FDA Orange Book
Is there a generic for Calquence?
Calquence contains acalabrutinib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Calquence (acalabrutinib). The Orange Book shows its last listed patent expires July 1, 2036 and its last listed exclusivity ends February 19, 2029.
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Calquence products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
NDA 210259, 216387, held by ASTRAZENECA UK LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Calquence patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7459554 | November 24, 2026 | Drug substance | None | 210259 |
| 10239883 | July 11, 2032 | Method of use | U-2668 | 210259 |
| 10239883 | July 11, 2032 | Method of use | U-2666 | 210259 |
| 9758524 | July 11, 2032 | Method of use | U-4108 | 210259 |
| 9758524 | July 11, 2032 | Method of use | U-2145 | 210259 |
| 9290504 | July 11, 2032 | Drug substance, Drug product | None | 210259 |
| 10272083 | January 21, 2035 | Method of use | U-2519 | 210259 |
| 10272083 | January 21, 2035 | Method of use | U-2683 | 210259 |
| 10272083 | January 21, 2035 | Method of use | U-2686 | 210259 |
| 10272083 | January 21, 2035 | Method of use | U-2684 | 210259 |
| 10272083 | January 21, 2035 | Method of use | U-2687 | 210259 |
| 10272083 | January 21, 2035 | Method of use | U-2682 | 210259 |
| 10272083 | January 21, 2035 | Method of use | U-2685 | 210259 |
| 10272083 | January 21, 2035 | Method of use | U-4109 | 210259 |
| 11771696 | January 21, 2035 | Method of use | U-3710 | 210259 |
| 11166951 | August 11, 2035 | Method of use | U-4426 | 210259 |
| 11166951 | August 11, 2035 | Method of use | U-4431 | 210259 |
| 11166951 | August 11, 2035 | Method of use | U-4430 | 210259 |
| 11166951 | August 11, 2035 | Method of use | U-4429 | 210259 |
| 11166951 | August 11, 2035 | Method of use | U-4428 | 210259 |
| 11166951 | August 11, 2035 | Method of use | U-4427 | 210259 |
| 9796721 | July 1, 2036 | Drug substance, Drug product | U-2145 | 210259 |
| 10167291 | July 1, 2036 | Drug product | U-2667 | 210259 |
| 10167291 | July 1, 2036 | Drug product | U-2670 | 210259 |
| 10167291 | July 1, 2036 | Drug product | U-2666 | 210259 |
| 10167291 | July 1, 2036 | Drug product | U-2668 | 210259 |
| 10167291 | July 1, 2036 | Drug product | U-2669 | 210259 |
| 10167291 | July 1, 2036 | Drug product | U-2671 | 210259 |
| 9796721 | July 1, 2036 | Drug substance, Drug product | U-2669 | 210259 |
| 9796721 | July 1, 2036 | Drug substance, Drug product | U-2671 | 210259 |
| 9796721 | July 1, 2036 | Drug substance, Drug product | U-2670 | 210259 |
| 9796721 | July 1, 2036 | Drug substance, Drug product | U-2668 | 210259 |
| 9796721 | July 1, 2036 | Drug substance, Drug product | U-2666 | 210259 |
| 9796721 | July 1, 2036 | Drug substance, Drug product | U-2667 | 210259 |
| 9796721 | July 1, 2036 | Drug substance, Drug product | U-4108 | 210259 |
| 10167291 | July 1, 2036 | Drug product | U-4109 | 210259 |
| 10167291 | July 1, 2036 | Drug product | U-2519 | 210259 |
| 10167291 | July 1, 2036 | Drug product | U-2684 | 210259 |
| 10167291 | July 1, 2036 | Drug product | U-2685 | 210259 |
| 10167291 | July 1, 2036 | Drug product | U-2682 | 210259 |
| 10167291 | July 1, 2036 | Drug product | U-2683 | 210259 |
| 10167291 | July 1, 2036 | Drug product | U-2687 | 210259 |
| 10167291 | July 1, 2036 | Drug product | U-2686 | 210259 |
| 10167291 | July 1, 2036 | Drug product | U-2145 | 210259 |
| 11059829 | July 1, 2036 | Drug substance, Drug product | U-4108 | 216387 |
| 11059829 | July 1, 2036 | Drug substance, Drug product | U-2145 | 216387 |
| 11059829 | July 1, 2036 | Drug substance, Drug product | U-2671 | 216387 |
| 11059829 | July 1, 2036 | Drug substance, Drug product | U-2670 | 216387 |
| 11059829 | July 1, 2036 | Drug substance, Drug product | U-2669 | 216387 |
| 11059829 | July 1, 2036 | Drug substance, Drug product | U-2668 | 216387 |
| 11059829 | July 1, 2036 | Drug substance, Drug product | U-2667 | 216387 |
| 11059829 | July 1, 2036 | Drug substance, Drug product | U-2666 | 216387 |
Calquence exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-274 | Orphan drug exclusivity | November 21, 2026 | 210259 |
| I-960 | New indication | January 16, 2028 | 210259 |
| D-200 | New dosing schedule | February 19, 2029 | 210259 |
Calquence NDC codes
Questions
Is there a generic for Calquence?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Calquence (acalabrutinib). The Orange Book shows its last listed patent expires July 1, 2036 and its last listed exclusivity ends February 19, 2029.
What is the generic name for Calquence?
The active ingredient in Calquence is acalabrutinib, per the FDA Orange Book.
When does the Calquence patent expire?
The last patent listed for Calquence in the Orange Book expires July 1, 2036. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.