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FDA Orange Book · active-ingredient family

Aficamten

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

Reference-listed drug:MYQORZO · NDA 219083

1

Brand (NDA)

0

Generics (ANDA)

2

Listed patents

4

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
MYQORZORLD×4CYTOKINETICSNDA 219083—Dec 19, 2025

Marketing exclusivity (4)

  • NCENew chemical entity exclusivity (5 years)

    Dec 19, 2030

    in 4 yr 7 mo

  • NCENew chemical entity exclusivity (5 years)

    Dec 19, 2030

    in 4 yr 7 mo

  • NCENew chemical entity exclusivity (5 years)

    Dec 19, 2030

    in 4 yr 7 mo

  • NCENew chemical entity exclusivity (5 years)

    Dec 19, 2030

    in 4 yr 7 mo

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10836755Jan 18, 2039in 12 yr 9 mo
SubstanceProductU-4371
12370179Jul 15, 2042in 16 yr 4 mo
U-4371

Aficamten — 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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