Details for New Drug Application (NDA): 211617
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NDA 211617 describes NEXLIZET, which is a drug marketed by Esperion Theraps Inc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the NEXLIZET profile page.
The generic ingredient in NEXLIZET is bempedoic acid; ezetimibe. One supplier is listed for this compound. Additional details are available on the bempedoic acid; ezetimibe profile page.
The generic ingredient in NEXLIZET is bempedoic acid; ezetimibe. One supplier is listed for this compound. Additional details are available on the bempedoic acid; ezetimibe profile page.
Summary for 211617
| Tradename: | NEXLIZET |
| Applicant: | Esperion Theraps Inc |
| Ingredient: | bempedoic acid; ezetimibe |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211617
*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: 211617
| Mechanism of Action | Adenosine Triphosphate-Citrate Lyase Inhibitors |
| Physiological Effect | Decreased Cholesterol Absorption |
Suppliers and Packaging for NDA: 211617
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617 | NDA | Esperion Therapeutics, Inc. | 72426-818 | 72426-818-03 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-818-03) |
| NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617 | NDA | Esperion Therapeutics, Inc. | 72426-818 | 72426-818-09 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-818-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 180MG;10MG | ||||
| Approval Date: | Feb 26, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 22, 2027 | ||||||||
| Regulatory Exclusivity Use: | EXPANDED INDICATION FOR USE AS AN ADJUNCT TO DIET, ALONE OR IN COMBINATION WITH OTHER LDL-C LOWERING THERAPIES, 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 211617
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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