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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

2 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. 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

3 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma NCT04257578	Phase 1/2	Active	University of Washington	23	2020-12-02 → 2031-03-01
Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma NCT03516617	Phase 2	Recruiting	Mayo Clinic	120	2018-09-10 → 2030-10-16
A Phase 1 Study of Acalabrutinib in Japanese Adult Patients With Advanced B-cell Malignancies NCT03198650	Phase 1	Completed	AstraZeneca	35	2017-06-27 → 2025-09-25

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

Medicare Part D Spending

CMS annual spending data for Calquence (2023)

Total Spending

$1.3B

Total Claims

89,978

Beneficiaries

12,390

Avg Cost/Unit

$255.96

Spending Trend

$103.9M(2019)→$350.0M(2020)→$774.7M(2021)→$1.0B(2022)→$164.4M(2022)→$1.3B(2023)→$59.8M(2023)

YoY Change:+2.2%

5yr CAGR:+2.2%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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	—	—	—	U-4426	—
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