Orange Book product · Brand (NDA)
JOENJA
LENIOLISIB PHOSPHATE
At a glance
Mar 24, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 24, 2023
3 yr 3 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 24, 2028
in 1 yr 9 mo
Exclusivity ends · ODE-430
Orphan-drug exclusivity (7 years)
Mar 24, 2030
in 3 yr 10 mo
Patent 8653092 expires
Listed drug substance patent expiration.
Feb 19, 2032
in 5 yr 9 mo
Pharmaceutical detail
Active ingredient
LENIOLISIB PHOSPHATE
Strength
EQ 70MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 217759
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)
Mar 24, 2028
in 1 yr 9 mo
- ODE-430Orphan-drug exclusivity (7 years)
Mar 24, 2030
in 3 yr 10 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8653092 | Feb 19, 2032 | in 5 yr 9 mo | SubstanceProduct |
