FDA Orange Book
Is there a generic for Besivance?
Besivance contains besifloxacin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Besivance (besifloxacin). The Orange Book shows its last listed patent expires January 9, 2031.
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Besivance products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension/drops, ophthalmic | EQ 0.6% BASE | Marketed (Rx) | None | 0 | None |
NDA 022308, held by BAUSCH AND LOMB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Besivance patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8937062 | November 13, 2029 | Method of use | U-80 | 022308 |
| 8604020 | March 12, 2030 | Drug product | None | 022308 |
| 8415342 | November 7, 2030 | Method of use | U-80 | 022308 |
| 8481526 | January 9, 2031 | Drug substance | None | 022308 |
Besivance NDC codes
Questions
Is there a generic for Besivance?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Besivance (besifloxacin). The Orange Book shows its last listed patent expires January 9, 2031.
What is the generic name for Besivance?
The active ingredient in Besivance is besifloxacin, per the FDA Orange Book.
When does the Besivance patent expire?
The last patent listed for Besivance in the Orange Book expires January 9, 2031. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.