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FDA Orange Book · active-ingredient family

Zoliflodacin

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

Reference-listed drug:NUZOLVENCE · NDA 219491

1

Brand (NDA)

0

Generics (ANDA)

6

Listed patents

2

Exclusivity periods

Brand (NDA) products · for suspension

ProductApplicantApplicationTEApproved
NUZOLVENCERLDENTASIS THERAPNDA 219491—Dec 12, 2025

Marketing exclusivity (2)

  • NCENew chemical entity exclusivity (5 years)

    Dec 12, 2030

    in 4 yr 7 mo

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    Dec 12, 2035

    in 9 yr 7 mo

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9040528Oct 13, 2029in 3 yr 4 mo
U-4369
8658641Jun 20, 2030in 4 yr 1 mo
Substance
9839641Jan 21, 2034in 7 yr 8 mo
U-4369
9540394Jan 21, 2034in 7 yr 8 mo
U-4369
9187495Jan 21, 2034in 7 yr 8 mo
SubstanceU-4369
8889671Jan 21, 2034in 7 yr 8 mo
SubstanceU-4369

Zoliflodacin — 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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