Orange Book product · Brand (NDA)
OJJAARA
MOMELOTINIB DIHYDROCHLORIDE
At a glance
Sep 15, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 15, 2023
2 yr 10 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 15, 2028
in 2 yr 3 mo
Exclusivity ends · ODE-441
Orphan-drug exclusivity (7 years)
Sep 15, 2030
in 4 yr 4 mo
Patent 8486941 expires
Listed drug substance patent expiration.
Jan 03, 2035
in 8 yr 8 mo
Patent 9809559 expires
Listed method-of-use patent (U-1201) expiration.
Jun 11, 2035
in 9 yr 1 mo
Patent RE48285 expires
Listed drug substance patent expiration.
Jun 11, 2035
in 9 yr 1 mo
Patent 12576089 expires
Listed method-of-use patent (U-4441) expiration.
Aug 21, 2039
in 13 yr 4 mo
Patent 11963962 expires
Listed method-of-use patent (U-3928) expiration.
Dec 02, 2040
in 14 yr 8 mo
Pharmaceutical detail
Active ingredient
MOMELOTINIB DIHYDROCHLORIDE
Strength
EQ 100MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 216873
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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)
Sep 15, 2028
in 2 yr 3 mo
- ODE-441Orphan-drug exclusivity (7 years)
Sep 15, 2030
in 4 yr 4 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8486941 | Jan 03, 2035 | in 8 yr 8 mo | SubstanceProductU-1201 |
| 9809559 | Jun 11, 2035 | in 9 yr 1 mo | U-1201 |
| RE48285 | Jun 11, 2035 | in 9 yr 1 mo | SubstanceProductU-1201 |
| 12576089 | Aug 21, 2039 | in 13 yr 4 mo | U-4441 |
| 11963962 | Dec 02, 2040 | in 14 yr 8 mo | U-3928 |
