rilzabrutinib · Genzyme Corp · NDA 219685
Wayrilz
Earliest generic entry, as listed
20 Feb 2041
Blocked by patent: US 11708370.
Listed patents · 6 unexpired
7 Orange Book listing rows for 6 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11708370 | drug substance · sets the listed date | 20 Feb 2041 |
| US 12178818 | use U-4267 | 13 Oct 2040 |
| US 8940744 | drug substance, drug product, use U-4270 | 6 Sep 2033 |
| US 9266895 | drug substance, drug product, use U-4268 | 6 Sep 2033 |
| US 9994576 | drug substance, drug product, use U-4268, U-4269 | 6 Sep 2033 |
| US 9994576 listing row | drug substance, drug product, use U-4268 | 6 Sep 2033 |
| US 9994576 listing row | drug substance, drug product, use U-4269 | 6 Sep 2033 |
| US 9580427 | drug substance, drug product | 1 Mar 2033 |
Exclusivities · 2 unexpired
| ODE-552 | orphan drug (7 years) | 29 Aug 2032 |
| NCE | new chemical entity (5 years) | 29 Aug 2030 |
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 |
|---|---|---|---|
| 219685 · 001 · RLD | tablet, oral | 400MG | 20 Feb 2041 |