sirolimus · Aadi · NDA 213312
Fyarro
Earliest generic entry, as listed
28 Oct 2040
Blocked by patent: US 11497737.
Listed patents · 7 unexpired
9 Orange Book listing rows for 7 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11497737 | drug product · sets the listed date | 28 Oct 2040 |
| US 10973806 | use U-3258 | 29 Jun 2036 |
| US 12133844 | use U-4040, U-4041, U-4042 | 29 Jun 2036 |
| US 12133844 listing row | use U-4040 | 29 Jun 2036 |
| US 12133844 listing row | use U-4041 | 29 Jun 2036 |
| US 12133844 listing row | use U-4042 | 29 Jun 2036 |
| US 10705070 | drug product | 5 Mar 2036 |
| US 12061183 | drug product | 5 Mar 2036 |
| US 10206887 | drug product | 15 Apr 2030 |
| US 8911786 | drug product, use U-3259 | 14 Feb 2029 |
Exclusivities · 1 unexpired
| ODE-386 | orphan drug (7 years) | 22 Nov 2028 |
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 |
|---|---|---|---|
| 213312 · 001 · RLD | powder, intravenous | 100MG/VIAL | 28 Oct 2040 |