Details for New Drug Application (NDA): 211616
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NDA 211616 describes NEXLETOL, which is a drug marketed by Esperion Theraps Inc and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the NEXLETOL profile page.
The generic ingredient in NEXLETOL is bempedoic acid. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the bempedoic acid profile page.
The generic ingredient in NEXLETOL is bempedoic acid. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the bempedoic acid profile page.
Summary for 211616
| Tradename: | NEXLETOL |
| Applicant: | Esperion Theraps Inc |
| Ingredient: | bempedoic acid |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211616
Generic Entry Date for 211616*:
Constraining patent/regulatory exclusivity:
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 NDA: 211616
| Mechanism of Action | Adenosine Triphosphate-Citrate Lyase Inhibitors |
Suppliers and Packaging for NDA: 211616
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEXLETOL | bempedoic acid | TABLET;ORAL | 211616 | NDA | Esperion Therapeutics, Inc. | 72426-118 | 72426-118-03 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-118-03) |
| NEXLETOL | bempedoic acid | TABLET;ORAL | 211616 | NDA | Esperion Therapeutics, Inc. | 72426-118 | 72426-118-99 | 7 TABLET, FILM COATED in 1 BLISTER PACK (72426-118-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 180MG | ||||
| Approval Date: | Feb 21, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 22, 2027 | ||||||||
| Regulatory Exclusivity Use: | EXPANDED INDICATION FOR USE AS AN ADJUNCT TO DIET, IN COMBINATION WITH OTHER LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) LOWERING THERAPIES, OR ALONE WHEN CONCOMITANT LDL-C LOWERING THERAPY IS NOT POSSIBLE, TO REDUCE LDL-C IN ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH) | ||||||||
| Regulatory Exclusivity Expiration: | Mar 22, 2027 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE THE RISK OF MYOCARDIAL INFARCTION AND CORONARY REVASCULARIZATION IN ADULTS WHO ARE UNABLE TO TAKE RECOMMENDED STATIN THERAPY (INCLUDING THOSE NOT TAKING A STATIN) WITH ESTABLISHED CARDIOVASCULAR DISEASE (CVD), OR AT HIGH RISK FOR A CVD EVENT BUT WITHOUT ESTABLISHED CVD | ||||||||
| Patent: | 11,613,511 | Patent Expiration: | Jun 19, 2040 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Expired US Patents for NDA 211616
| 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 | 9,624,152 | ⤷ Start Trial |
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | 10,118,881 | ⤷ Start Trial |
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | 9,000,041 | ⤷ Start Trial |
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | 8,497,301 | ⤷ Start Trial |
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | 10,941,095 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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