bempedoic acid · Esperion Theraps Inc · NDA 211616
Nexletol
Earliest generic entry, as listed
19 Jun 2040
Blocked by patent: US 11613511, US 11760714, US 11926584, US 12398087, US 12404227.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11613511 | drug substance · sets the listed date | 19 Jun 2040 |
| US 11760714 | drug product · sets the listed date | 19 Jun 2040 |
| US 11926584 | use U-3873 · sets the listed date | 19 Jun 2040 |
| US 12398087 | drug substance, drug product · sets the listed date | 19 Jun 2040 |
| US 12404227 | drug substance, use U-4258 · sets the listed date | 19 Jun 2040 |
| US 11744816 | use U-3883 | 14 Mar 2036 |
| US 7335799 | drug substance | 3 Dec 2030 |
Exclusivities · 2 unexpired
| I-943 | new indication (3 years) | 22 Mar 2027 |
| I-944 | new indication (3 years) | 22 Mar 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211616 · 001 · RLD | tablet, oral | 180MG | 19 Jun 2040 |