acalabrutinib maleate - Profile

What are the generic sources for acalabrutinib maleate and what is the scope of freedom to operate?

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.

Summary for acalabrutinib maleate

International Patents:	192
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for acalabrutinib maleate

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

Constraining patent/regulatory exclusivity:

11,059,829

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.

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	10,272,083
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	11,059,829		Y	Y
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	9,758,524
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	11,771,696
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	10,239,883
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	7,459,554			Y

International Patents for acalabrutinib maleate

Country	Patent Number	Title	Estimated Expiration
Serbia	62760	4-IMIDAZOPIRIDAZIN-1-IL-BENZAMIDI I 4-IMIDAZOTRIAZIN-1-IL-BENZAMIDI KAO INHIBITORI BTK (4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDES AND 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDES AS BTK-INHIBITORS)
Canada	2841886
Malaysia	193514	SOLID FORMS AND FORMULATIONS OF (S)-4-(8-AMINO-3-(1-(BUT-2-YNOYL)PYRROLIDIN-2-YL)IMIDAZO[1, 5-A]PYRAZIN-1-YL)-N-(PYRIDIN-2-YL)BENZAMIDE
Morocco	57556	Formes et formulations solides de (s)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-n-(pyridin-2-yl)benzamide
Mexico	2020014163	FORMAS SOLIDAS Y FORMULACIONES DE (S)-4-(8-AMINO-3-(1-(BUT-2-INOIL )PIRROLIDIN-2-IL)IMIDAZO [1,5-A]PIRAZIN-1-IL)-N-(PIRIDIN-2-IL)BENZ AMIDA. (SOLID FORMS AND FORMULATIONS OF (S)-4-(8-AMINO-3-(1 -(BUT-2-YNOYL)PYRROLIDIN-2-YL)IMIDAZO[1,5-A]PYRAZIN-1-YL)-N-(PY RIDIN-2-YL)BENZAMIDE.)
Portugal	2734522

Supplementary Protection Certificates for acalabrutinib maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2734522	21C1014	France		PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/20/1479 20201106
2734522	PA2021004,C2734522	Lithuania		PRODUCT NAME: AKALABRUTINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/20/1479/001-EU/1/20/1479/002 20201105
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	C202130014	Spain		PRODUCT NAME: ACALABRUTINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1479; DATE OF AUTHORISATION: 20201105; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1479; DATE OF FIRST AUTHORISATION IN EEA: 20201105
2734522	LUC00202	Luxembourg		PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106
2734522	122021000020	Germany		PRODUCT NAME: ACALABRUTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1479 20201105

Acalabrutinib Maleate: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

Acalabrutinib maleate, marketed under the brand name Calquence, is a selective Bruton’s tyrosine kinase (BTK) inhibitor used to treat certain hematologic malignancies, notably mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and Waldenström’s macroglobulinemia (WM). As a second-generation BTK inhibitor developed by AstraZeneca, acalabrutinib offers enhanced selectivity and potentially a better safety profile compared to first-generation agents like ibrutinib.

The drug’s market trajectory is influenced by increasing indications, competitive landscape, patent protections, and broader shifts toward targeted cancer therapies. Investment in acalabrutinib involves assessing market growth potential, patent timelines, regulatory approvals, and competitive pressures.

This analysis explores the drug’s market dynamics, projected financial performance, and strategic considerations for investors between 2023 and 2030.

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Market Overview and Demand Drivers

Parameter	Details
Therapeutic Area	Hematologic malignancies: CLL, MCL, WM
Market Size (2022)	Estimated $4.8 billion globally (per IQVIA)
Projected CAGR (2023-2030)	8.5% (Reference: EvaluatePharma forecasts)
Market Expansion Factors	Increasing diagnosis rates, broader indications approval, combination therapies, aging populations
Key Competitors	Ibrutinib (Imbruvica), Zanubrutinib (Brukinsa), Acalabrutinib (Calquence)

Demand Drivers:

• Increased diagnoses of hematologic cancers, particularly in aging populations.
• Regulatory approvals expanding indications: FDA and EMA approvals for additional lines of therapy.
• Shift to targeted therapies, reducing reliance on chemoimmunotherapy.
• Combination therapy development, enhancing efficacy (e.g., with rituximab, venetoclax).

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Patent and Regulatory Landscape

Key Patent Milestones	Details	Expiry Estimates
Original Patent Filing	AstraZeneca, 2010	-
Primary Composition Patent	Expected expiry 2027 (US/Europe)	2027
Supplemental Patents & Methods of Use	Extend patent life through additional claims	2028-2030 (projected)
Regulatory Approvals	FDA (2019 for CLL/SLL, expanded 2020+), EMA	Approved in US, EU, Japan

Patent exclusivity supports market dominance until mid-2020s, with potential for generic entry thereafter.

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Financial Trajectory and Revenue Projections

Parameter	2023	2025	2030
Global Sales (USD millions)	$1,200	$2,500	$4,500+
Market Share (BTK inhibitors)	22%	30%	35%
Growth Rate (CAGR)	~8%

Note: Based on EvaluatePharma data, with conservative estimates accounting for patent expiry and competitive pressures.

