NEXLETOL Drug Patent Profile
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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. One supplier is listed for this compound. 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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Patent Applications: | 139 |
| Drug Prices: | Drug price information for NEXLETOL |
| What excipients (inactive ingredients) are in NEXLETOL? | NEXLETOL excipients list |
| DailyMed Link: | NEXLETOL at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Pharmacology for NEXLETOL
| Drug Class | Adenosine Triphosphate-Citrate Lyase Inhibitor |
| Mechanism of Action | Adenosine Triphosphate-Citrate Lyase Inhibitors |
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ 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 | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 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 | ⤷ 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 | ⤷ 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 | ⤷ 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 | ⤷ 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 |
EU/EMA Drug Approvals for NEXLETOL
| 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 NEXLETOL
See the table below for patents covering NEXLETOL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| 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.) | ⤷ Try a Trial |
| Portugal | 2404890 | ⤷ Try a Trial | |
| Brazil | 0318046 | Compostos de hidroxila e composições para controle de colesterol e empregos relacionados | ⤷ Try a Trial |
| 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 |
| World Intellectual Property Organization (WIPO) | 2004067489 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEXLETOL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2404890 | 122020000048 | Germany | ⤷ Try a Trial | PRODUCT NAME: BEMPEDOINSAEURE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT, SOLVAT ODER EIN GEMISCH DAVON; REGISTRATION NO/DATE: EU/1/20/1424 20200327 |
| 2404890 | 38/2020 | Austria | ⤷ Try a Trial | PRODUCT NAME: BEMPEDOINSAEURE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ, HYDRAT, SOLVAT ODER EIN GEMISCH DAVON; REGISTRATION NO/DATE: EU/1/20/1424 (MITTEILUNG) 20200331 |
| 2404890 | SPC/GB20/047 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; REGISTERED: UK PLGB 08265/0039 20200331; UK EU/1/20/1424(FOR NI) 20200331 |
| 2404890 | LUC00174 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, SOLVATE, OR MIXTURE THEREOF; AUTHORISATION NUMBER AND 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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