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NEXLETOL Drug Profile
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» See Plans and PricingWhich 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 five patents protecting this drug.
This drug has twenty-two patent family members in thirteen countries.
The generic ingredient in NEXLETOL is bempedoic acid. Additional details are available on the bempedoic acid profile page.
US ANDA Litigation and Generic Entry Outlook for Nexletol
Nexletol will be eligible for patent challenges on February 21, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
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.
Indicators of Generic Entry
Summary for NEXLETOL
| International Patents: | 22 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Prices: | Drug price information for NEXLETOL |
| DailyMed Link: | NEXLETOL at DailyMed |
Generic Entry Opportunity Date for NEXLETOL
Generic Entry Date for NEXLETOL*:
Constraining patent/regulatory exclusivity:
NDA:
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.
US Patents and Regulatory Information for NEXLETOL
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Esperion Theraps Inc | NEXLETOL | bempedoic acid | TABLET;ORAL | 211616-001 | Feb 21, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for NEXLETOL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | E036646 | Start Trial |
| Japan | 5593303 | Start Trial |
| Mexico | PA05007674 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2004067489 | Start Trial |
| Australia | 2003299993 | Start Trial |
| Brazil | 0318046 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
