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FDA Orange Book · active-ingredient family

Fitusiran sodium

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

Reference-listed drug:QFITLIA · NDA 219019

1

Brand (NDA)

0

Generics (ANDA)

3

Listed patents

6

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
QFITLIARLD×2GENZYME CORPNDA 219019—Mar 28, 2025

Marketing exclusivity (6)

  • NCENew chemical entity exclusivity (5 years)

    Mar 28, 2030

    in 3 yr 10 mo

  • ODE-510Orphan-drug exclusivity (7 years)

    Mar 28, 2032

    in 5 yr 10 mo

  • ODE-511Orphan-drug exclusivity (7 years)

    Mar 28, 2032

    in 5 yr 10 mo

  • NCENew chemical entity exclusivity (5 years)

    Mar 28, 2030

    in 3 yr 10 mo

  • ODE-510Orphan-drug exclusivity (7 years)

    Mar 28, 2032

    in 5 yr 10 mo

  • ODE-511Orphan-drug exclusivity (7 years)

    Mar 28, 2032

    in 5 yr 10 mo

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9376680Mar 15, 2033in 6 yr 10 mo
SubstanceProductU-4165
9127274Mar 22, 2033in 6 yr 10 mo
SubstanceProductU-4165
11091759Dec 07, 2036in 10 yr 7 mo
U-4165

Fitusiran sodium — 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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