Details for New Drug Application (NDA): 211616
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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.
Summary for 211616
Tradename: | NEXLETOL |
Applicant: | Esperion Theraps Inc |
Ingredient: | bempedoic acid |
Patents: | 5 |
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 | 72426-118-09 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-118-09) |
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: | Feb 21, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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 |
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 | ⤷ Subscribe | ⤷ Subscribe |
Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | ⤷ Subscribe | ⤷ Subscribe |
Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | ⤷ Subscribe | ⤷ Subscribe |
Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | ⤷ Subscribe | ⤷ Subscribe |
Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | ⤷ Subscribe | ⤷ Subscribe |
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