CALQUENCE Drug Patent Profile

Which patents cover Calquence, and what generic alternatives are available?

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 two hundred 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:	200
US Patents:	9
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CALQUENCE

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.

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
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes			Y	Y
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes

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
Spain	2904707
Australia	2016203837
Lithuania	3689878

Supplementary Protection Certificates for CALQUENCE

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

Investment Scenario, Market Dynamics, and Financial Trajectory for CALQUENCE (Acalabrutinib)

Last updated: February 3, 2026

Summary

CALQUENCE (acalabrutinib) is a Bruton’s tyrosine kinase (BTK) inhibitor developed by AstraZeneca for the treatment of B-cell malignancies. Since its FDA approval in 2019, CALQUENCE has experienced robust commercial traction, driven by expanding indications and favorable clinical outcomes. This report provides a comprehensive analysis of CALQUENCE’s current market landscape, future growth prospects, competitive positioning, and investment potential. Key data-driven insights include revenue forecasts, market share evolution, pipeline developments, and regulatory considerations.

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What Is the Current Market Position for CALQUENCE?

Approximate Revenue Generation (2022–2023)

Year	Global Sales (USD Billion)	Key Markets	Market Share in BTK Inhibitors
2022	$1.2	U.S., Europe, Japan	~25% (by revenue)
2023	$1.5 (projected)	Rising in China	~28%

Key Approved Indications and Clinical Use

• Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
• Mantle Cell Lymphoma (MCL)
• Potential future indications include other B-cell malignancies, with ongoing trials in multiple myeloma, Waldenström’s macroglobulinemia, and after resistance development to existing therapies.

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Market Dynamics Impacting CALQUENCE's Growth

Competitive Landscape

Competitor	Lead Indications	Market Share	Pipeline Status	Key Differentiator
Ibrutinib (Imbruvica, AbbVie + J&J)	CLL, MCL, Waldenström’s	~60% (2022)	Approved; some resistance issues	A broad spectrum, earlier market entry
Zanubrutinib (Brukinsa, BeiGene)	CLL, MCL	~10%	Growing	Higher selectivity, fewer bleeding events
Acalabrutinib (CALQUENCE)	CLL, MCL	~10–15%	Expanding approvals	Higher specificity, potentially fewer adverse effects

Market Penetration and Adoption Drivers

• Regulatory approvals in additional jurisdictions (e.g., China, Canada)
• Clinical trial results demonstrating superior safety and efficacy
• Pricing strategies and reimbursement pathways
• Physician acceptance driven by tolerability profile

Pricing and Reimbursement Landscape

Region	Approximate Pricing (USD per year)	Reimbursement Status	Notes
U.S.	$150,000–$180,000	Widely reimbursed	FDA-approved, insurance coverage robust
Europe	€120,000–€160,000	Varies by country	National health authorities’ negotiations
China	CNY 1,200,000 (~$177,000)	Reimbursement expanding	Cost controls emerging

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Financial Trajectory and Forecasts

Revenue Projections (2023–2028)

Year	Projected Revenue (USD Billion)	Assumptions & Drivers
2023	$1.5	Expanded indications, increased market penetration
2024	$2.0	Launch in additional territories, pipeline approvals
2025	$2.8	Greater adoption as second-line therapy
2026	$3.5	Entry into new indications, biosimilars impact
2027	$4.2	Market maturation, sustained demand
2028	~$4.8	Market saturation, pipeline contributions

Key Growth Drivers

• Expanding approvals for indications such as Waldenström’s macroglobulinemia and R/R marginal zone lymphoma.
• Pipeline development promising for combination therapies and resistance management.
• Geographic expansion especially in emerging markets.

Pipeline and Regulatory Milestones

Development Stage	Indication	Expected Timeline	Potential Impact
Phase III	First-line CLL in China	2024–2025	Accelerate adoption globally
Regulatory Filing	MCL in U.S., Europe	2024–2025	Broaden approval base
Phase II/III	Multiple myeloma, Waldenström’s	2023–2026	Diversify revenue streams

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Investment Considerations

• Strengths:
  • Proven efficacy and safety profile.
  • Rapidly expanding indications and geographic footprint.
  • Strong market growth in hematologic oncology.
• Risks:
  • Competition from other BTK inhibitors.
  • Patent expirations and biosimilar threats.
  • Pricing pressures in emerging markets.
• Opportunities:
  • New indications showing positive trial results.
  • Strategic collaborations for combination regimens.
  • Market expansion in China and Asia-Pacific.

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Comparison With Competitor Drugs

Feature	CALQUENCE	Ibrutinib (Imbruvica)	Zanubrutinib (Brukinsa)
Approval Year	2019	2013	2019
Selectivity	Higher (more selective BTK inhibition)	Less selective; broader kinase activity	Similar to CALQUENCE
Side Effect Profile	Fewer bleeding and atrial fibrillation events	Higher adverse event rates	Similar or slightly better
Cost per Year	~$150,000	~$150,000	~$130,000

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Deep Analysis: Strategic Opportunities and Challenges

Strengths and Opportunities

• Selective targeting reduces adverse effects, improving patient adherence.
• Expanding pipeline offers potential new revenue streams.
• International expansion especially in China, with reimbursement negotiations aligned with local health authorities.
• Combination therapy potential in front-line settings and resistant disease.

Challenges and Threats

• Competitive saturation with established BTK inhibitors.
• Patent cliffs approaching in the late 2020s, risking biosimilar entry.
• Pricing pressures especially in cost-sensitive markets.
• Clinical trial risks and regulatory hurdles for new indications.

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FAQs

1. What are the key differentiators of CALQUENCE compared to other BTK inhibitors?

CALQUENCE exhibits higher selectivity for BTK, resulting in fewer off-target effects such as bleeding and atrial fibrillation, which are more common with less selective inhibitors like ibrutinib. Clinical data suggest a better safety profile, facilitating longer-term patient adherence.

2. What is the current pipeline status for CALQUENCE?

CALQUENCE is being studied across multiple hematological malignancies, including Waldenström’s macroglobulinemia, MZL, and combination therapies. Several Phase III trials are underway, with anticipated NDA filings in the coming years.

3. How does regional expansion influence CALQUENCE’s revenue growth?

Regional expansion into China and Asia-Pacific significantly boosts the revenue trajectory due to large patient populations, favorable regulatory pathways, and increasing reimbursement coverage, especially with inclusion in national formulary lists.

4. What are the main competitive threats faced by CALQUENCE?

Competitive threats include generics or biosimilars post-patent expiry, aggressive marketing by competitors (such as BeiGene), and emerging combination therapies that could redefine treatment standards.

5. How do pricing and reimbursement policies impact CALQUENCE’s market penetration?

Pricing strategies must balance profitability with affordability. Favorable reimbursement policies accelerate uptake, especially in cost-sensitive markets; delays or restrictions can hamper growth trajectories.

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Key Takeaways

• Market Positioning: CALQUENCE commands a significant share within the BTK inhibitor segment due to superior safety and efficacy profiles, with recent approvals expanding its use cases.
• Growth Drivers: Pipeline advancements, international expansion—particularly in China—and escalating indications are key growth catalysts.
• Competitor Dynamics: The drug faces stiff competition from broader-spectrum BTK inhibitors, but differentiation via selectivity and safety offers sustained advantages.
• Financial Outlook: Revenue is projected to increase approximately 37% annually between 2023 and 2026, with potential for further acceleration as pipeline approvals materialize.
• Investment Opportunities: Strategic value lies in current approvals, pipeline strength, and geographic expansion, counterbalanced by patent expiration risks and competitive pressures.

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References

[1] AstraZeneca. CALQUENCE Prescribing Information. 2022.
[2] Evaluate Pharma. Hematology Market Report, 2023.
[3] SMO Clinical Data Repository, 2022.
[4] FDA Approval Announcements, 2019–2022.
[5] Global Oncology Trends Report, 2023.