navepegritide · Ascendis · NDA 219164
Yuviwel
Earliest generic entry, as listed · earliest of 3 marketed strengths
12 Nov 2042
Blocked by patent: US 12377133.
Listed patents · 12 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12377133 | drug product, use U-4425 · sets the listed date | 12 Nov 2042 |
| US 10835578 | drug substance, drug product, use U-4425 | 5 Jan 2037 |
| US 11154593 | drug substance, drug product, use U-4425 | 5 Jan 2037 |
| US 11224661 | drug substance, drug product | 5 Jan 2037 |
| US 11311604 | drug substance, drug product, use U-4425 | 5 Jan 2037 |
| US 11389510 | drug substance, drug product | 5 Jan 2037 |
| US 11389511 | drug product, use U-4425 | 5 Jan 2037 |
| US 11413351 | drug substance, drug product | 5 Jan 2037 |
| US 12083182 | use U-4425 | 5 Jan 2037 |
| US 12156917 | use U-4425 | 5 Jan 2037 |
| US 12239689 | use U-4425 | 5 Jan 2037 |
| US 8906847 | drug substance, drug product, use U-4425 | 30 Apr 2031 |
Exclusivities · 2 unexpired
| ODE-516 | orphan drug (7 years) | 27 Feb 2033 |
| NCE | new chemical entity (5 years) | 27 Feb 2031 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 219164 · 001 · RLD | powder, subcutaneous | 1.3MG/VIAL | 12 Nov 2042 |
| 219164 · 002 · RLD | powder, subcutaneous | 2.8MG/VIAL | 12 Nov 2042 |
| 219164 · 003 · RLD | powder, subcutaneous | 5.5MG/VIAL | 12 Nov 2042 |