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FDA Orange Book · active-ingredient family

Finafloxacin

Finafloxacin is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:XTORO · NDA 206307

1

Brand (NDA)

0

Generics (ANDA)

4

Listed patents

0

Exclusivity periods

Brand (NDA) products · suspension/drops

ProductApplicantApplicationTEApproved
XTORORLDFONSECA BIOSCIENCESNDA 206307Dec 17, 2014

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9119859Jul 02, 2030in 4 yr 1 mo
U-1679
9993483Jul 02, 2030in 4 yr 1 mo
Product
8536167Aug 08, 2031in 5 yr 3 mo
U-1679
9504691Nov 21, 2033in 7 yr 6 mo
ProductU-1679

Finafloxacin — 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.