Acalabrutinib - Generic Drug Details

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

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

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

There are two tentative approvals for this compound.

Summary for acalabrutinib

International Patents:	192
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	156
Patent Applications:	4,644
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for acalabrutinib
What excipients (inactive ingredients) are in acalabrutinib?	acalabrutinib excipients list
DailyMed Link:	acalabrutinib at DailyMed

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

Dosage:

CAPSULE;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.

Recent Clinical Trials for acalabrutinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute (NCI)	PHASE1
City of Hope Medical Center	PHASE1
VA Office of Research and Development	PHASE2

See all acalabrutinib clinical trials

Generic filers with tentative approvals for ACALABRUTINIB

Applicant	Application No.	Strength	Dosage Form
		100MG	CAPSULE;ORAL
		100MG	CAPSULE

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for acalabrutinib

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CALQUENCE	Capsules	acalabrutinib	100 mg	210259	5	2021-11-01

US Patents and Regulatory Information for acalabrutinib

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
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
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes

EU/EMA Drug Approvals for acalabrutinib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AstraZeneca AB	Calquence	acalabrutinib	EMEA/H/C/005299Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.	Authorised	no	no	no	2020-11-05

International Patents for acalabrutinib

Country	Patent Number	Title	Estimated Expiration
Finland	3954690
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
Mexico	2018000179	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.)
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

Supplementary Protection Certificates for acalabrutinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2734522	C20210006 00368	Estonia		PRODUCT NAME: AKALABRUTINIIB;REG NO/DATE: EU/1/20/1479 06.11.2020
2734522	2021016	Norway		PRODUCT NAME: AKALABRUTINIB; REG. NO/DATE: EU/1/20/1479 20201111
2734522	2190009-7	Sweden		PRODUCT NAME: ACALABRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1479 20201106
2734522	C02734522/01	Switzerland		PRODUCT NAME: ACALABRUTINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67790 04.03.2021

Market Dynamics and Financial Trajectory for ACALABRUTINIB

Last updated: October 15, 2025

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Introduction

Acalabrutinib, marketed as Calquence by AstraZeneca, represents a significant advancement in targeted cancer therapeutics, specifically for B-cell malignancies such as chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). As a second-generation Bruton's tyrosine kinase (BTK) inhibitor, it benefits from a more selective profile than its predecessor, ibrutinib, leading to improved safety and tolerability. Understanding the market dynamics and financial trajectory of acalabrutinib is vital for stakeholders evaluating its commercial potential and competitive landscape.

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Market Overview

1. Therapeutic Indication and Unmet Needs

Acalabrutinib is approved primarily for CLL and MCL. The global incidence of CLL exceeds 160,000 cases annually [1], with a rising prevalence attributed to aging populations. MCL, accounting for about 3-10% of non-Hodgkin lymphomas, also exhibits significant unmet medical needs due to limited durable treatment options [2].

The advent of BTK inhibitors has revolutionized treatment paradigms, offering oral administration, targeted mechanisms, and improved outcomes. Nevertheless, issues like resistance, adverse effects, and disease relapse create ongoing demand for next-generation agents such as acalabrutinib.

2. Competitive Landscape

Key competitors include ibrutinib (Imbruvica), zanubrutinib (Brukinsa), and other emerging BTK inhibitors. Despite ibrutinib's widespread use, its off-target effects prompted development of more selective drugs like acalabrutinib, positioning it favorably in terms of safety profile.

Additionally, combination strategies incorporating acalabrutinib with anti-CD20 antibodies and other agents are under clinical evaluation, potentially expanding its indications and market penetration [3].

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Market Dynamics

1. Regulatory Approvals and Regional Penetration

Acalabrutinib received FDA approval in 2019 for CLL/SLL and in 2020 for MCL. Its approval in Europe and other regions followed, facilitated by clinical trial data demonstrating comparable or superior efficacy with better tolerability relative to ibrutinib.

Regional regulatory dynamics influence market access. While North America and Europe already demonstrate high adoption, emerging markets' access depends on pricing, reimbursement policies, and healthcare infrastructure.

2. Pricing and Reimbursement

Pricing strategies for acalabrutinib are aligned with premium targeted therapies, often justified through superior safety profiles and convenience. Reimbursement decisions rest heavily on comparative effectiveness and cost-benefit analyses.

In the US, Calquence's list price is approximately $11,000 per month [4]. Payer coverage has been generally favorable for patients qualifying under guidelines, but price sensitivity persists, especially in markets with constrained healthcare budgets.

3. Market Penetration and Adoption

Physician familiarity and clinical evidence influence adoption. Real-world data suggest increasing utilization, with evolving guidelines endorsing acalabrutinib as a first-line treatment option for certain CLL patients, particularly those who are frail or intolerant to ibrutinib.

The drug's safety profile fosters patient adherence, a critical factor for achieving durable responses. Market share analyses indicate that acalabrutinib is gradually gaining ground, though ibrutinib retains a stronghold due to early market entry, established pipeline, and established physician experience [5].

