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FDA Orange Book · active-ingredient family

Gepotidacin mesylate

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

Reference-listed drug:BLUJEPA · NDA 218230

1

Brand (NDA)

0

Generics (ANDA)

4

Listed patents

3

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
BLUJEPARLDGLAXOSMITHKLINENDA 218230—Mar 25, 2025

Marketing exclusivity (3)

  • I-978New indication exclusivity (3 years)

    Dec 11, 2028

    in 2 yr 6 mo

  • NCENew chemical entity exclusivity (5 years)

    Mar 25, 2030

    in 3 yr 10 mo

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    Mar 25, 2035

    in 8 yr 11 mo

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8389524Feb 12, 2029in 2 yr 8 mo
SubstanceProductU-4166
10702521Aug 20, 2035in 9 yr 4 mo
U-4361
11229646Aug 20, 2035in 9 yr 4 mo
U-4361
12528809Dec 13, 2042in 16 yr 9 mo
SubstanceProductU-4361

Gepotidacin mesylate — 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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