Product profile · United States
CALQUENCE
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US10272083 claims 1 and 8 jointly cover CLL/SLL and MCL standard 100mg BID use; crystal-form tail remains through 2036-07-01.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7459554 | 2026-11-24 | DS — | Y | Y | TRUE_DS | — | — | — |
| 7459554 | 2026-11-24 | DS — | Y | Y | TRUE_DS Claim 1 Formula I imidazo[1,5-a]pyrazin-8-amine genus visually verified, with Q1 substituted aryl permitting the benzamide/pyridyl group and R1 substituted heterocyclyl permitting N-butynoyl pyrrolidine of acalabrutinib. No crystal, formulation or indication limitation. PTA correction from 365 to 771 days retained; current Orange Book expiry used. | — | — | — |
| 10239883 | 2032-07-11 | U U-2668 | N | N | LIMITED_USE | — | — | — |
| 10239883 | 2032-07-11 | U U-2666 | N | N | LIMITED_USE | — | — | — |
| 10239883 | 2032-07-11 | U U-2668 | N | N | LIMITED_USE Acalabrutinib treatment of CLL; does not cover all approved MCL indications. | — | — | — |
| 10239883 | 2032-07-11 | U U-2666 | N | N | LIMITED_USE Acalabrutinib treatment of CLL; does not cover all approved MCL indications. | — | — | — |
| 9290504 | 2032-07-11 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 9290504 | 2032-07-11 | DS/DP — | Y | Y | TRUE_DS Independent claim 30 explicitly names acalabrutinib, without crystal, formulation or indication restriction; other species in the same patent do not narrow that claim. | — | — | — |
| 9758524 | 2032-07-11 | U U-2145 | N | N | LIMITED_USE | — | — | — |
| 9758524 | 2032-07-11 | U U-4108 | N | N | LIMITED_USE | — | — | — |
| 9758524 | 2032-07-11 | U U-2145 | N | N | LIMITED_USE Acalabrutinib method broadly covers MCL but excludes CLL/SLL; complementary coverage evaluated with CLL/SLL patents. | — | — | — |
| 9758524 | 2032-07-11 | U U-4108 | N | N | LIMITED_USE Acalabrutinib method broadly covers MCL but excludes CLL/SLL; complementary coverage evaluated with CLL/SLL patents. | — | — | — |
| 10272083 | 2035-01-21 | U U-2687 | N | N | LIMITED_USE | — | — | — |
| 10272083 | 2035-01-21 | U U-2519 | N | N | LIMITED_USE | — | — | — |
| 10272083 | 2035-01-21 | U U-4109 | N | N | LIMITED_USE | — | — | — |
| 10272083 | 2035-01-21 | U U-2685 | N | N | LIMITED_USE | — | — | — |
| 10272083 | 2035-01-21 | U U-2686 | N | N | LIMITED_USE | — | — | — |
| 10272083 | 2035-01-21 | U U-2684 | N | N | LIMITED_USE | — | — | — |
| 10272083 | 2035-01-21 | U U-2683 | N | N | LIMITED_USE | — | — | — |
| 10272083 | 2035-01-21 | U U-2682 | N | N | LIMITED_USE | — | — | — |
| 10272083 | 2035-01-21 | U U-2684 | N | N | LIMITED_USE Acalabrutinib 100 mg twice daily for CLL/SLL; does not cover MCL. | — | — | — |
| 10272083 | 2035-01-21 | U U-2683 | N | N | LIMITED_USE Acalabrutinib 100 mg twice daily for CLL/SLL; does not cover MCL. | — | — | — |
| 10272083 | 2035-01-21 | U U-2682 | N | N | LIMITED_USE Acalabrutinib 100 mg twice daily for CLL/SLL; does not cover MCL. | — | — | — |
| 10272083 | 2035-01-21 | U U-2686 | N | N | LIMITED_USE Acalabrutinib 100 mg twice daily for CLL/SLL; does not cover MCL. | — | — | — |
| 10272083 | 2035-01-21 | U U-2685 | N | N | LIMITED_USE Acalabrutinib 100 mg twice daily for CLL/SLL; does not cover MCL. | — | — | — |
| 10272083 | 2035-01-21 | U U-4109 | N | N | LIMITED_USE Acalabrutinib 100 mg twice daily for CLL/SLL; does not cover MCL. | — | — | — |
| 10272083 | 2035-01-21 | U U-2519 | N | N | LIMITED_USE Acalabrutinib 100 mg twice daily for CLL/SLL; does not cover MCL. | — | — | — |
| 10272083 | 2035-01-21 | U U-2687 | N | N | LIMITED_USE Acalabrutinib 100 mg twice daily for CLL/SLL; does not cover MCL. | — | — | — |
| 11771696 | 2035-01-21 | U U-3710 | N | N | LIMITED_USE | — | — | — |
| 11771696 | 2035-01-21 | U U-3710 | N | N | LIMITED_USE Acalabrutinib CLL regimen; does not cover all MCL and CLL/SLL alternatives. | — | — | — |
| 11166951 | 2035-08-11 | U U-4427 | N | N | LIMITED_COMBINATION_USE | — | — | — |