4. Clinical Pipeline and Future Indications

Ongoing trials evaluate acalabrutinib's efficacy in other hematologic malignancies and solid tumors, such as Waldenström's macroglobulinemia and chronic graft-versus-host disease. Success in these areas could augment revenue streams and extend market lifecycle.

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Financial Trajectory

1. Revenue Dynamics

AstraZeneca's fiscal reports demonstrate a steadily growing revenue contribution from Calquence, with global sales in the hundreds of millions USD [6]. Sales accelerated following FDA approval for MCL and expanded clinical uses, with global sales surpassing $750 million in 2022.

Revenue growth correlates with increasing patient penetration, especially in key markets. The company’s ability to expand indications and maintain competitive pricing influences future earnings.

2. Market Penetration Strategies

AstraZeneca invests in scientific collaborations, physician education, and patient access programs. These initiatives bolster prescriber confidence and expand the drug's reach. Pricing strategies are tailored regionally, balancing access and profitability.

3. Cost Structure and Investment

Development costs for acalabrutinib, including clinical trials and regulatory submissions, are substantial but amortized over the product lifecycle. Continued investments in clinical research and post-marketing surveillance are expected, aiming to optimize use cases and patient outcomes.

4. Competitive Threats and Patent Landscape

Patent exclusivity until 2030-2035 in key territories grants a period of market protection. However, biosimilar and generic competition, as well as potential emerging therapies, could pressure margins.

Nota bene: Patent litigation and licensing agreements influence longevity and revenue forecasts.

5. Long-term Outlook

Projected compound annual growth rate (CAGR) for acalabrutinib sales ranges from 10% to 15% over the next five years, driven by expanding indications, geographic penetration, and combination therapies. The anticipated decline in generic competition post-patent expiry underscores a positive long-term financial trajectory.

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Market Challenges and Opportunities

Challenges:

• Competition from zanubrutinib and other BTK inhibitors.
• Resistance development and adverse event limitations.
• Reimbursement hurdles in emerging markets.
• Regulatory and clinical trial risks in expanding indications.

Opportunities:

• Combination regimens with other targeted therapies.
• Expanding indications into solid tumors or autoimmune diseases.
• Global market expansion, especially into Asia-Pacific regions.
• Real-world evidence supporting enhanced safety and efficacy.

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Conclusion

Acalabrutinib's market dynamics reflect a robust growth trajectory coupled with strategic positioning as a safer, selective BTK inhibitor. Its financial outlook appears promising, contingent on continued clinical success, regulatory approvals, and market access strategies. The evolving landscape of B-cell malignancy treatment encourages ongoing innovation, with acalabrutinib poised to capture incremental market share through dedicated scientific and clinical efforts.

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Key Takeaways

• Acalabrutinib’s targeted profile provides a competitive advantage, bolstering its adoption in CLL and MCL treatment.
• Regulatory approvals, reimbursement policies, and physician confidence are pivotal in expanding market penetration.
• Revenue growth is driven by regional expansion, additional indications, and adoption in combination therapies.
• Patent protections and clinical trial advancements will shape the product’s long-term financial sustainability.
• Strategic investments in research and geographic expansion are crucial for maintaining competitive advantage.

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FAQs

1. What distinguishes acalabrutinib from earlier BTK inhibitors?
Acalabrutinib offers improved selectivity for BTK, reducing off-target effects, which translates to a better safety profile—particularly fewer occurrences of atrial fibrillation, bleeding, and diarrhea—compared to ibrutinib.

2. How does the market outlook for acalabrutinib compare to its competitors?
Acalabrutinib is positioned as a superior safety alternative, gaining preference among clinicians. Its growth hinges on its clinical performance and approval for broader indications, though competitors like zanubrutinib are also strengthening their positions.

3. Which regions are most critical for acalabrutinib’s growth?
North America remains the primary market due to high approval rates and healthcare infrastructure. Europe is significant, with emerging opportunities in Asia-Pacific and Latin America where access expands.

4. What factors influence acalabrutinib’s pricing and reimbursement strategies?
Therapeutic efficacy, safety profile, competitive landscape, healthcare policies, and negotiations with payers influence pricing. Demonstrated cost-effectiveness supports favorable reimbursement decisions.

5. What future developments could impact acalabrutinib’s market share?
Emerging data on combination therapy efficacy, new indications, and potential generics post-patent expiry could affect its dominance. Additionally, breakthroughs in alternative modalities or resistance mechanisms could reshape market dynamics.

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Sources:

[1] American Cancer Society. "Cancer Facts & Figures 2022."
[2] National Cancer Institute. "Mantle Cell Lymphoma."
[3] ClinicalTrials.gov. "Acalabrutinib in combination therapies."
[4] GoodRx. "Cost of Calquence (acalabrutinib)."
[5] EvaluatePharma. "BTK inhibitor market report."
[6] AstraZeneca Annual Reports, 2022.