bendamustine hydrochloride · Apotex · NDA 211530, 215033, 216078
Bendamustine Hydrochloride
Earliest generic entry, as listed · earliest of 2 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211530 · 001 · RLD · discontinued | solution, intravenous | 25MG/ML (25MG/ML) | open |
| 211530 · 002 · RLD · discontinued | solution, intravenous | 100MG/4ML (25MG/ML) | open |
| 211530 · 003 · RLD · discontinued | solution, intravenous | 200MG/8ML (25MG/ML) | open |
| 215033 · 001 · RLD | solution, intravenous | 100MG/4ML (25MG/ML) | open |
| 216078 · 001 · RLD | solution, intravenous | 100MG/4ML (25MG/ML) | open |