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FDA Orange Book · active-ingredient family

Remibrutinib

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

Reference-listed drug:RHAPSIDO · NDA 218436

1

Brand (NDA)

0

Generics (ANDA)

3

Listed patents

1

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
RHAPSIDORLDNOVARTISNDA 218436—Sep 30, 2025

Marketing exclusivity (1)

  • NCENew chemical entity exclusivity (5 years)

    Sep 30, 2030

    in 4 yr 4 mo

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10457647Nov 13, 2034in 8 yr 6 mo
U-4280
9512084Nov 13, 2034in 8 yr 6 mo
SubstanceProduct
12419889Jan 19, 2043in 16 yr 10 mo
U-4281

Remibrutinib — 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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