Assyro AI

Orange Book product · Brand (NDA)

LIVTENCITY

MARIBAVIR

Brand (NDA)NDA 215596RX TAKEDA PHARMS USA

At a glance

Nov 23, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

7

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 23, 2021

    4 yr 8 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Nov 23, 2026

    in 5 mo

  4. Exclusivity ends · ODE-388

    Orphan-drug exclusivity (7 years)

    Nov 23, 2028

    in 2 yr 6 mo

  5. Patent 12447169 expires

    Listed method-of-use patent (U-4329) expiration.

    Oct 27, 2031

    in 5 yr 5 mo

  6. Patent 11684632 expires

    Listed method-of-use patent (U-3650) expiration.

    Jan 04, 2032

    in 5 yr 8 mo

  7. Patent 12213989 expires

    Listed method-of-use patent (U-4137) expiration.

    Nov 18, 2042

    in 16 yr 8 mo

  8. Patent 12433907 expires

    Listed method-of-use patent (U-4289) expiration.

    Nov 18, 2042

    in 16 yr 8 mo

  9. Patent 12447170 expires

    Listed method-of-use patent (U-4328) expiration.

    Nov 18, 2042

    in 16 yr 8 mo

  10. Patent 12295940 expires

    Listed drug substance patent expiration.

    Oct 11, 2043

    in 17 yr 7 mo

  11. Patent 12527771 expires

    Listed drug substance patent expiration.

    Oct 11, 2043

    in 17 yr 7 mo

Pharmaceutical detail

Active ingredient

MARIBAVIR

Strength

200MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 215596

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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
12213989Nov 18, 2042in 16 yr 8 mo
U-4137
12433907Nov 18, 2042in 16 yr 8 mo
U-4289
12447170Nov 18, 2042in 16 yr 8 mo
U-4328
12295940Oct 11, 2043in 17 yr 7 mo
SubstanceProduct
12527771Oct 11, 2043in 17 yr 7 mo
SubstanceProduct
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.