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FDA Orange Book · active-ingredient family

Besifloxacin hydrochloride

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

Reference-listed drug:BESIVANCE · NDA 022308

1

Brand (NDA)

0

Generics (ANDA)

4

Listed patents

0

Exclusivity periods

Brand (NDA) products · suspension/drops

ProductApplicantApplicationTEApproved
BESIVANCERLDBAUSCH AND LOMBNDA 022308—May 28, 2009

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8937062Nov 13, 2029in 3 yr 5 mo
U-80
8604020Mar 12, 2030in 3 yr 9 mo
Product
8415342Nov 07, 2030in 4 yr 5 mo
U-80
8481526Jan 09, 2031in 4 yr 8 mo
Substance

Besifloxacin hydrochloride — 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.

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