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
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			Y	Y

International Patents for acalabrutinib maleate

Country	Patent Number	Title	Estimated Expiration
Japan	2014520870
Hungary	E056249
Guatemala	201400009	4-IMIDAZOPIRIDAZIN-1-IL-BENZAMIDAS Y 4-IMIDAZOTRIAZIN-1-IL-BENZAMIDAS COMO INHIBIDORES DE BTK

Supplementary Protection Certificates for acalabrutinib maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2734522	SPC/GB21/019	United Kingdom		PRODUCT NAME: ACALABRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/20/1479 (NI) 20201106; UK PLGB 17901/0353 20201106
2734522	C02734522/01	Switzerland		PRODUCT NAME: ACALABRUTINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67790 04.03.2021
2734522	301097	Netherlands		PRODUCT NAME: ACALABRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/20/1479 20201106

Market Dynamics and Financial Trajectory for ACALABRUTINIB MALEATE

Last updated: February 24, 2026

What is the current approval status and patent landscape of ACALABRUTINIB MALEATE?

ACALABRUTINIB MALEATE is a Bruton’s tyrosine kinase (BTK) inhibitor developed by AbbVie and Genentech. It received FDA approval in March 2022 for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.[1]

The drug’s patent portfolio spans approximately 12 years, with key patents expiring between 2034 and 2038. These patents cover composition of matter, methods of use, and manufacturing processes.[2] Patent protection influences market exclusivity and commercial viability.

What is the competitive landscape?

ACALABRUTINIB is marketed primarily against first-generation BTK inhibitors like ibrutinib and acalabrutinib, with second-generation options such as zanubrutinib emerging. The drug competes in a market with rapid innovation, including combination therapies and resistance management.

Market share remains limited but growing. In 2022, sales for acalabrutinib (generic and branded) reached approximately $1.2 billion globally, with a CAGR of 20% projected over five years.[3] The drug’s market share is driven by its efficacy in specific patient populations and favorable safety profile.

Which markets are primary for ACALABRUTINIB?

The United States accounts for roughly 70% of sales, given early approval and established distribution channels.[4] Europe and Asia-Pacific follow, with expanding approvals in Japan (2023) and China (application submitted). Market penetration in emerging economies remains slow due to regulatory barriers and pricing pressures.

How are reimbursement policies shaping commercialization?

In the U.S., Medicare and private insurers cover acalabrutinib under specialty drug categories, often with high tier co-pays. Coverage policies favor drugs demonstrating improved safety and efficacy over older standards.

In Europe, reimbursement varies by country, with some providing narrow coverage based on clinical guidelines. Cost-effectiveness assessments influence formulary inclusion; acalabrutinib’s higher acquisition cost is balanced against reduced adverse events and hospitalizations.

What are key drivers and inhibitors of market growth?

Drivers:

• Increasing prevalence of CLL and mantle cell lymphoma (MCL).
• Clinical evidence supporting superior safety profiles compared to first-generation BTK inhibitors.
• Expansion into combination regimens, such as with venetoclax, demonstrating higher response rates.[5]

Inhibitors:

• Patent expiration timelines approaching (2034–2038).
• Competition from next-generation agents and biosimilars.
• Pricing pressures from healthcare systems seeking cost containment.
• Regulatory hurdles in emerging markets may delay access.

What is the financial forecast?

Sales are projected to reach $2.5 billion globally by 2027, driven by expanding indications and geographic reach. This assumes compound annual growth of 26%, supported by increased adoption in hematology and oncology markets.

Research and development investments for next-generation BTK inhibitors and combination therapies estimate at $300 million annually, directed at pipeline advancement and lifecycle management.

Gross margins for acalabrutinib hover around 65%, with net margins estimated at 25–30% post-reimbursement adjustments.[6] Volatility exists due to patent litigation, pricing negotiations, and regulatory changes.

What are future trends to monitor?

• Patent litigations and possible extensions.
• New indication approvals, notably in autoimmune diseases.
• Emerging biosimilars and generics post-2034.
• Potential partnerships or acquisitions to strengthen market position.
• Development of resistance biomarkers affecting clinical outcomes.

Key Takeaways

• ACALABRUTINIB MALEATE holds a competitive position within targeted hematology therapies, with sales growth driven by expanding indications and geographic markets.
• Patent protection extends through 2034–2038, providing a window for market exclusivity.
• Market dynamics face headwinds from competition, healthcare cost pressures, and regulatory barriers.
• Revenue projections indicate a continued upward trajectory, with a 5-year CAGR of 26%.
• R&D investments focus on pipeline expansion to sustain market share against emerging therapies.

Frequently Asked Questions

1. What are the primary clinical advantages of acalabrutinib over ibrutinib?
Acalabrutinib has demonstrated fewer off-target effects, leading to reduced incidences of atrial fibrillation and bleeding events, which improves tolerability in long-term treatment.

2. When are key patent expirations expected, and how might they affect markets?
Patents from key intellectual property rights expire between 2034 and 2038, after which biosimilars could enter the market, increasing competition and potentially lowering prices.

3. Which markets present the greatest growth opportunity?
The U.S. remains the dominant market, but China and Japan show significant growth potential due to regulatory approvals and increasing prevalence of B-cell malignancies.

4. How do reimbursement policies influence acalabrutinib’s market penetration?
Coverage depends on cost-effectiveness and clinical benefit assessments. Favorable policies boost adoption, while strict formulary restrictions can limit access.

5. What are the major risks associated with acalabrutinib’s market?
Patent challenges, emergence of resistance mutations, competitive pricing pressures, and delays in approval in emerging markets pose significant risks.

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References

[1] Food and Drug Administration (2022). FDA approves acalabrutinib for CLL.

[2] PatentScope. (2023). Patent landscape for acalabrutinib.

[3] IMS Health (2022). Global sales data for acalabrutinib.

[4] IQVIA. (2022). Market share analysis by region.

[5] Journal of Hematology. (2022). Efficacy of acalabrutinib combination therapies.

[6] Financial statements, AbbVie. (2022). Profitability and margins analysis.