Orange Book product · Brand (NDA)
CALQUENCE
ACALABRUTINIB
At a glance
Oct 31, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
44
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 31, 2017
8 yr 9 mo ago
Today
Exclusivity ends · ODE-274
Orphan-drug exclusivity (7 years)
Nov 21, 2026
in 5 mo
Patent 7459554 expires
Listed drug substance patent expiration.
Nov 24, 2026
in 5 mo
Exclusivity ends · I-960
New indication exclusivity (3 years)
Jan 16, 2028
in 1 yr 7 mo
Exclusivity ends · D-200
New indication / change exclusivity (3 years)
Feb 19, 2029
in 2 yr 9 mo
Patent 10239883 expires
Listed method-of-use patent (U-2668) expiration.
Jul 11, 2032
in 6 yr 2 mo
Patent 10239883 expires
Listed method-of-use patent (U-2666) expiration.
Jul 11, 2032
in 6 yr 2 mo
Patent 9290504 expires
Listed drug substance patent expiration.
Jul 11, 2032
in 6 yr 2 mo
Patent 9758524 expires
Listed method-of-use patent (U-4108) expiration.
Jul 11, 2032
in 6 yr 2 mo
Patent 9758524 expires
Listed method-of-use patent (U-2145) expiration.
Jul 11, 2032
in 6 yr 2 mo
Patent 10272083 expires
Listed method-of-use patent (U-2519) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 10272083 expires
Listed method-of-use patent (U-2683) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 10272083 expires
Listed method-of-use patent (U-2686) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 10272083 expires
Listed method-of-use patent (U-2684) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 10272083 expires
Listed method-of-use patent (U-2687) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 10272083 expires
Listed method-of-use patent (U-2682) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 10272083 expires
Listed method-of-use patent (U-2685) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 10272083 expires
Listed method-of-use patent (U-4109) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 11771696 expires
Listed method-of-use patent (U-3710) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 11166951 expires
Listed method-of-use patent (U-4426) expiration.
Aug 11, 2035
in 9 yr 3 mo
Patent 11166951 expires
Listed method-of-use patent (U-4431) expiration.
Aug 11, 2035
in 9 yr 3 mo
Patent 11166951 expires
Listed method-of-use patent (U-4430) expiration.
Aug 11, 2035
in 9 yr 3 mo
Patent 11166951 expires
Listed method-of-use patent (U-4429) expiration.
Aug 11, 2035
in 9 yr 3 mo
Patent 11166951 expires
Listed method-of-use patent (U-4428) expiration.
Aug 11, 2035
in 9 yr 3 mo
Patent 11166951 expires
Listed method-of-use patent (U-4427) expiration.
Aug 11, 2035
in 9 yr 3 mo
Patent 10167291 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 10167291 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 10167291 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 10167291 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 10167291 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 10167291 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 10167291 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 10167291 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 10167291 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 10167291 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 10167291 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 10167291 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 10167291 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 10167291 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 10167291 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 9796721 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 9796721 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 9796721 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 9796721 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 9796721 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 9796721 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 9796721 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 9796721 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Pharmaceutical detail
Active ingredient
ACALABRUTINIB
Strength
100MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 210259
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 (3)
- ODE-274Orphan-drug exclusivity (7 years)
Nov 21, 2026
in 5 mo
- I-960New indication exclusivity (3 years)
Jan 16, 2028
in 1 yr 7 mo
- D-200New indication / change exclusivity (3 years)
Feb 19, 2029
in 2 yr 9 mo
Listed patents (44)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7459554 | Nov 24, 2026 | in 5 mo | Substance |
| 10239883 | Jul 11, 2032 | in 6 yr 2 mo | U-2668 |
| 10239883 | Jul 11, 2032 | in 6 yr 2 mo | U-2666 |
| 9290504 | Jul 11, 2032 | in 6 yr 2 mo | SubstanceProduct |
| 9758524 | Jul 11, 2032 | in 6 yr 2 mo | U-4108 |
| 9758524 | Jul 11, 2032 | in 6 yr 2 mo | U-2145 |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-2519 |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-2683 |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-2686 |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-2684 |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-2687 |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-2682 |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-2685 |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-4109 |
| 11771696 | Jan 21, 2035 | in 8 yr 9 mo | U-3710 |
| 11166951 | Aug 11, 2035 | in 9 yr 3 mo | U-4426 |
| 11166951 | Aug 11, 2035 | in 9 yr 3 mo | U-4431 |
| 11166951 | Aug 11, 2035 | in 9 yr 3 mo | U-4430 |
| 11166951 | Aug 11, 2035 | in 9 yr 3 mo | U-4429 |
| 11166951 | Aug 11, 2035 | in 9 yr 3 mo | U-4428 |
| 11166951 | Aug 11, 2035 | in 9 yr 3 mo | U-4427 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-2667 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-2670 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-2666 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-2668 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-2669 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-2671 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-4109 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-2519 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-2684 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-2685 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-2682 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-2683 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-2687 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-2686 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-2145 |
| 9796721 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-2145 |
| 9796721 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-2669 |
| 9796721 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-2671 |
| 9796721 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-2670 |
| 9796721 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-2668 |
| 9796721 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-2666 |
| 9796721 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-2667 |
| 9796721 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-4108 |

