FDA Orange Book · active-ingredient family
Ozenoxacin
Ozenoxacin is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:XEPI · NDA 208945
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XEPIRLD | LNHC | NDA 208945 | — | Dec 11, 2017 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9399014 | Dec 15, 2029 | in 3 yr 7 mo | U-805 |
| 9180200 | Jan 29, 2032 | in 5 yr 8 mo | ProductU-805 |
Ozenoxacin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

