Assyro AI

FDA Orange Book · active-ingredient family

Maribavir

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

Reference-listed drug:LIVTENCITY · NDA 215596

1

Brand (NDA)

0

Generics (ANDA)

7

Listed patents

2

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
LIVTENCITYRLDTAKEDA PHARMS USANDA 215596—Nov 23, 2021

Marketing exclusivity (2)

  • NCENew chemical entity exclusivity (5 years)

    Nov 23, 2026

    in 5 mo

  • ODE-388Orphan-drug exclusivity (7 years)

    Nov 23, 2028

    in 2 yr 6 mo

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12447169Oct 27, 2031in 5 yr 5 mo
U-4329
11684632Jan 04, 2032in 5 yr 8 mo
U-3650
12447170Nov 18, 2042in 16 yr 8 mo
U-4328
12213989Nov 18, 2042in 16 yr 8 mo
U-4137
12433907Nov 18, 2042in 16 yr 8 mo
U-4289
12527771Oct 11, 2043in 17 yr 7 mo
SubstanceProduct
12295940Oct 11, 2043in 17 yr 7 mo
SubstanceProduct

Maribavir — 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.

Book a Demo