bendamustine hydrochloride · Cephalon · NDA 022249
Treanda
Earliest generic entry, as listed · earliest of 2 marketed strengths
26 Apr 2031
Blocked by patent: US 8436190.
Listed patents · 14 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8436190 | — | 26 Apr 2031 |
| US 8436190 | product | 26 Oct 2030 |
| US 8344006 | — | 23 Mar 2030 |
| US 8445524 | — | 26 Sep 2029 |
| US 8669279 | — | 26 Sep 2029 |
| US 8883836 | — | 26 Sep 2029 |
| US 9533955 | — | 26 Sep 2029 |
| US 8344006 | product, use U-1402 | 23 Sep 2029 |
| US 8445524 | substance, product, use U-1402 | 26 Mar 2029 |
| US 8445524 | substance | 26 Mar 2029 |
| US 8669279 | product, use U-1402 | 26 Mar 2029 |
| US 8883836 | product, use U-1402 | 26 Mar 2029 |
| US 9533955 | product, use U-1952 | 26 Mar 2029 |
| US 9533955 | product, use U-1949 | 26 Mar 2029 |
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022249 · 001 · RLD | powder, intravenous | 100MG/VIAL | 26 Apr 2031 |
| 022249 · 002 · RLD | powder, intravenous | 25MG/VIAL | 26 Apr 2031 |
| 022249 · 003 · RLD · discontinued | solution, intravenous | 45MG/0.5ML (90MG/ML) | 23 Mar 2030 |
| 022249 · 004 · RLD · discontinued | solution, intravenous | 180MG/2ML (90MG/ML) | 23 Mar 2030 |
Expired or delisted (6)
- US 8609863 · — · 12 Jul 2026
- US 8791270 · — · 12 Jul 2026
- US 8895756 · — · 12 Jul 2026
- US 8609863 · product · 12 Jan 2026
- US 8791270 · product, use U-1542 · 12 Jan 2026
- US 8895756 · product · 12 Jan 2026