Orange Book product · Brand (NDA)
UKONIQ
UMBRALISIB TOSYLATE
At a glance
Feb 05, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
15
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 05, 2021
5 yr 5 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Feb 05, 2026
4 mo ago
Today
Patent 10072013 expires
Listed method-of-use patent (U-3063) expiration.
Jul 02, 2033
in 7 yr 2 mo
Patent 10072013 expires
Listed method-of-use patent (U-3064) expiration.
Jul 02, 2033
in 7 yr 2 mo
Patent 10570142 expires
Listed drug substance patent expiration.
Jul 02, 2033
in 7 yr 2 mo
Patent 10570142 expires
Listed drug substance patent expiration.
Jul 02, 2033
in 7 yr 2 mo
Patent 10981919 expires
Listed method-of-use patent (U-3063) expiration.
Jul 02, 2033
in 7 yr 2 mo
Patent 10981919 expires
Listed method-of-use patent (U-3064) expiration.
Jul 02, 2033
in 7 yr 2 mo
Patent 9150579 expires
Listed drug substance patent expiration.
Jul 02, 2033
in 7 yr 2 mo
Patent 9669033 expires
Listed method-of-use patent (U-3063) expiration.
Jul 02, 2033
in 7 yr 2 mo
Patent 9669033 expires
Listed method-of-use patent (U-3064) expiration.
Jul 02, 2033
in 7 yr 2 mo
Patent 10414773 expires
Listed drug substance patent expiration.
May 26, 2035
in 9 yr 1 mo
Patent 10414773 expires
Listed drug substance patent expiration.
May 26, 2035
in 9 yr 1 mo
Patent 10947244 expires
Listed method-of-use patent (U-3063) expiration.
May 26, 2035
in 9 yr 1 mo
Patent 10947244 expires
Listed method-of-use patent (U-3064) expiration.
May 26, 2035
in 9 yr 1 mo
Patent 9969740 expires
Listed drug substance patent expiration.
May 26, 2035
in 9 yr 1 mo
Patent 9969740 expires
Listed drug substance patent expiration.
May 26, 2035
in 9 yr 1 mo
Pharmaceutical detail
Active ingredient
UMBRALISIB TOSYLATE
Strength
EQ 200MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 213176
Product number
001
Marketing status
DISCN
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 (1)
- NCENew chemical entity exclusivity (5 years)
Feb 05, 2026
4 mo ago
Listed patents (15)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10072013 | Jul 02, 2033 | in 7 yr 2 mo | U-3063 |
| 10072013 | Jul 02, 2033 | in 7 yr 2 mo | U-3064 |
| 10570142 | Jul 02, 2033 | in 7 yr 2 mo | SubstanceProductU-3064 |
| 10570142 | Jul 02, 2033 | in 7 yr 2 mo | SubstanceProductU-3063 |
| 10981919 | Jul 02, 2033 | in 7 yr 2 mo | U-3063 |
| 10981919 | Jul 02, 2033 | in 7 yr 2 mo | U-3064 |
| 9150579 | Jul 02, 2033 | in 7 yr 2 mo | SubstanceProduct |
| 9669033 | Jul 02, 2033 | in 7 yr 2 mo | U-3063 |
| 9669033 | Jul 02, 2033 | in 7 yr 2 mo | U-3064 |
| 10414773 | May 26, 2035 | in 9 yr 1 mo | SubstanceProductU-3063 |
| 10414773 | May 26, 2035 | in 9 yr 1 mo | SubstanceProductU-3064 |
| 10947244 | May 26, 2035 | in 9 yr 1 mo | U-3063 |
| 10947244 | May 26, 2035 | in 9 yr 1 mo | U-3064 |
| 9969740 | May 26, 2035 | in 9 yr 1 mo | SubstanceProductU-3064 |
| 9969740 | May 26, 2035 | in 9 yr 1 mo | SubstanceProductU-3063 |
