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 four patents protecting this drug and one Paragraph IV challenge.
This drug has forty-four patent family members in sixteen 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 was eligible for patent challenges on February 21, 2024.
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.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for NEXLETOL
| International Patents: | 44 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Patent Applications: | 91 |
| 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
*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
Paragraph IV (Patent) Challenges for NEXLETOL
| 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 NEXLETOL
NEXLETOL is protected by four US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NEXLETOL is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF LOWERING LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) IN A HUMAN PATIENT IN NEED THEREOF COMPRISING ADMINISTRATION OF BEMPEDOIC ACID ALONE OR IN COMBINATION WITH OTHER LIPID LOWERING THERAPIES
Hydroxyl compounds and compositions for cholesterol management and related uses
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting NEXLETOL
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 NEXLETOL
| 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 | ⤷ Sign Up | ⤷ Sign Up |
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
|---|---|---|---|
| Japan | 2006513251 | ⤷ Sign Up | |
| Japan | 4931349 | ⤷ Sign Up | |
| Cyprus | 1119404 | ⤷ Sign Up | |
| Brazil | 112021025964 | Formas de sal de ácido bempedoico e métodos para uso das mesmas | ⤷ Sign Up |
| Canada | 2513660 | COMPOSES HYDROXYLES ET COMPOSITIONS DE REGULATION DU CHOLESTEROL ET UTILISATIONS ASSOCIEES (HYDROXYL COMPOUNDS AND COMPOSITIONS FOR CHOLESTEROL MANAGEMENT AND RELATED USES) | ⤷ Sign Up |
| Israel | 288909 | שיטות להכנה של חומצה במפדואית ותכשירים המכילים אותה (Methods of making bempedoic acid and compositions of the same) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEXLETOL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2404890 | 2090035-3 | Sweden | ⤷ Sign Up | PRODUCT NAME: BEMPEDOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT,HYDRATE,SOLVATE OR MIXTURE THEREOF; REG. NO/DATE: EU/1/20/1424 20200331 |
| 2404890 | CA 2020 00041 | Denmark | ⤷ Sign Up | PRODUCT NAME: BEMPEDOINSYRE ELLER ET/EN FARMACEUTISK ACCEPTABEL(T) SALT, HYDRAT, SOLVAT ELLER BLANDING DERAF; REG. NO/DATE: EU/1/20/1424 20200331 |
| 2404890 | C02404890/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: BEMPEDOINSAEURE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67583 14.12.2020 |
| 2404890 | C202030044 | Spain | ⤷ Sign Up | 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 | SPC/GB20/047 | United Kingdom | ⤷ Sign Up | 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 | C20200030 00306 | Estonia | ⤷ Sign Up | PRODUCT NAME: BEMPEEDHAPE;REG NO/DATE: EU/1/20/1424 31.03.2020 |
| >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.
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