Acalabrutinib maleate - Generic Drug Details

What are the generic sources for acalabrutinib maleate and what is the scope of patent protection?

Acalabrutinib maleate is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acalabrutinib maleate has one hundred and ninety-two patent family members in fifty countries.

One supplier is listed for this compound.

Summary for acalabrutinib maleate

International Patents:	192
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for acalabrutinib maleate
DailyMed Link:	acalabrutinib maleate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for acalabrutinib maleate

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for acalabrutinib maleate

Drug Class	Kinase Inhibitor
Mechanism of Action	Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for acalabrutinib maleate

L01EL	Bruton's tyrosine kinase (BTK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for ACALABRUTINIB MALEATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CALQUENCE	Tablets	acalabrutinib maleate	100 mg	216387	1	2024-02-13

US Patents and Regulatory Information for acalabrutinib maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes			Y	Y
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes				Y
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes

International Patents for acalabrutinib maleate

Country	Patent Number	Title	Estimated Expiration
Ukraine	115312	4-ІМІДАЗОПІРИДАЗИН-1-ІЛБЕНЗАМІДИ І 4-ІМІДАЗОТРИАЗИН-1-ІЛБЕНЗАМІДИ ЯК ВТК-ІНГІБІТОРИ (4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDES AND 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDES AS BTK- INHIBITORS)
Israel	291489	הכנה של (s)-4-(8-אמינו-3-(1-בוט-2-ינוייל-פירולידינ-2-יל) אימידאזו [5,1-a]פיראזינ-1-יל)-n-(פירידינ-2-יל)בנזאמיד ומלחים רוקחיים מקובלים שלו (Preparation of (s)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl) imidazo [1,5-a]pyrazin-1-yl)-n-(pyridin-2-yl)benzamide and pharmaceutically acceptable salts thereof)
Mexico	342983	4-IMIDAZOPIRIDAZIN-1-IL-BENZAMIDAS Y 4-IMIDAZOTRIAZIN-1-IL BENZAMIDAS COMO INHIBIDORES DE TIROSINA CINASA DE BRUTON. (4 - IMIDAZOPYRIDAZIN- 1 -YL-BENZAMIDES AND 4 - IMIDAZOTRIAZIN- 1 - YL - BENZAMIDES AS BTK- INHIBITORS.)
Canada	2991096

Supplementary Protection Certificates for acalabrutinib maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2734522	C02734522/01	Switzerland		PRODUCT NAME: ACALABRUTINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67790 04.03.2021
2734522	132021000000047	Italy		PRODUCT NAME: ACALABRUTINIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(CALQUENCE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1479, 20201106
2734522	12/2021	Austria		PRODUCT NAME: 4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDE UND 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDE ALS BTK-INHIBITOREN; REGISTRATION NO/DATE: EU/1/20/1479 (MITTEILUNG) 20201106
2734522	2021C/512	Belgium		PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Acalabrutinib Maleate

Last updated: July 27, 2025

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Introduction

Acalabrutinib maleate, marketed under brand names such as Calquence by AstraZeneca, is a selective Bruton’s tyrosine kinase (BTK) inhibitor approved for the treatment of various B-cell malignancies, including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL). Its strategic positioning relies on its targeted mechanism, favorable safety profile, and expanding clinical applications. The following analysis explores the market dynamics and financial trajectory shaping the future of acalabrutinib maleate within the oncology and hematology sectors.

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Market Landscape and Growth Drivers

1. Rising Incidence of B-cell Malignancies

The global prevalence of B-cell malignancies has increased steadily, driven by aging populations and improved diagnostic techniques. According to Globocan 2020, non-Hodgkin lymphomas (NHL), including CLL and MCL, account for significant oncology burdens, with over 545,000 new cases annually worldwide. The demand for effective, oral targeted therapies like acalabrutinib has grown correspondingly, positioning the drug as a key component in treatment regimens.

2. Competitive Edge: Selectivity and Safety Profile

Acalabrutinib distinguishes itself from earlier BTK inhibitors such as ibrutinib through enhanced selectivity, reducing off-target effects like atrial fibrillation and bleeding risks. This safety advantage has influenced prescribing practices, especially among elderly and comorbid populations, expanding its market potential.

3. Expanding Indications and Clinical Trials

Regulatory approvals initially secured for CLL/SLL have paved the way for broader indications including MCL and follicular lymphoma. Ongoing clinical trials aim to evaluate acalabrutinib in combination therapies, first-line settings, and additional hematological and solid tumors. Positive trial outcomes could significantly expand its label and patient base.

4. Strategic Collaborations and Market Penetration Efforts

Partnerships with healthcare providers and payers have facilitated market entry and reimbursement frameworks. AstraZeneca's global footprint and focused marketing have accelerated adoption, particularly in North America and Europe, where the drug is already approved and reimbursed efficiently.

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Market Challenges and Barriers

1. Patent Protections and Competition

While acalabrutinib's patents safeguard its market exclusivity until approximately 2030, generic and biosimilar entrants are anticipated as patent expiry approaches. Competitors like ibrutinib (Imbruvica) and newer BTK inhibitors with comparable or superior efficacy could erode market share.

