enalapril maleate · Azurity · NDA 204308
Epaned Kit
Earliest generic entry, as listed
6 Nov 2032
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8568747, US 8778366, US 9855214, US 9968553.
Listed patents · 4 unexpired
12 Orange Book listing rows for 4 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8568747 | drug product · sets the listed date | 6 Nov 2032 |
| US 8778366 | use U-1723, U-185, U-1892, U-3, U-71 | 6 Nov 2032 |
| US 8778366 listing row | use U-1723 · sets the listed date | 6 Nov 2032 |
| US 8778366 listing row | use U-185 · sets the listed date | 6 Nov 2032 |
| US 8778366 listing row | use U-1892 · sets the listed date | 6 Nov 2032 |
| US 8778366 listing row | use U-3 · sets the listed date | 6 Nov 2032 |
| US 8778366 listing row | use U-71 · sets the listed date | 6 Nov 2032 |
| US 9855214 | drug product · sets the listed date | 6 Nov 2032 |
| US 9968553 | use U-1723, U-185, U-1892, U-3, U-71 | 6 Nov 2032 |
| US 9968553 listing row | use U-1723 · sets the listed date | 6 Nov 2032 |
| US 9968553 listing row | use U-185 · sets the listed date | 6 Nov 2032 |
| US 9968553 listing row | use U-1892 · sets the listed date | 6 Nov 2032 |
| US 9968553 listing row | use U-3 · sets the listed date | 6 Nov 2032 |
| US 9968553 listing row | use U-71 · sets the listed date | 6 Nov 2032 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 |
|---|---|---|---|
| 204308 · 001 · RLD · discontinued | for solution, oral | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 6 Nov 2032 |