besifloxacin hydrochloride · Bausch And Lomb · NDA 022308
Besivance
Earliest generic entry, as listed
9 Jan 2031
Blocked by patent: US 8481526.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8481526 | drug substance · sets the listed date | 9 Jan 2031 |
| US 8415342 | use U-80 | 7 Nov 2030 |
| US 8604020 | drug product | 12 Mar 2030 |
| US 8937062 | use U-80 | 13 Nov 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022308 · 001 · RLD | suspension/drops, ophthalmic | EQ 0.6% BASE | 9 Jan 2031 |