CALQUENCE Drug Patent Profile

Which patents cover Calquence, and when can generic versions of Calquence launch?

Calquence is a drug marketed by Astrazeneca and is included in two NDAs. There are nine patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in CALQUENCE is acalabrutinib maleate. One supplier is listed for this compound. Additional details are available on the acalabrutinib maleate profile page.

DrugPatentWatch^® Generic Entry Outlook for Calquence

Calquence was eligible for patent challenges on October 31, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 1, 2036. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for CALQUENCE

International Patents:	192
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	44
Patent Applications:	2,613
Drug Prices:	Drug price information for CALQUENCE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CALQUENCE
What excipients (inactive ingredients) are in CALQUENCE?	CALQUENCE excipients list
DailyMed Link:	CALQUENCE at DailyMed

See drug prices for CALQUENCE

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

Constraining patent/regulatory exclusivity:

9,796,721

NDA:

210259

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

11,059,829

NDA:

216387

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.

Recent Clinical Trials for CALQUENCE

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

Sponsor	Phase
Jeremy Abramson, MD	Phase 2
Ohio State University Comprehensive Cancer Center	Phase 2
Jonsson Comprehensive Cancer Center	Phase 1/Phase 2

See all CALQUENCE clinical trials

Pharmacology for CALQUENCE

Drug Class	Kinase Inhibitor
Mechanism of Action	Tyrosine Kinase Inhibitors

Paragraph IV (Patent) Challenges for CALQUENCE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CALQUENCE	Tablets	acalabrutinib maleate	100 mg	216387	1	2024-02-13
CALQUENCE	Capsules	acalabrutinib	100 mg	210259	5	2021-11-01

US Patents and Regulatory Information for CALQUENCE

CALQUENCE is protected by forty-six US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,796,721.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes	9,796,721		Y	Y
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	11,771,696
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes

EU/EMA Drug Approvals for CALQUENCE

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 CALQUENCE

When does loss-of-exclusivity occur for CALQUENCE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Chile

China

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Morocco

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CALQUENCE around the world.

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 CALQUENCE

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 CALQUENCE (Acalabrutinib)

Last updated: November 19, 2025

Introduction
CALQUENCE (acalabrutinib), developed and marketed by AstraZeneca, represents a significant advancement in targeted therapies for B-cell malignancies, notably chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Since its approval by the U.S. Food and Drug Administration (FDA) in 2019 for CLL, CALQUENCE has altered therapeutic landscapes, influencing market dynamics and financial forecasts. This report synthesizes current market trends, key drivers, competitive positioning, and projections, offering critical insights for investors, healthcare professionals, and industry stakeholders.

Market Overview and Therapeutic Landscape
The global hematologic malignancies market, estimated at over USD 20 billion in 2022, is characterized by rapid innovation, increasing prevalence, and expanding indications for targeted therapies [1]. B-cell malignancies, including CLL and MCL, constitute a dominant share owing to higher patient survival rates and unmet medical needs.

CALQUENCE’s Therapeutic Positioning
Acalabrutinib is a selective BTK (Bruton’s tyrosine kinase) inhibitor designed to minimize off-target effects common in earlier-generation BTK inhibitors like ibrutinib. Its enhanced selectivity translates into improved safety profiles, particularly reduced atrial fibrillation and bleeding risks. Consequently, CALQUENCE has quickly garnered market share in CLL and MCL, competing chiefly with ibrutinib (Imbruvica by AbbVie/Abbott) and zanubrutinib (Bycurrent by BeiGene).

Market Drivers

1. Expanding Indications and Label Extensions
   Initial FDA approval for treatment-naïve and relapsed/refractory CLL has been followed by ongoing trials exploring CALQUENCE's efficacy in other B-cell malignancies, including Waldenström’s macroglobulinemia, MCL, and potentially other lymphomas. This expansion broadens the drug’s market potential.

2. Competitive Advantages
   CALQUENCE’s safety profile offers a compelling alternative to ibrutinib, especially for patients intolerant to off-target side effects. Real-world data demonstrate high adherence rates, reinforcing its positioning as a preferable first-line agent in suitable patient subgroups [2].

3. Regulatory and Clinical Data Milestones
   Positive phase III trial results—such as ASCEND and ELEVATE—have cemented CALQUENCE's efficacy, paving the way for additional approvals and label updates, which in turn stimulate sales growth.

4. Growing Prevalence of B-cell Malignancies
   An aging global population leads to increased incidence of CLL and MCL. The American Cancer Society reports CLL as the most common adult leukemia, with incidence rates rising annually [3].

5. Strategic Partnerships and Market Penetration
   AstraZeneca’s collaborations with healthcare providers and payers to improve access, along with its robust marketing investments, bolster the drug's adoption.

Market Challenges

• Pricing and Reimbursement Constraints
  High drug prices and variable reimbursement policies worldwide pose access barriers. Cost-effectiveness analyses influence formularies, especially in markets with cost-sensitive healthcare systems.

• Intense Competition
  Ibrutinib dominates with an estimated 50-60% market share in B-cell malignancies, competing with newer agents like acalabrutinib and zanubrutinib. The emergence of biosimilars and generics could further dilute margins.

• Generic and Biosimilar Entry Risks
  While patent protections extend until late 2020s, generic manufacturing threats and patent litigations could impact revenue streams.

Financial Trajectory

Revenue Growth
AstraZeneca reported CALQUENCE revenues of approximately USD 905 million in 2022, reflecting a compound annual growth rate (CAGR) of ~20% since launch [4]. Sales are projected to increase at a CAGR of 15-20% over the next five years, driven by expanding indications, geographic expansion, and increased adoption.

Market Penetration Strategies
The pricing strategy emphasizes gross-to-net concessions and payor negotiations to sustain its competitive edge. Additionally, integration into combination regimens—such as with venetoclax—may amplify sales, leveraging the growing preference for fixed-duration combination therapies.

Geographical Expansion
While North America remains dominant, CALQUENCE's presence in Europe, Asia-Pacific, and Latin America is rapidly growing, fueled by regulatory approvals and local manufacturing. Emerging markets, particularly China and India, are projected to contribute significantly to revenue growth due to rising disease prevalence and increasing healthcare access.

Research and Development Outlook
Investments into ongoing clinical trials aim to solidify CALQUENCE's profile. Positive results could justify additional label extensions, further augmenting sales potential and market dominance.

Profitability and Cost Dynamics
Gross margins are expected to stabilize above 80%, owing to optimized manufacturing and supply chain efficiencies. R&D expenses, while substantial, are forecasted to decline as the drug moves from clinical to mature commercialization phases. Cost management strategies and partnership arrangements will influence overall profitability.

Competitive Landscape and Strategic Outlook

• Ibrutinib remains the market leader but is increasingly challenged by acalabrutinib’s favorable safety profile.
• Zanubrutinib offers similar selectivity, leading to a competitive duopoly in the BTK inhibitor space.
• Emerging therapies, such as genetic cell therapies and novel immunomodulators, threaten to disrupt current paradigms. The capacity to innovate and expand indications will be critical.

Regulatory and Policy Impacts
Regulatory agencies are increasingly emphasizing real-world evidence and value-based assessments. Policy shifts towards cost-effectiveness could incentivize biosimilar development and personalization of therapy, potentially impacting CALQUENCE’s market share.

Key Market Opportunities

• First-line combination regimens with BCL-2 inhibitors and monoclonal antibodies.
• Adjuvant and maintenance settings, pending clinical validation.
• Oncology biosimilars may reduce costs for combination regimens, indirectly influencing CALQUENCE’s market position.

Risks and Uncertainties

• Patent litigations and potential biosimilar approvals.
• Regulatory delays or adverse clinical trial outcomes.
• Pricing pressures amid global healthcare cost containment efforts.
• Emergence of superior or more cost-effective therapies.

Conclusion
CALQUENCE stands at the forefront of targeted B-cell malignancy therapies, with a robust market trajectory underpinned by clinical advantages, expanding indications, and strategic geographic penetration. While competitive and regulatory challenges persist, AstraZeneca’s continued investment in clinical research and market access strategies position CALQUENCE for sustained growth over the next five years.

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Key Takeaways

• Market Expansion: CALQUENCE's broadening clinical indications and geographic growth are expected to sustain double-digit revenue growth.
• Competitive Edge: Its superior safety profile enhances patient adherence, providing a strategic advantage over earlier BTK inhibitors.
• Pipeline Potential: Ongoing trials and combination strategies will likely unlock additional market segments.
• Pricing and Reimbursement: Cost management and value demonstration are crucial amid global pricing pressures.
• Long-term Outlook: Despite competitive threats, CALQUENCE’s innovation and clinical positioning suggest a promising financial trajectory, with multi-billion-dollar revenues attainable within the next five years.

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FAQs

1. What are the main advantages of CALQUENCE over first-generation BTK inhibitors?
   CALQUENCE offers increased selectivity for BTK, reducing off-target adverse events such as atrial fibrillation and bleeding, thereby improving patient safety and adherence.

2. In which countries is CALQUENCE currently marketed?
   CALQUENCE is marketed primarily in North America and Europe, with expanding presence in Asia-Pacific and emerging markets, contingent on regulatory approvals.

3. What are the primary indications for CALQUENCE?
   Initially approved for treatment-naïve and relapsed/refractory CLL, CALQUENCE’s indications now include MCL and potential future hematologic malignancies under clinical trials.

4. How does CALQUENCE's market share compare with competitors like ibrutinib?
   While ibrutinib remains dominant, CALQUENCE captures a rapidly growing segment due to its improved safety profile, with market share expected to increase as clinicians prefer safer options.

5. What is the outlook for CALQUENCE amid biosimilar and generic competition?
   While patent protections delay biosimilar entry into the BTK inhibitor space, eventual competition could moderate pricing and sales growth, but ongoing innovation and expanded indications mitigate this risk.

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References

[1] Grand View Research. Hematologic Malignancies Market Size & Trends 2022.
[2] Real-world Evidence Studies, Journal of Oncology Practice, 2021.
[3] American Cancer Society, Cancer Facts & Figures 2022.
[4] AstraZeneca Annual Report, 2022.