FDA Orange Book · active-ingredient family
Acalabrutinib
Acalabrutinib is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:CALQUENCE · NDA 210259
1
Brand (NDA)
0
Generics (ANDA)
9
Listed patents
3
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CALQUENCERLD | ASTRAZENECA | NDA 210259 | — | Oct 31, 2017 |
Marketing exclusivity (3)
- D-200New indication / change exclusivity (3 years)
Feb 19, 2029
in 2 yr 9 mo
- I-960New indication exclusivity (3 years)
Jan 16, 2028
in 1 yr 7 mo
- ODE-274Orphan-drug exclusivity (7 years)
Nov 21, 2026
in 5 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7459554 | Nov 24, 2026 | in 5 mo | Substance |
| 10239883 | Jul 11, 2032 | in 6 yr 2 mo | U-2668 |
| 9758524 | Jul 11, 2032 | in 6 yr 2 mo | U-4108 |
| 9290504 | Jul 11, 2032 | in 6 yr 2 mo | SubstanceProduct |
| 10272083 | Jan 21, 2035 | in 8 yr 9 mo | U-2519 |
| 11771696 | Jan 21, 2035 | in 8 yr 9 mo | U-3710 |
| 11166951 | Aug 11, 2035 | in 9 yr 3 mo | U-4426 |
| 9796721 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-2145 |
| 10167291 | Jul 01, 2036 | in 10 yr 2 mo | ProductU-2667 |
Acalabrutinib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
