You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 5, 2024

BEMPEDOIC ACID - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

What are the generic sources for bempedoic acid and what is the scope of freedom to operate?

Bempedoic acid is the generic ingredient in two branded drugs marketed by Esperion Theraps Inc and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bempedoic acid has forty-four patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for BEMPEDOIC ACID

International Patents:	44
US Patents:	5
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	14
Patent Applications:	169
What excipients (inactive ingredients) are in BEMPEDOIC ACID?	BEMPEDOIC ACID excipients list
DailyMed Link:	BEMPEDOIC ACID at DailyMed

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

Generic Entry Date for BEMPEDOIC ACID^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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 BEMPEDOIC ACID

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

Sponsor	Phase
Priscilla Hsue, MD	Phase 3
Massachusetts General Hospital	Phase 3
University of Utah	Phase 3

See all BEMPEDOIC ACID clinical trials

Pharmacology for BEMPEDOIC ACID

Drug Class	Adenosine Triphosphate-Citrate Lyase Inhibitor
Mechanism of Action	Adenosine Triphosphate-Citrate Lyase Inhibitors

Paragraph IV (Patent) Challenges for BEMPEDOIC ACID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEXLETOL	Tablets	bempedoic acid	180 mg	211616	9	2024-02-21

US Patents and Regulatory Information for BEMPEDOIC ACID

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Try a Trial
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	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Esperion Theraps Inc	NEXLIZET	bempedoic acid; ezetimibe	TABLET;ORAL	211617-001	Feb 26, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for BEMPEDOIC ACID

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020	⤷ Try a Trial	⤷ Try a Trial
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020	⤷ Try a Trial	⤷ Try a Trial
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616-001	Feb 21, 2020	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for BEMPEDOIC ACID

Subscribe to access the full database, or Try a Trial
Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Daiichi Sankyo Europe GmbH	Nilemdo	bempedoic acid	EMEA/H/C/004958 Nilemdo 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 or statin with other lipid-lowering therapies in patients unable to reach LDL C goals with the maximum tolerated dose of a statin (see sections 4.2, 4.3, and 4.4) or,alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.	Authorised	no	no	no	2020-04-01
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for BEMPEDOIC ACID

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
European Patent Office	1597223	COMPOSES HYDROXYLES ET COMPOSITIONS DE REGULATION DU CHOLESTEROL ET UTILISATIONS ASSOCIEES (HYDROXYL COMPOUNDS AND COMPOSITIONS FOR CHOLESTEROL MANAGEMENT AND RELATED USES)	⤷ Try a Trial
Hungary	E036646		⤷ Try a Trial
Mexico	PA05007674	COMPUESTOS DE HIDROXILO Y COMPOSICIONES PARA EL MANEJO DEL COLESTEROL Y USOS RELACIONADOS. (HYDROXYL COMPOUNDS AND COMPOSITIONS FOR CHOLESTEROL MANAGEMENT AND RELATED USES.)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BEMPEDOIC ACID

Subscribe to access the full database, or Try a Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2404890	2090035-3	Sweden	⤷ Try a Trial	PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT,HYDRATE,SOLVATE OR MIXTURE THEREOF; REG. NO/DATE: EU/1/20/1424 20200331
2404890	2020/037	Ireland	⤷ Try a Trial	PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; REGISTRATION NO/DATE: EU/1/20/1424 20200331
2404890	2020C/534	Belgium	⤷ Try a Trial	PRODUCT NAME: ACIDE BEMPEDOIQUE OU UN SEL, HYDRATE, PRODUIT DE SOLVATATION OU MELANGE DE CEUX-CI, PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/20/1424 20200331
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.