acalabrutinib · Astrazeneca · NDA 210259, 216387
Calquence
Earliest generic entry, as listed · earliest of 2 marketed strengths
1 Jul 2036
Blocked by patent: US 10167291, US 11059829, US 9796721.
Listed patents · 10 unexpired
52 Orange Book listing rows for 10 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10167291 | drug product, use U-2145, U-2519, U-2666, U-2667, U-2668, U-2669, U-2670, U-2671, U-2682, U-2683, U-2684, U-2685, U-2686, U-2687, U-4109 | 1 Jul 2036 |
| US 10167291 listing row | drug product, use U-2145 · sets the listed date | 1 Jul 2036 |
| US 10167291 listing row | drug product, use U-2519 · sets the listed date | 1 Jul 2036 |
| US 10167291 listing row | drug product, use U-2666 · sets the listed date | 1 Jul 2036 |
| US 10167291 listing row | drug product, use U-2667 · sets the listed date | 1 Jul 2036 |
| US 10167291 listing row | drug product, use U-2668 · sets the listed date | 1 Jul 2036 |
| US 10167291 listing row | drug product, use U-2669 · sets the listed date | 1 Jul 2036 |
| US 10167291 listing row | drug product, use U-2670 · sets the listed date | 1 Jul 2036 |
| US 10167291 listing row | drug product, use U-2671 · sets the listed date | 1 Jul 2036 |
| US 10167291 listing row | drug product, use U-2682 · sets the listed date | 1 Jul 2036 |
| US 10167291 listing row | drug product, use U-2683 · sets the listed date | 1 Jul 2036 |
| US 10167291 listing row | drug product, use U-2684 · sets the listed date | 1 Jul 2036 |
| US 10167291 listing row | drug product, use U-2685 · sets the listed date | 1 Jul 2036 |
| US 10167291 listing row | drug product, use U-2686 · sets the listed date | 1 Jul 2036 |
| US 10167291 listing row | drug product, use U-2687 · sets the listed date | 1 Jul 2036 |
| US 10167291 listing row | drug product, use U-4109 · sets the listed date | 1 Jul 2036 |
| US 11059829 | drug substance, drug product, use U-2145, U-2666, U-2667, U-2668, U-2669, U-2670, U-2671, U-4108 | 1 Jul 2036 |
| US 11059829 listing row | drug substance, drug product, use U-2145 · sets the listed date | 1 Jul 2036 |
| US 11059829 listing row | drug substance, drug product, use U-2666 · sets the listed date | 1 Jul 2036 |
| US 11059829 listing row | drug substance, drug product, use U-2667 · sets the listed date | 1 Jul 2036 |
| US 11059829 listing row | drug substance, drug product, use U-2668 · sets the listed date | 1 Jul 2036 |
| US 11059829 listing row | drug substance, drug product, use U-2669 · sets the listed date | 1 Jul 2036 |
| US 11059829 listing row | drug substance, drug product, use U-2670 · sets the listed date | 1 Jul 2036 |
| US 11059829 listing row | drug substance, drug product, use U-2671 · sets the listed date | 1 Jul 2036 |
| US 11059829 listing row | drug substance, drug product, use U-4108 · sets the listed date | 1 Jul 2036 |
| US 9796721 | drug substance, drug product, use U-2145, U-2666, U-2667, U-2668, U-2669, U-2670, U-2671, U-4108 | 1 Jul 2036 |
| US 9796721 listing row | drug substance, drug product, use U-2145 · sets the listed date | 1 Jul 2036 |
| US 9796721 listing row | drug substance, drug product, use U-2666 · sets the listed date | 1 Jul 2036 |
| US 9796721 listing row | drug substance, drug product, use U-2667 · sets the listed date | 1 Jul 2036 |
| US 9796721 listing row | drug substance, drug product, use U-2668 · sets the listed date | 1 Jul 2036 |
| US 9796721 listing row | drug substance, drug product, use U-2669 · sets the listed date | 1 Jul 2036 |
| US 9796721 listing row | drug substance, drug product, use U-2670 · sets the listed date | 1 Jul 2036 |
| US 9796721 listing row | drug substance, drug product, use U-2671 · sets the listed date | 1 Jul 2036 |
| US 9796721 listing row | drug substance, drug product, use U-4108 · sets the listed date | 1 Jul 2036 |
| US 11166951 | use U-4426, U-4427, U-4428, U-4429, U-4430, U-4431 | 11 Aug 2035 |
| US 11166951 listing row | use U-4426 | 11 Aug 2035 |
| US 11166951 listing row | use U-4427 | 11 Aug 2035 |
| US 11166951 listing row | use U-4428 | 11 Aug 2035 |
| US 11166951 listing row | use U-4429 | 11 Aug 2035 |
| US 11166951 listing row | use U-4430 | 11 Aug 2035 |
| US 11166951 listing row | use U-4431 | 11 Aug 2035 |
| US 10272083 | use U-2519, U-2682, U-2683, U-2684, U-2685, U-2686, U-2687, U-4109 | 21 Jan 2035 |
| US 10272083 listing row | use U-2519 | 21 Jan 2035 |
| US 10272083 listing row | use U-2682 | 21 Jan 2035 |
| US 10272083 listing row | use U-2683 | 21 Jan 2035 |
| US 10272083 listing row | use U-2684 | 21 Jan 2035 |
| US 10272083 listing row | use U-2685 | 21 Jan 2035 |
| US 10272083 listing row | use U-2686 | 21 Jan 2035 |
| US 10272083 listing row | use U-2687 | 21 Jan 2035 |
| US 10272083 listing row | use U-4109 | 21 Jan 2035 |
| US 11771696 | use U-3710 | 21 Jan 2035 |
| US 10239883 | use U-2666, U-2668 | 11 Jul 2032 |
| US 10239883 listing row | use U-2666 | 11 Jul 2032 |
| US 10239883 listing row | use U-2668 | 11 Jul 2032 |
| US 9290504 | drug substance, drug product | 11 Jul 2032 |
| US 9758524 | use U-2145, U-4108 | 11 Jul 2032 |
| US 9758524 listing row | use U-2145 | 11 Jul 2032 |
| US 9758524 listing row | use U-4108 | 11 Jul 2032 |
| US 7459554 | drug substance | 24 Nov 2026 |
Exclusivities · 3 unexpired
| D-200 | new dosing schedule | 19 Feb 2029 |
| I-960 | new indication (3 years) | 16 Jan 2028 |
| ODE-274 | orphan drug (7 years) | 21 Nov 2026 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 24 Oct 2026Exclusivity expires within 90 days ODE-274 · 210259-00121 Nov 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210259 · 001 · RLD | capsule, oral | 100MG | 1 Jul 2036 |
| 216387 · 001 · RLD | tablet, oral | EQ 100MG BASE | 1 Jul 2036 |