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FDA Orange Book · active-ingredient family

Gepirone hydrochloride

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

Reference-listed drug:EXXUA · NDA 021164

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

4

Exclusivity periods

Brand (NDA) products · tablet, extended release

ProductApplicantApplicationTEApproved
EXXUARLD×4FABRE KRAMERNDA 021164—Sep 22, 2023

Marketing exclusivity (4)

  • NCENew chemical entity exclusivity (5 years)

    Sep 22, 2028

    in 2 yr 4 mo

  • NCENew chemical entity exclusivity (5 years)

    Sep 22, 2028

    in 2 yr 4 mo

  • NCENew chemical entity exclusivity (5 years)

    Sep 22, 2028

    in 2 yr 4 mo

  • NCENew chemical entity exclusivity (5 years)

    Sep 22, 2028

    in 2 yr 4 mo

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7538116Sep 02, 2030in 4 yr 3 mo
U-3699

Gepirone hydrochloride — 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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