NEXLETOL Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Nexletol, and what generic alternatives are available?
Nexletol is a drug marketed by Esperion Theraps Inc and is included in one NDA. There are six patents protecting this drug.
This drug has twenty-three patent family members in thirteen countries.
The generic ingredient in NEXLETOL is bempedoic acid. Additional details are available on the bempedoic acid profile page.
DrugPatentWatch® Generic Entry Outlook for Nexletol
Nexletol 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 NEXLETOL
International Patents: | 23 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 54 |
Patent Applications: | 95 |
Drug Prices: | Drug price information for NEXLETOL |
What excipients (inactive ingredients) are in NEXLETOL? | NEXLETOL excipients list |
DailyMed Link: | NEXLETOL at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity Date for NEXLETOL
Generic Entry Date for NEXLETOL*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Anatomical Therapeutic Chemical (ATC) Classes for NEXLETOL
US Patents and Regulatory Information for NEXLETOL
NEXLETOL is protected by six US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NEXLETOL is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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 NEXLETOL
Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NEXLETOL AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NEXLETOL AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NEXLETOL AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NEXLETOL AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NEXLETOL AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY FOR INHIBITING CHOLESTEROL SYNTHESIS TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
FDA Regulatory Exclusivity protecting NEXLETOL
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
International Patents for NEXLETOL
When does loss-of-exclusivity occur for NEXLETOL?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 03299993
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 18046
Estimated Expiration: See Plans and Pricing
Patent: 0318046
Estimated Expiration: See Plans and Pricing
Canada
Patent: 13660
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 19404
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 04890
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 97223
Estimated Expiration: See Plans and Pricing
Patent: 02300
Estimated Expiration: See Plans and Pricing
Patent: 04890
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 36646
Estimated Expiration: See Plans and Pricing
Patent: 000033
Estimated Expiration: See Plans and Pricing
Japan
Patent: 31349
Estimated Expiration: See Plans and Pricing
Patent: 93303
Estimated Expiration: See Plans and Pricing
Patent: 06513251
Estimated Expiration: See Plans and Pricing
Patent: 12097105
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 05007674
Estimated Expiration: See Plans and Pricing
Patent: 9134
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 04890
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 04890
Estimated Expiration: See Plans and Pricing
Spain
Patent: 94340
Estimated Expiration: See Plans and Pricing
Patent: 25429
Estimated Expiration: See Plans and Pricing
Patent: 42216
Estimated Expiration: See Plans and Pricing
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 NEXLETOL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2402300 | Composés d'hydroxyle et compositions pour gestion du cholestérol et utilisations associées (Hydroxyl compounds and compositions for cholesterol management and related uses) | See Plans and Pricing |
Denmark | 2404890 | See Plans and Pricing | |
European Patent Office | 2404890 | Composés hydroxyle et compositions pour la gestion du cholestérol et utilisations associées (Hydroxyl compounds and compositions for cholesterol management and related uses) | See Plans and Pricing |
Spain | 2642216 | See Plans and Pricing | |
Japan | 4931349 | See Plans and Pricing | |
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) | See Plans and Pricing |
Portugal | 2404890 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEXLETOL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2404890 | 20C1041 | France | See Plans and Pricing | 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 | 640 | Finland | See Plans and Pricing | |
2404890 | 2020C/534 | Belgium | See Plans and Pricing | 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 |
2404890 | C202030044 | Spain | See Plans and Pricing | PRODUCT NAME: ACIDO BEMPEDOICO, O UNA SAL FARMACEUTICAMENTE ACEPTABLE, HIDRATO, SOLVATO O MEZCLA DE LOS MISMOS; NATIONAL AUTHORISATION NUMBER: EU/1/20/1424; DATE OF AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1424; DATE OF FIRST AUTHORISATION IN EEA: 20200327 |
2404890 | C 2020 031 | Romania | See Plans and Pricing | PRODUCT NAME: ACID BEMPEDOIC, SAU O SARE, HIDRAT, SOLVAT ACCEPTABILE FARMACEUTIC SAU AMESTECUL ACESTORA; NATIONAL AUTHORISATION NUMBER: EU/1/20/1424; DATE OF NATIONAL AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1424; DATE OF FIRST AUTHORISATION IN EEA: 20200327 |
2404890 | 38/2020 | Austria | See Plans and Pricing | PRODUCT NAME: BEMPEDOINSAEURE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT, SOLVAT ODER EIN GEMISCH DAVON; REGISTRATION NO/DATE: EU/1/20/1424 (MITTEILUNG) 20200331 |
2404890 | 2090035-3 | Sweden | See Plans and Pricing | PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT,HYDRATE,SOLVATE OR MIXTURE THEREOF; REG. NO/DATE: EU/1/20/1424 20200331 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |