Orange Book product · Brand (NDA)
REZUROCK
BELUMOSUDIL MESYLATE
At a glance
Jul 16, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 16, 2021
5 yr ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jul 16, 2026
in 27 d
Exclusivity ends · ODE-362
Orphan-drug exclusivity (7 years)
Jul 16, 2028
in 2 yr 1 mo
Patent 10183931 expires
Listed method-of-use patent (U-4260) expiration.
Oct 07, 2033
in 7 yr 5 mo
Patent 10183931 expires
Listed method-of-use patent (U-3246) expiration.
Oct 07, 2033
in 7 yr 5 mo
Patent 10696660 expires
Listed method-of-use patent (U-4260) expiration.
Oct 07, 2033
in 7 yr 5 mo
Patent 10696660 expires
Listed method-of-use patent (U-3246) expiration.
Oct 07, 2033
in 7 yr 5 mo
Patent 8357693 expires
Listed drug substance patent expiration.
Jun 20, 2034
in 8 yr 1 mo
Patent 11311541 expires
Listed method-of-use patent (U-3369) expiration.
Apr 09, 2035
in 8 yr 11 mo
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 familyThis 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)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10183931 | Oct 07, 2033 | in 7 yr 5 mo | U-4260 |
| 10183931 | Oct 07, 2033 | in 7 yr 5 mo | U-3246 |
| 10696660 | Oct 07, 2033 | in 7 yr 5 mo | U-4260 |
| 10696660 | Oct 07, 2033 | in 7 yr 5 mo | U-3246 |
| 8357693 | Jun 20, 2034 | in 8 yr 1 mo | SubstanceProductU-4259 |
| 11311541 | Apr 09, 2035 | in 8 yr 11 mo | U-3369 |
| 12097202 | Jul 14, 2042 | in 16 yr 4 mo | U-4014 |

