Assyro AI

Orange Book product · Brand (NDA)

REZUROCK

BELUMOSUDIL MESYLATE

Brand (NDA)NDA 214783RX KADMON PHARMS LLC

At a glance

Jul 16, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

7

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 16, 2021

    5 yr ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Jul 16, 2026

    in 27 d

  4. Exclusivity ends · ODE-362

    Orphan-drug exclusivity (7 years)

    Jul 16, 2028

    in 2 yr 1 mo

  5. Patent 10183931 expires

    Listed method-of-use patent (U-4260) expiration.

    Oct 07, 2033

    in 7 yr 5 mo

  6. Patent 10183931 expires

    Listed method-of-use patent (U-3246) expiration.

    Oct 07, 2033

    in 7 yr 5 mo

  7. Patent 10696660 expires

    Listed method-of-use patent (U-4260) expiration.

    Oct 07, 2033

    in 7 yr 5 mo

  8. Patent 10696660 expires

    Listed method-of-use patent (U-3246) expiration.

    Oct 07, 2033

    in 7 yr 5 mo

  9. Patent 8357693 expires

    Listed drug substance patent expiration.

    Jun 20, 2034

    in 8 yr 1 mo

  10. Patent 11311541 expires

    Listed method-of-use patent (U-3369) expiration.

    Apr 09, 2035

    in 8 yr 11 mo

  11. Patent 12097202 expires

    Listed method-of-use patent (U-4014) expiration.

    Jul 14, 2042

    in 16 yr 4 mo

Pharmaceutical detail

Active ingredient

BELUMOSUDIL MESYLATE

Strength

EQ 200MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 214783

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)

    Jul 16, 2026

    in 27 d

  • ODE-362Orphan-drug exclusivity (7 years)

    Jul 16, 2028

    in 2 yr 1 mo

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10183931Oct 07, 2033in 7 yr 5 mo
U-4260
10183931Oct 07, 2033in 7 yr 5 mo
U-3246
10696660Oct 07, 2033in 7 yr 5 mo
U-4260
10696660Oct 07, 2033in 7 yr 5 mo
U-3246
8357693Jun 20, 2034in 8 yr 1 mo
SubstanceProductU-4259
11311541Apr 09, 2035in 8 yr 11 mo
U-3369
12097202Jul 14, 2042in 16 yr 4 mo
U-4014
Agent CTA Background

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