Details for New Drug Application (NDA): 211617
✉ Email this page to a colleague
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 five 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: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211617
Generic Entry Date for 211617*:
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: 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: | Feb 21, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 14, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF TREATING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE BY DECREASING THE LEVEL OF LDL-C USING A FIXED DOSE COMBINATION OF 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 19, 2040 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617-001 | Feb 26, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