2. Price Sensitivity and Market Access

Therapeutic pricing influences market penetration, especially in emerging economies with constrained healthcare budgets. Reimbursement challenges and value-based pricing discussions impact acalabrutinib's financial trajectory.

3. Regulatory and Clinical Uncertainties

Evolving regulatory landscapes, particularly regarding combination therapies and expanded indications, introduce uncertainties. Clinical trial results supporting efficacy and safety are critical in securing approvals for off-label uses.

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Financial Trajectory and Revenue Projections

1. Revenue Growth Trends

Since its FDA approval in 2019, acalabrutinib has experienced rapid uptake. AstraZeneca reported revenues of approximately $0.8 billion globally in 2022 attributable to Calquence, registering a compound annual growth rate (CAGR) of roughly 22% since launch (2020–2022). Market penetration is especially strong in North America, accounting for around 75% of sales.

2. Forecasting Future Earnings

Analysts project that by 2025, global sales could exceed $2 billion, driven by indications expansion, increasing adoption, and potential first-line approvals. The uptake rate could accelerate with positive clinical trials and expanded labeling, especially if combination regimens demonstrate superior efficacy.

3. R&D and Pipeline Investment Impact

AstraZeneca’s continuous R&D investment, estimated at over $7 billion annually globally, supports acalabrutinib’s development pipeline, including next-generation BTK inhibitors and novel combinations. These investments are expected to reinforce long-term revenues through expanded indications and improved formulations.

4. Pricing Strategies and Market Penetration

Pricing varies across regions, with US list prices for Calquence ranging from $9,850 to $10,860 per month per patient, depending on indications and dosage. Strategic tiered pricing and patient access programs are employed to improve affordability, which could influence overall revenue generation.

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Regulatory and Commercial Outlook

The regulatory landscape remains supportive, with the FDA and EMA approving acalabrutinib for multiple hematologic malignancies. Ongoing submissions for additional indications, including front-line therapy in CLL, could lead to accelerated market expansion. Alliances with local distributors and payers will be instrumental in capturing emerging markets, particularly in Asia-Pacific and Latin America.

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Competitive Environment and Differentiation

The BTK inhibitor class features prominent players such as ibrutinib (Imbruvica) and zanubrutinib (Brukinsa). While acalabrutinib’s superior safety profile is an advantage, the competition's established presence and clinician familiarity pose barriers. Future growth hinges on demonstrating clear clinical benefits and cost-effectiveness, especially as combination regimens gain prominence.

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Impact of Biosimilars and Patent Expiry

Patent protection is vital for revenue sustenance. Acalabrutinib’s patents expected to expire around 2030, with biosimilars and generics potentially entering the market shortly thereafter. Strategic patent management and early expansion into new indications can mitigate revenue erosion.

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Conclusion

Acalabrutinib maleate’s market dynamics are characterized by rapid growth fueled by an increasing burden of B-cell malignancies and a favorable safety profile. Strategic clinical trial progress, indication expansion, and effective market access initiatives will shape its financial trajectory. While competition and patent expiry pose risks, sustained R&D investment and robust clinical data will likely underpin its long-term revenue potential, especially in markets with high unmet needs.

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Key Takeaways

• Growing Market for B-cell Malignancies: Increasing incidence coupled with improved diagnostics enhances acalabrutinib's growth opportunity.
• Leadership through Safety and Specificity: Its favorable safety profile differentiates acalabrutinib from earlier BTK inhibitors.
• Expansion of Indications: Clinical trials and regulatory submissions for new indications could significantly boost revenues.
• Competitive Landscape: The presence of established rivals necessitates continued innovation and value demonstration.
• Patent and Market Access Risks: Patent expiry looming around 2030 underscores the need for pipeline diversification and lifecycle management.

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FAQs

Q1: What are the primary factors driving acalabrutinib's market growth?
A1: The key drivers include rising B-cell malignancy cases, its targeted safety profile, ongoing clinical trials for expanded indications, and strategic market access efforts.

Q2: How does acalabrutinib compare with other BTK inhibitors?
A2: Acalabrutinib offers higher selectivity with fewer off-target effects, leading to a better safety profile, especially in elderly or comorbid patients. However, its market share faces competition from more established BTK inhibitors like ibrutinib.

Q3: When will patent expiry impact acalabrutinib's revenue?
A3: Patent protections are expected to expire around 2030, after which biosimilars and generics could enter the market, posing a risk to revenue streams.

Q4: What future clinical developments could influence the financial outlook?
A4: Positive trial results for first-line use, combination therapies, and new indications could substantially expand its market potential and revenues.

Q5: How are reimbursement strategies affecting acalabrutinib's market penetration?
A5: Effective reimbursement policies and patient access programs in key markets facilitate broader adoption, bolstering sales and market share.

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References

1. Globocan 2020, International Agency for Research on Cancer.
2. AstraZeneca Annual Report 2022.
3. FDA Drug Approvals, 2019–2022.
4. Market Research Future, Hematology-oncology therapeutics market report, 2022.
5. ClinicalTrials.gov, ongoing studies involving acalabrutinib.