docetaxel · Zhuhai · NDA 218711
Beizray
Earliest generic entry, as listed · earliest of 2 marketed strengths
16 May 2036
Blocked by patent: US 11419842, US 11419842, US 11419842, US 11419842, US 11419842, US 12090134, US 12090134, US 12090134, US 12090134, US 12090134, US 12090135.
Listed patents · 11 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11419842 | product, use U-946 | 16 May 2036 |
| US 11419842 | product, use U-881 | 16 May 2036 |
| US 11419842 | product, use U-4027 | 16 May 2036 |
| US 11419842 | product, use U-4028 | 16 May 2036 |
| US 11419842 | product, use U-937 | 16 May 2036 |
| US 12090134 | product, use U-881 | 16 May 2036 |
| US 12090134 | product, use U-937 | 16 May 2036 |
| US 12090134 | product, use U-946 | 16 May 2036 |
| US 12090134 | product, use U-4027 | 16 May 2036 |
| US 12090134 | product, use U-4028 | 16 May 2036 |
| US 12090135 | product | 16 May 2036 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 218711 · 001 · RLD | solution, intravenous | 80MG/4ML (20MG/ML) | 16 May 2036 |
| 218711 · 002 · RLD | solution, intravenous | 20MG/ML (20MG/ML) | 16 May 2036 |