Orange Book product · Brand (NDA)
LEQSELVI
DEURUXOLITINIB PHOSPHATE
At a glance
Jul 25, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 25, 2024
1 yr 11 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jul 25, 2029
in 3 yr 2 mo
Patent 10561659 expires
Listed method-of-use patent (U-3976) expiration.
May 04, 2037
in 11 yr
Patent 12076323 expires
Listed method-of-use patent (U-3976) expiration.
May 04, 2037
in 11 yr
Patent 11919907 expires
Listed drug product patent expiration.
May 21, 2041
in 15 yr 2 mo
Patent 12285432 expires
Listed method-of-use patent (U-3976) expiration.
Aug 11, 2042
in 16 yr 5 mo
Patent 12247034 expires
Listed drug substance patent expiration.
May 10, 2044
in 18 yr 2 mo
Patent 12364699 expires
Listed method-of-use patent (U-3976) expiration.
Oct 10, 2044
in 18 yr 7 mo
Pharmaceutical detail
Active ingredient
DEURUXOLITINIB PHOSPHATE
Strength
EQ 8MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 217900
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 (1)
- NCENew chemical entity exclusivity (5 years)
Jul 25, 2029
in 3 yr 2 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10561659 | May 04, 2037 | in 11 yr | U-3976 |
| 12076323 | May 04, 2037 | in 11 yr | U-3976 |
| 11919907 | May 21, 2041 | in 15 yr 2 mo | ProductU-3976 |
| 12285432 | Aug 11, 2042 | in 16 yr 5 mo | U-3976 |
| 12247034 | May 10, 2044 | in 18 yr 2 mo | SubstanceProduct |
| 12364699 | Oct 10, 2044 | in 18 yr 7 mo | U-3976 |
