bempedoic acid; ezetimibe · Esperion Theraps Inc · NDA 211617
Nexlizet
Earliest generic entry, as listed
19 Jun 2040
Blocked by patent: US 11613511, US 11760714, US 11926584, US 12398087, US 12404227.
Listed patents · 8 unexpired
10 Orange Book listing rows for 8 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| 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 10912751 | use U-3224, U-3884 | 14 Mar 2036 |
| US 10912751 listing row | use U-3224 | 14 Mar 2036 |
| US 10912751 listing row | use U-3884 | 14 Mar 2036 |
| US 11744816 | use U-3692, U-3883 | 14 Mar 2036 |
| US 11744816 listing row | use U-3692 | 14 Mar 2036 |
| US 11744816 listing row | 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-945 | 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 |
|---|---|---|---|
| 211617 · 001 · RLD | tablet, oral | 180MG;10MG | 19 Jun 2040 |