bendamustine hydrochloride · Eagle Pharms · NDA 208194
Bendeka
Blocked by patent: US 10052385, US 9000021, US 9034908, US 9144568, US 9572887, US 9579384, US 9597397, US 9597398, US 9597399. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 19 unexpired
31 Orange Book listing rows for 19 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10052385 | use U-1971, U-1972 | 15 Mar 2033 |
| US 10052385 listing row | use U-1971 · sets the listed date | 15 Mar 2033 |
| US 10052385 listing row | use U-1972 · sets the listed date | 15 Mar 2033 |
| US 9000021 | use U-1542 · sets the listed date | 15 Mar 2033 |
| US 9034908 | use U-1542 · sets the listed date | 15 Mar 2033 |
| US 9144568 | use U-1542 · sets the listed date | 15 Mar 2033 |
| US 9572887 | use U-1971, U-1972 | 15 Mar 2033 |
| US 9572887 listing row | use U-1971 · sets the listed date | 15 Mar 2033 |
| US 9572887 listing row | use U-1972 · sets the listed date | 15 Mar 2033 |
| US 9579384 | use U-1971, U-1972 | 15 Mar 2033 |
| US 9579384 listing row | use U-1971 · sets the listed date | 15 Mar 2033 |
| US 9579384 listing row | use U-1972 · sets the listed date | 15 Mar 2033 |
| US 9597397 | use U-1971, U-1972 | 15 Mar 2033 |
| US 9597397 listing row | use U-1971 · sets the listed date | 15 Mar 2033 |
| US 9597397 listing row | use U-1972 · sets the listed date | 15 Mar 2033 |
| US 9597398 | use U-1971 · sets the listed date | 15 Mar 2033 |
| US 9597399 | use U-1971, U-1972 | 15 Mar 2033 |
| US 9597399 listing row | use U-1971 · sets the listed date | 15 Mar 2033 |
| US 9597399 listing row | use U-1972 · sets the listed date | 15 Mar 2033 |
| US 8609707 | drug product, use U-1542 | 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 |
|---|---|---|---|
| 208194 · 001 · RLD | solution, intravenous | 100MG/4ML (25MG/ML) | 15 Mar 2033 |
Expired or delisted (1)
- US 8791270 · product, use U-1790 · 12 Jan 2026