУВАННЯ АБО ЗМЕНШЕННЯ РИЗИКУ РОЗВИТКУ СЕРЦЕВО-СУДИННОГО ЗАХВОРЮВАННЯ (FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE AND METHODS OF TREATING OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE)
Singapore	10201908500U	FIXED DOSE COMBINATIONS AND FORMULATIONS COMPRISING ETC1002 AND EZETIMIBE AND METHODS OF TREATING OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE

Supplementary Protection Certificates for NEXLIZET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2404890	640	Finland
2404890	132020000000112	Italy		PRODUCT NAME: ACIDO BEMPEDOICO, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IDRATO, SOLVATO, O LORO MISCELA(NUSTENDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1424, 20200331
2404890	20C1041	France		PRODUCT NAME: ACIDE BEMPEDOIQUE, OU UN SEL, HYDRATE, PRODUIT DE SOLVATATION OU MELANGE DE CEUX-CI, PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/20/1424 20200331
2404890	C20200030 00306	Estonia		PRODUCT NAME: BEMPEEDHAPE;REG NO/DATE: EU/1/20/1424 31.03.2020