Orange Book product · Brand (NDA)
CALQUENCE
ACALABRUTINIB MALEATE
At a glance
Aug 03, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
29
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 03, 2022
3 yr 11 mo ago
Today
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-2666) expiration.
Jul 11, 2032
in 6 yr 2 mo
Patent 10239883 expires
Listed method-of-use patent (U-2668) 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-4109) expiration.
Jan 21, 2035
in 8 yr 9 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-2682) 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-2684) 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-2686) 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 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-4427) 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-4429) 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-4431) expiration.
Aug 11, 2035
in 9 yr 3 mo
Patent 11059829 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 11059829 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 11059829 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 11059829 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 11059829 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 11059829 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 11059829 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 11059829 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Pharmaceutical detail
Active ingredient
ACALABRUTINIB MALEATE
Strength
EQ 100MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 216387
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)
- 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 (29)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7459554 | Nov 24, 2026 | in 5 mo | Substance |
| 10239883 | Jul 11, 2032 | in 6 yr 2 mo | U-2666 |
| 10239883 | Jul 11, 2032 | in 6 yr 2 mo | U-2668 |
| 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-4109 |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-2519 |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-2682 |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-2683 |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-2684 |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-2685 |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-2686 |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-2687 |
| 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-4427 |
| 11166951 | Aug 11, 2035 | in 9 yr 3 mo | U-4428 |
| 11166951 | Aug 11, 2035 | in 9 yr 3 mo | U-4429 |
| 11166951 | Aug 11, 2035 | in 9 yr 3 mo | U-4430 |
| 11166951 | Aug 11, 2035 | in 9 yr 3 mo | U-4431 |
| 11059829 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-4108 |
| 11059829 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-2145 |
| 11059829 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-2671 |
| 11059829 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-2670 |
| 11059829 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-2669 |
| 11059829 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-2668 |
| 11059829 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-2667 |
| 11059829 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-2666 |