| 11166951 | 2035-08-11 | U U-4428 | N | N | LIMITED_COMBINATION_USE | — | — | — |
| 11166951 | 2035-08-11 | U U-4430 | N | N | LIMITED_COMBINATION_USE | — | — | — |
| 11166951 | 2035-08-11 | U U-4429 | N | N | LIMITED_COMBINATION_USE | — | — | — |
| 11166951 | 2035-08-11 | U U-4431 | N | N | LIMITED_COMBINATION_USE | — | — | — |
| 11166951 | 2035-08-11 | U U-4426 | N | N | LIMITED_COMBINATION_USE | — | — | — |
| 11166951 | 2035-08-11 | U U-4428 | N | N | LIMITED_COMBINATION_USE Acalabrutinib plus a specified BCL-2 inhibitor for CLL/SLL; excludes MCL and other approved regimens. | — | — | — |
| 11166951 | 2035-08-11 | U U-4427 | N | N | LIMITED_COMBINATION_USE Acalabrutinib plus a specified BCL-2 inhibitor for CLL/SLL; excludes MCL and other approved regimens. | — | — | — |
| 11166951 | 2035-08-11 | U U-4429 | N | N | LIMITED_COMBINATION_USE Acalabrutinib plus a specified BCL-2 inhibitor for CLL/SLL; excludes MCL and other approved regimens. | — | — | — |
| 11166951 | 2035-08-11 | U U-4426 | N | N | LIMITED_COMBINATION_USE Acalabrutinib plus a specified BCL-2 inhibitor for CLL/SLL; excludes MCL and other approved regimens. | — | — | — |
| 11166951 | 2035-08-11 | U U-4431 | N | N | LIMITED_COMBINATION_USE Acalabrutinib plus a specified BCL-2 inhibitor for CLL/SLL; excludes MCL and other approved regimens. | — | — | — |
| 11166951 | 2035-08-11 | U U-4430 | N | N | LIMITED_COMBINATION_USE Acalabrutinib plus a specified BCL-2 inhibitor for CLL/SLL; excludes MCL and other approved regimens. | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2670 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2671 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2667 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2145 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2682 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2519 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2666 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2687 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2669 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2685 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2686 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-4109 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2668 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2684 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2683 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2683 | N | N | CRYSTAL_FORMULATION Acalabrutinib crystalline solid composition with specific XRPD peaks and 95-105 mg loading. | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2669 | N | N | CRYSTAL_FORMULATION Acalabrutinib crystalline solid composition with specific XRPD peaks and 95-105 mg loading. | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2145 | N | N | CRYSTAL_FORMULATION Acalabrutinib crystalline solid composition with specific XRPD peaks and 95-105 mg loading. | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2685 | N | N | CRYSTAL_FORMULATION Acalabrutinib crystalline solid composition with specific XRPD peaks and 95-105 mg loading. | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2684 | N | N | CRYSTAL_FORMULATION Acalabrutinib crystalline solid composition with specific XRPD peaks and 95-105 mg loading. | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2666 | N | N | CRYSTAL_FORMULATION Acalabrutinib crystalline solid composition with specific XRPD peaks and 95-105 mg loading. | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2519 | N | N | CRYSTAL_FORMULATION Acalabrutinib crystalline solid composition with specific XRPD peaks and 95-105 mg loading. | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2682 | N | N | CRYSTAL_FORMULATION Acalabrutinib crystalline solid composition with specific XRPD peaks and 95-105 mg loading. | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2668 | N | N | CRYSTAL_FORMULATION Acalabrutinib crystalline solid composition with specific XRPD peaks