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FDA Orange Book · active-ingredient family

Ganaxolone

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

Reference-listed drug:ZTALMY · NDA 215904

1

Brand (NDA)

0

Generics (ANDA)

11

Listed patents

3

Exclusivity periods

Brand (NDA) products · suspension

ProductApplicantApplicationTEApproved
ZTALMYRLDIMMEDICA PHARMANDA 215904—Jun 01, 2022

Marketing exclusivity (3)

  • D-197New indication / change exclusivity (3 years)

    Oct 16, 2028

    in 2 yr 4 mo

  • NCENew chemical entity exclusivity (5 years)

    Jun 01, 2027

    in 1 yr

  • ODE-395Orphan-drug exclusivity (7 years)

    Jun 01, 2029

    in 3 yr

Listed patents (11)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8618087Nov 28, 2026in 5 mo
U-3374
9056116Nov 28, 2026in 5 mo
U-3374
7858609Nov 28, 2026in 5 mo
Product
8022054Nov 28, 2026in 5 mo
Product
8367651Nov 28, 2026in 5 mo
Product
9029355Nov 28, 2026in 5 mo
Product
8318714Nov 28, 2031in 5 yr 6 mo
Product
12144801Aug 10, 2037in 11 yr 4 mo
U-4034
10603308Aug 10, 2037in 11 yr 4 mo
U-3374
12115169Sep 30, 2042in 16 yr 6 mo
U-3374
12268696Sep 30, 2042in 16 yr 6 mo
U-3374

Ganaxolone — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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