Assyro AI

Orange Book product · Brand (NDA)

REVUFORJ

REVUMENIB CITRATE

Brand (NDA)NDA 218944RX SYNDAX

At a glance

Nov 15, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

5

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 15, 2024

    1 yr 7 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Nov 15, 2029

    in 3 yr 6 mo

  4. Exclusivity ends · ODE-502

    Orphan-drug exclusivity (7 years)

    Nov 15, 2031

    in 5 yr 6 mo

  5. Exclusivity ends · ODE-504

    Orphan-drug exclusivity (7 years)

    Nov 15, 2031

    in 5 yr 6 mo

  6. Exclusivity ends · ODE-505

    Orphan-drug exclusivity (7 years)

    Nov 15, 2031

    in 5 yr 6 mo

  7. Patent 10683302 expires

    Listed drug substance patent expiration.

    Jun 08, 2037

    in 11 yr 2 mo

  8. Patent 11479557 expires

    Listed drug product patent expiration.

    Jun 08, 2037

    in 11 yr 2 mo

  9. Patent 11479557 expires

    Listed drug product patent expiration.

    Jun 08, 2037

    in 11 yr 2 mo

  10. Patent 12564590 expires

    Listed drug product patent expiration.

    Dec 18, 2042

    in 16 yr 9 mo

  11. Patent 12564590 expires

    Listed drug product patent expiration.

    Dec 18, 2042

    in 16 yr 9 mo

Pharmaceutical detail

Active ingredient

REVUMENIB CITRATE

Strength

EQ 25MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 218944

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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 (4)

  • NCENew chemical entity exclusivity (5 years)

    Nov 15, 2029

    in 3 yr 6 mo

  • ODE-502Orphan-drug exclusivity (7 years)

    Nov 15, 2031

    in 5 yr 6 mo

  • ODE-504Orphan-drug exclusivity (7 years)

    Nov 15, 2031

    in 5 yr 6 mo

  • ODE-505Orphan-drug exclusivity (7 years)

    Nov 15, 2031

    in 5 yr 6 mo

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10683302Jun 08, 2037in 11 yr 2 mo
SubstanceProduct
11479557Jun 08, 2037in 11 yr 2 mo
ProductU-4327
11479557Jun 08, 2037in 11 yr 2 mo
ProductU-4045
12564590Dec 18, 2042in 16 yr 9 mo
ProductU-4045
12564590Dec 18, 2042in 16 yr 9 mo
ProductU-4327
Agent CTA Background

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