and 95-105 mg loading. | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2671 | N | N | CRYSTAL_FORMULATION Acalabrutinib crystalline solid composition with specific XRPD peaks and 95-105 mg loading. | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2670 | N | N | CRYSTAL_FORMULATION Acalabrutinib crystalline solid composition with specific XRPD peaks and 95-105 mg loading. | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2667 | N | N | CRYSTAL_FORMULATION Acalabrutinib crystalline solid composition with specific XRPD peaks and 95-105 mg loading. | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-4109 | N | N | CRYSTAL_FORMULATION Acalabrutinib crystalline solid composition with specific XRPD peaks and 95-105 mg loading. | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2686 | N | N | CRYSTAL_FORMULATION Acalabrutinib crystalline solid composition with specific XRPD peaks and 95-105 mg loading. | — | — | — |
| 10167291 | 2036-07-01 | DP/U U-2687 | N | N | CRYSTAL_FORMULATION Acalabrutinib crystalline solid composition with specific XRPD peaks and 95-105 mg loading. | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-2670 | N | N | CRYSTAL_FORM | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-2668 | N | N | CRYSTAL_FORM | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-2667 | N | N | CRYSTAL_FORM | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-2669 | N | N | CRYSTAL_FORM | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-2666 | N | N | CRYSTAL_FORM | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-2145 | N | N | CRYSTAL_FORM | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-4108 | N | N | CRYSTAL_FORM | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-2671 | N | N | CRYSTAL_FORM | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-2667 | N | N | CRYSTAL_FORM Independent claim 1 requires acalabrutinib crystal form with specified XRPD peaks; not unrestricted active compound protection. | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-2666 | N | N | CRYSTAL_FORM Independent claim 1 requires acalabrutinib crystal form with specified XRPD peaks; not unrestricted active compound protection. | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-2669 | N | N | CRYSTAL_FORM Independent claim 1 requires acalabrutinib crystal form with specified XRPD peaks; not unrestricted active compound protection. | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-4108 | N | N | CRYSTAL_FORM Independent claim 1 requires acalabrutinib crystal form with specified XRPD peaks; not unrestricted active compound protection. | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-2145 | N | N | CRYSTAL_FORM Independent claim 1 requires acalabrutinib crystal form with specified XRPD peaks; not unrestricted active compound protection. | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-2671 | N | N | CRYSTAL_FORM Independent claim 1 requires acalabrutinib crystal form with specified XRPD peaks; not unrestricted active compound protection. | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-2670 | N | N | CRYSTAL_FORM Independent claim 1 requires acalabrutinib crystal form with specified XRPD peaks; not unrestricted active compound protection. | — | — | — |
| 9796721 | 2036-07-01 | DS/DP/U U-2668 | N | N | CRYSTAL_FORM Independent claim 1 requires acalabrutinib crystal form with specified XRPD peaks; not unrestricted active compound protection. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2017-10-31 | 2022-10-31 | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Y | Y | 2022-10-31 | ODE-175 + ODE-274 + I-960 + D-200
Full coverage date: 2022-10-31
| Source |
| I-817 | 2019-11-21 | 2022-11-21 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) | N | N | — | ODE-175 + ODE-274 + I-960 + D-200
Full coverage date: —
| Source |
| ODE-175 | 2017-10-31 | 2024-10-31 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY | N | N | — | ODE-175 + ODE-274 + I-960 + D-200
Full coverage date: —
| Source |
| ODE-274 | 2019-11-21 | 2026-11-21 | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) | N | N | — | ODE-175 + ODE-274 + I-960 + D-200
Full coverage date: —
| Source |
| ODE-274 | 2019-11-21 | 2026-11-21 | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) | N | N | — | ODE-175 + ODE-274 + I-960 + D-200
Full coverage date: —
| Source |
| I-960 | 2025-01-16 | 2028-01-16 | IN COMBINATION WITH BENDAMUSTINE AND RITUXIMAB FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED MANTLE CELL LYMPHOMA (MCL) WHO ARE INELIGIBLE FOR AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT) | N | N | — | ODE-175 + ODE-274 + I-960 + D-200
Full coverage date: —
| Source |
| I-960 | 2025-01-16 | 2028-01-16 | IN COMBINATION WITH BENDAMUSTINE AND RITUXIMAB FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED MANTLE CELL LYMPHOMA (MCL) WHO ARE INELIGIBLE FOR AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT) | N | N | — | ODE-175 + ODE-274 + I-960 + D-200
Full coverage date: —
| Source |
| D-200 | 2026-02-19 | 2029-02-19 | USE WITH VENETOCLAX AS A NEW COMBINATION REGIMEN FOR THE TREATMENT OFADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA | N | N | — | ODE-175 + ODE-274 + I-960 + D-200
Full coverage date: —
| Source |
| D-200 | 2026-02-19 | 2029-02-19 | USE WITH VENETOCLAX AS A NEW COMBINATION REGIMEN FOR THE TREATMENT OFADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA | N | N | — | ODE-175 + ODE-274 + I-960 + D-200
Full coverage date: —
| Source |
2026-10-11 · CURRENT_AND_HISTORICAL_RECORDS · Historical coverage: NOT_COMPLETE
2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| 216775 / 001 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | ALEMBIC PHARMS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
Market Entry Information
API filings, authorized generics and linked regulatory milestones.
API Master Files & Certifications 0 records
Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.
| API | Holder / manufacturer | Holder country | Filing type | Number | Status | Filed date | Available for reference | Source | Last verified |
|---|---|---|---|---|---|---|---|---|---|
| No master-file or certification records are linked through public manufacturer portfolios. | |||||||||
Authorized Generics 0 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No authorized-generic records are linked to this product. | ||||||
Tentative ANDA Approvals 0 records
Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.
| Application / product | Applicant | Event / status | Tentative date | Follow-up final approval | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|---|
| No tentative-approval records are linked to this product. | |||||||
Paragraph IV Challenges 0 records
Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.
| Application / product | Applicant | Event / status | Certification event date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No structured Paragraph IV certification events are linked in the available approval evidence. | ||||||
Final ANDA Approvals 0 records
Approval dates do not establish commercial launch. Product mapping is shown for each linked record.
| Application / product | Applicant | Event / status | Final approval date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No final-approval records are linked to this product. | ||||||
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| FINAL_REVIEW | — | ANCHOR_AND_TAIL | US10272083 claims 1 and 8 jointly cover CLL/SLL and MCL standard 100mg BID use; crystal-form tail remains through 2036-07-01. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2035 | DEEP_REVIEW | FINAL | 2035-01-21 | 2026-10-17 06:56:57 |
| N | 2032 | DEEP_REVIEW | FINAL | 2032-07-11 | 2026-10-11 18:11:30 |
Independent legal-event information
Litigation & Settlement History
Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.
No litigation or settlement record currently linked to this product.