Orange Book product · Brand (NDA)
REZLIDHIA
OLUTASIDENIB
At a glance
Dec 01, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 01, 2022
3 yr 7 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Dec 01, 2027
in 1 yr 6 mo
Exclusivity ends · ODE-413
Orphan-drug exclusivity (7 years)
Dec 01, 2029
in 3 yr 6 mo
Patent 10414752 expires
Listed drug product patent expiration.
Sep 18, 2035
in 9 yr 5 mo
Patent 10550098 expires
Listed drug product patent expiration.
Sep 18, 2035
in 9 yr 5 mo
Patent 11498913 expires
Listed drug product patent expiration.
Sep 18, 2035
in 9 yr 5 mo
Patent 12275715 expires
Listed drug substance patent expiration.
Sep 18, 2035
in 9 yr 5 mo
Patent 9834539 expires
Listed drug substance patent expiration.
Sep 18, 2035
in 9 yr 5 mo
Patent 10532047 expires
Listed drug substance patent expiration.
May 16, 2039
in 13 yr 1 mo
Patent 10959994 expires
Listed drug product patent expiration.
May 16, 2039
in 13 yr 1 mo
Patent 11013733 expires
Listed method-of-use patent (U-3496) expiration.
May 16, 2039
in 13 yr 1 mo
Patent 11013734 expires
Listed method-of-use patent (U-3495) expiration.
May 16, 2039
in 13 yr 1 mo
Patent 11376246 expires
Listed method-of-use patent (U-3495) expiration.
May 16, 2039
in 13 yr 1 mo
Patent 11497743 expires
Listed method-of-use patent (U-3495) expiration.
May 16, 2039
in 13 yr 1 mo
Patent 12053463 expires
Listed drug substance patent expiration.
May 16, 2039
in 13 yr 1 mo
Patent 11738018 expires
Listed method-of-use patent (U-3684) expiration.
Jul 17, 2039
in 13 yr 3 mo
Patent 11723905 expires
Listed drug product patent expiration.
Nov 12, 2039
in 13 yr 7 mo
Pharmaceutical detail
Active ingredient
OLUTASIDENIB
Strength
150MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 215814
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)
Dec 01, 2027
in 1 yr 6 mo
- ODE-413Orphan-drug exclusivity (7 years)
Dec 01, 2029
in 3 yr 6 mo
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10414752 | Sep 18, 2035 | in 9 yr 5 mo | Product |
| 10550098 | Sep 18, 2035 | in 9 yr 5 mo | Product |
| 11498913 | Sep 18, 2035 | in 9 yr 5 mo | Product |
| 12275715 | Sep 18, 2035 | in 9 yr 5 mo | SubstanceProductU-3684 |
| 9834539 | Sep 18, 2035 | in 9 yr 5 mo | SubstanceProductU-3497 |
| 10532047 | May 16, 2039 | in 13 yr 1 mo | Substance |
| 10959994 | May 16, 2039 | in 13 yr 1 mo | Product |
| 11013733 | May 16, 2039 | in 13 yr 1 mo | U-3496 |
| 11013734 | May 16, 2039 | in 13 yr 1 mo | U-3495 |
| 11376246 | May 16, 2039 | in 13 yr 1 mo | U-3495 |
| 11497743 | May 16, 2039 | in 13 yr 1 mo | U-3495 |
| 12053463 | May 16, 2039 | in 13 yr 1 mo | SubstanceProduct |
| 11738018 | Jul 17, 2039 | in 13 yr 3 mo | U-3684 |
| 11723905 | Nov 12, 2039 | in 13 yr 7 mo | Product |
