bortezomib · Hospira · NDA 205004, 206927, 209191, 212782, 215331, 215441
Bortezomib
Earliest generic entry, as listed · earliest of 3 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 4 unexpired
6 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 11679119 | use U-3632, U-3633 | 23 Sep 2042 |
| US 11679119 listing row | use U-3632 | 23 Sep 2042 |
| US 11679119 listing row | use U-3633 | 23 Sep 2042 |
| US 11752164 | use U-3632, U-3633 | 23 Sep 2042 |
| US 11752164 listing row | use U-3632 | 23 Sep 2042 |
| US 11752164 listing row | use U-3633 | 23 Sep 2042 |
| US 12005069 | drug product | 23 Sep 2042 |
| US 8962572 | drug product | 3 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
- First generic approved · ANDA 219167, Gland · 209191-001Approved 6 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219167, Gland · 209191-001Approved 6 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 9
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205004 · 001 · discontinued | powder, intravenous | 3.5MG/VIAL | 3 Nov 2032 |
| 206927 · 001 · discontinued | powder, intravenous | 3.5MG/VIAL | open |
| 209191 · 001 · RLD | powder, intravenous, subcutaneous | 1MG/VIAL | open |
| 209191 · 002 · RLD | powder, intravenous, subcutaneous | 2.5MG/VIAL | open |
| 212782 · 001 · RLD | solution, intravenous, subcutaneous | 3.5MG/1.4ML (2.5MG/ML) | open |
| 215331 · 001 · RLD · discontinued | solution, intravenous | 3.5MG/3.5ML (1MG/ML) | 23 Sep 2042 |
| 215331 · 002 · RLD · discontinued | solution, intravenous | 3.5MG/1.4ML (2.5MG/ML) | 23 Sep 2042 |
| 215441 · 001 · RLD · discontinued | solution, intravenous | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 215441 · 002 · RLD · discontinued | solution, intravenous | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |