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CALQUENCE

NDA

ACALABRUTINIB | N210259 | ASTRAZENECA UK LTD

1 strength9 unique patents3 unique exclusivities

Patent Timeline

9 unique patents, 3 exclusivities by expiration date

Expiring < 1yr (1)Active (8)TodayExclusivityIPRPTAB Challenge

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Nov. 24, 2026

Jul. 11, 2032

Jul. 11, 2032

Jul. 1, 2036

Jul. 1, 2036

Jul. 11, 2032

Jan. 21, 2035IPR

Aug. 11, 2035

Jan. 21, 2035

ODE-274

Nov. 21, 2026

I-960

Jan. 16, 2028

D-200

Feb. 19, 2029

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2023-00478	10272083	IPR	Sandoz Inc.	Institution Denied	2023-02-03	2023-08-07

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

6 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Acerta Pharma B.V. et al v. Sandoz Inc. 1:2022cv00164 7 patentsANDA 216405acalabrutinib	D. Del.	2022-02-04	Terminated 2024-03-19	—
Acerta Pharma B.V. et al v. Cipla Limited et al 1:2022cv00162	D. Del.	2022-02-04	Terminated 2024-06-13	—
Acerta Pharma B.V. et al v. MSN Pharmaceuticals Inc., et al. 1:2022cv00163	D. Del.	2022-02-04	Terminated 2024-07-15	—
Acerta Pharma B.V. et al v. Cipla Limited et al. 1:2022cv00154	D. Del.	2022-02-02	Terminated 2024-07-15	—
Acerta Pharma B.V. et al v. Natco Pharma Limited et al 1:2022cv00155	D. Del.	2022-02-02	Terminated 2024-04-16	—
Acerta Pharma B.V. et al v. Pharmacyclics LLC et al 1:2018cv00581 1 patentibrutinib	D. Del.	2018-04-18	Terminated 2019-10-23	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

58 trials from ClinicalTrials.gov — 7 recruiting, 22 active, 21 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia NCT04075292	Phase 3	Active	AstraZeneca	155	2020-01-20 → 2027-01-01
A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy NCT02717611	Phase 2	Active	Acerta Pharma BV	60	2016-03-08 → 2026-06-06
A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL NCT02717624	Phase 1	Active	Acerta Pharma BV	72	2016-04-20 → 2027-08-20
Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL NCT03863184	Phase 2	Active	Weill Medical College of Cornell University	37	2019-10-11 → 2028-05-30
Venetoclax and Acalabrutinib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma NCT03946878	Phase 2	Active	M.D. Anderson Cancer Center	32	2019-08-13 → 2028-02-08
A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma NCT04115631	Phase 2	Active	ECOG-ACRIN Cancer Research Group	360	2019-12-13 → 2026-12-31
Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)NCT02477696	Phase 3	Active	Acerta Pharma BV	533	2015-07-28 → 2028-01-03
An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia NCT02180724	Phase 2	Active	Acerta Pharma BV	107	2014-09-11 → 2026-12-31
A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)NCT03328273	Phase 1	Active	Acerta Pharma BV	12	2018-01-31 → 2026-08-26
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL NCT02972840	Phase 3	Active	Acerta Pharma BV	635	2017-04-05 → 2027-02-15

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data across 2 drug listings matched to this application (2024)

Calquence — Acalabrutinib Maleate (2024)

Total Spending

$1.7B

Total Claims

122,356

Beneficiaries

15,056

Avg Cost/Unit

$248.67

Spending Trend

$164.4M(2022)→$1.3B(2023)→$1.7B(2024)

YoY Change:-2.9%

5yr CAGR:-0.4%

Calquence — Acalabrutinib (2024)

Total Spending

$564K

Total Claims

Beneficiaries

Avg Cost/Unit

$231.11

Spending Trend

$103.9M(2019)→$350.0M(2020)→$774.7M(2021)→$1.0B(2022)→$59.8M(2023)→$564K(2024)

YoY Change:-9.1%

5yr CAGR:-0.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs

5 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDACALABRUTINIB

DMF 355582021

MSN LABORATORIES PRIVATE LTDACALABRUTINIB [ROUTE CODE HU]

DMF 357572021

CIPLA LTDACALABRUTINIB

DMF 357622021

ALEMBIC PHARMACEUTICALS LTDACALABRUTINIB

DMF 360292021

NATCO PHARMA LTDACALABRUTINIB DIHYDRATE

DMF 362632021

CHENGDA PHARMACEUTICALS CO LTDACALABRUTINIB INTERMEDIATE (CAS NO.: 1420478-88-1)

DMF 428002025

CHENGDA PHARMACEUTICALS CO LTDACALABRUTINIB INTERMEDIATE (CAS NO.: 850568-25-1)

DMF 428012025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Feb 23, 2026	SUPPL -12	View Letter (PDF)
Jan 17, 2025	SUPPL -11	View Letter (PDF)
Jul 2, 2024	SUPPL -10	View Letter (PDF)
Mar 25, 2022	SUPPL -9	View Letter (PDF)
Nov 22, 2019	SUPPL -7	View Letter (PDF)
Nov 22, 2019	SUPPL -6	View Letter (PDF)
Oct 31, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

RLD

9 patents3 exclusivities▴

CAPSULE;ORAL | Approved: Oct 31, 2017

Patents (9) · 42 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7459554	Nov 24, 2026	—	Yes	—	—	—
9290504	Jul 11, 2032	—	Yes	Yes	—	—
9758524	Jul 11, 2032	—	—	—		—
9796721	Jul 1, 2036	—	Yes	Yes		—
10167291	Jul 1, 2036	—	—	Yes		—
10239883	Jul 11, 2032	—	—	—		—
10272083	Jan 21, 2035	—	—	—		—
11166951	Aug 11, 2035	—	—	—		—
11771696	Jan 21, 2035	—	—	—		—

Exclusivities (3)

Code	Date	Status
D-200	Feb 19, 2029	Active
I-960	Jan 16, 2028	Active
ODE-274	Nov 21, 2026	< 1 year