Assyro AI

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

ProductApplicantApplicationTEApproved
XEPIRLDLNHCNDA 208945Dec 11, 2017

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9399014Dec 15, 2029in 3 yr 7 mo
U-805
9180200Jan 29, 2032in 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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.