Orange Book product · Brand (NDA)
COPIKTRA
DUVELISIB
At a glance
Sep 24, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 24, 2018
7 yr 10 mo ago
Today
Patent 9216982 expires
Listed method-of-use patent (U-2413) expiration.
Jan 05, 2029
in 2 yr 7 mo
Patent 9216982 expires
Listed method-of-use patent (U-2412) expiration.
Jan 05, 2029
in 2 yr 7 mo
Patent 11312718 expires
Listed drug product patent expiration.
Jan 10, 2032
in 5 yr 8 mo
Patent 9840505 expires
Listed method-of-use patent (U-2413) expiration.
Jan 10, 2032
in 5 yr 8 mo
Patent 9840505 expires
Listed method-of-use patent (U-2412) expiration.
Jan 10, 2032
in 5 yr 8 mo
Patent RE46621 expires
Listed drug substance patent expiration.
May 17, 2032
in 6 yr
Patent 8193182 expires
Listed drug substance patent expiration.
Sep 24, 2032
in 6 yr 4 mo
Patent 12213983 expires
Listed method-of-use patent (U-2412) expiration.
Apr 26, 2035
in 9 yr
Pharmaceutical detail
Active ingredient
DUVELISIB
Strength
15MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 211155
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.
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9216982 | Jan 05, 2029 | in 2 yr 7 mo | U-2413 |
| 9216982 | Jan 05, 2029 | in 2 yr 7 mo | U-2412 |
| 11312718 | Jan 10, 2032 | in 5 yr 8 mo | Product |
| 9840505 | Jan 10, 2032 | in 5 yr 8 mo | U-2413 |
| 9840505 | Jan 10, 2032 | in 5 yr 8 mo | U-2412 |
| RE46621 | May 17, 2032 | in 6 yr | SubstanceProduct |
| 8193182 | Sep 24, 2032 | in 6 yr 4 mo | Substance |
| 12213983 | Apr 26, 2035 | in 9 yr | U-2412 |