Revenue Breakdown by Indication

Indication	2023 (USD Millions)	2025 (USD Millions)	2030 (USD Millions)
CLL/SLL	$650	$1,350	$2,300
MCL	$350	$700	$1,200
WM	$200	$400	$700
Others (combination, expanded uses)	$0	$50	$300

Cost and Profitability Assumptions

• R&D Investment: ~$250 million annually.
• Manufacturing & Distribution: Marginal costs ~20% of revenue.
• Pricing: US price approximately $10,000/month (per patient), with discounts and insurance adjustments.

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Competitive Landscape Analysis

Company	Drug Name	Market Share (2022)	Unique Selling Point
AstraZeneca	Calquence	~22%	Selective BTK targeting, favorable safety
Pharmacyclics	Imbruvica	~54%	First-in-class BTK inhibitor, broader indications
BeiGene	Zanubrutinib	~12%	Balances efficacy and safety, competitive pricing
Others	Orelabrutinib	<2%	Emerging pipeline, China-focused

Key Factors Influencing Competition:

• Efficacy and safety profiles.
• Indication expansion.
• Pricing strategies.
• Patent status and generics.

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Investment Considerations

Strengths

• Growing market: Hematologic cancers continue to expand, with untapped potential in early lines and combination regimens.
• Regulatory coverage: Established approvals with ongoing label expansions.
• Favorable safety profile: Differentiates acalabrutinib from ibrutinib, influencing treatment adherence.

Risks

• Patent expiry risk: Generic entry post-2027 may erode revenue.
• Competitive pressures: Zanubrutinib gaining market share; other pipeline agents emerging.
• Regulatory challenges: Expansion into new indications may face delays or rejection.
• Pricing pressures: Healthcare systems emphasizing cost containment.

Strategic Opportunities

• Combination therapies: Collaborations for combination use (e.g., with venetoclax, obinutuzumab).
• Geographic expansion: Growing markets in Asia, Latin America.
• Biomarker development: Precision medicine approaches enhancing treatment efficacy.

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Comparative Performance of BTK Inhibitors

Parameter	Acalabrutinib	Ibrutinib	Zanubrutinib
Target Selectivity	High (second generation)	Moderate	High
Adverse Event Profile	Favorable	Higher atrial fibrillation, bleeding	Similar to acalabrutinib
FDA Approvals	2019 (CLL, MCL)	2013	2019 (China)
Indication Expansion	Yes	Yes	Yes

Deep Dive into Key Drivers and Risks

Drivers

• Medical need: Resistance and tolerability issues with earlier therapies sustain growth.
• Clinical Trials: Promising Phase III data in multiple indications bolster future approvals.
• Market consolidation: Pharma alliances and M&A activities could accelerate market penetration.

Risks

• Patent Interference: Patent challenges or invalidations may accelerate generic entry.
• Regulatory delays: Approvals for new indications or combination therapies might be postponed.
• Price erosion: Increased competition and payor negotiations pressure margins.

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Summary Chart: Investment Outlook Timeline (2023–2030)

Year	Market Growth	Revenue Estimate (USD millions)	Key Milestones
2023	8%	$1,200	US approval for expanded indications
2025	8.5%	$2,500	Patent coverage ongoing; clinical trial data
2027	Closing patent window	$3,200	Patent expiry, generic emergence risk
2030	Stable growth, competitive positioning	$4,500+	Market maturity, pipeline output

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Key Takeaways

• Acalabrutinib maleate’s market potential remains robust, driven by expanding indications, favorable safety profile, and targeted therapy trends.
• Patent expiration around 2027 presents an inflection point, risking revenue erosion unless new indications or formulations are developed.
• Competitive landscape is intensifying; differentiation hinges on efficacy, safety, and combination strategy.
• Pricing strategies, geographic expansion, and pipeline innovation are critical to maintaining financial trajectory.
• Investors should monitor regulatory developments, patent status, and competitive entry timelines closely.

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Frequently Asked Questions

1. What is the current patent status for acalabrutinib?
   The primary composition patent is expected to expire in 2027, with supplemental patents extending patent life to 2028-2030, after which generic competition may emerge.

2. How does acalabrutinib compare with ibrutinib?
   Acalabrutinib demonstrates higher selectivity and a better safety profile, notably fewer atrial fibrillation events, which could translate into better adherence and outcomes.

3. What are the key indications approved for acalabrutinib?
   FDA-approved indications include treatment of mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and Waldenström’s macroglobulinemia (WM).

4. What are the main risks affecting the drug’s market performance?
   Patent expiry, increased competition from zanubrutinib and pipeline agents, regulatory challenges in indication expansion, and pricing pressures.

5. What strategic moves could prolong acalabrutinib’s market dominance?
   Developing combination therapies, expanding into new geographic markets, pursuing additional indications, and sustaining innovation through pipeline research.

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References

1. EvaluatePharma. "Global Hematologic Cancer Market Forecast," 2022.
2. AstraZeneca. "Calquence Prescribing Information," 2022.
3. IQVIA. "Global Oncology Market Data," 2022.
4. U.S. Food and Drug Administration. "Drug Approvals and Indications," 2019–2022.
5. European Medicines Agency. "Calquence Marketing Authorization Summary," 2020.

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Note: All projections are estimates based on current data and market trends; actual future performance may vary based on regulatory, competitive, and clinical development factors.