bendamustine hydrochloride · Eagle Pharms · NDA 205580
Belrapzo
Earliest generic entry, as listed
11 Aug 2031
Blocked by patent: US 8609707.
Listed patents · 10 unexpired
18 Orange Book listing rows for 10 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8609707 | drug product, use U-1971, U-1972 | 11 Aug 2031 |
| US 8609707 listing row | drug product, use U-1971 · sets the listed date | 11 Aug 2031 |
| US 8609707 listing row | drug product, use U-1972 · sets the listed date | 11 Aug 2031 |
| US 10010533 | drug product | 28 Jan 2031 |
| US 11103483 | drug product, use U-1971, U-1972 | 28 Jan 2031 |
| US 11103483 listing row | drug product, use U-1971 | 28 Jan 2031 |
| US 11103483 listing row | drug product, use U-1972 | 28 Jan 2031 |
| US 11844783 | use U-1542, U-1971, U-1972 | 28 Jan 2031 |
| US 11844783 listing row | use U-1542 | 28 Jan 2031 |
| US 11844783 listing row | use U-1971 | 28 Jan 2031 |
| US 11844783 listing row | use U-1972 | 28 Jan 2031 |
| US 11872214 | drug product | 28 Jan 2031 |
| US 12138248 | drug product | 28 Jan 2031 |
| US 12350257 | drug product, use U-1542, U-1971, U-1972 | 28 Jan 2031 |
| US 12350257 listing row | drug product, use U-1542 | 28 Jan 2031 |
| US 12350257 listing row | drug product, use U-1971 | 28 Jan 2031 |
| US 12350257 listing row | drug product, use U-1972 | 28 Jan 2031 |
| US 9265831 | drug product | 28 Jan 2031 |
| US 9572796 | drug product, use U-1971, U-1972 | 28 Jan 2031 |
| US 9572796 listing row | drug product, use U-1971 | 28 Jan 2031 |
| US 9572796 listing row | drug product, use U-1972 | 28 Jan 2031 |
| US 9572797 | use U-1971, U-1972 | 28 Jan 2031 |
| US 9572797 listing row | use U-1971 | 28 Jan 2031 |
| US 9572797 listing row | use U-1972 | 28 Jan 2031 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205580 · 001 · RLD | solution, intravenous | 100MG/4ML (25MG/ML) | 11 Aug 2031 |
Expired or delisted (2)
- US 8791270 · product, use U-1971 · 12 Jan 2026
- US 8791270 · product, use U-1972 · 12 Jan 2026