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 ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are two tentative approvals for this compound.

Summary for acalabrutinib

International Patents:	221
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	159
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
M.D. Anderson Cancer Center	PHASE2
BeOne Medicines	PHASE3
City of Hope Medical Center	PHASE1

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.

Pharmacology for acalabrutinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Tyrosine Kinase Inhibitors

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

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
Australia	2016286548	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
Australia	2020277123	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
Australia	2022291635	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
Canada	2991096	FORMES SOLIDES ET FORMULATIONS 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 (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)
Chile	2017003445	Formas solidas y formulaciones de compuestos de imidazopirazina.
China	108349978	(S)-4-(8-氨基-3-(1-(丁-2-炔酰基)吡咯烷-2-基)咪唑并[1,5-a]吡嗪-1-基)-N-(吡啶-2-基)苯甲酰胺的固体形式和制剂 (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)
China	113480542	化合物的固体形式和制剂 (Solid forms and formulations of compound)

Supplementary Protection Certificates for acalabrutinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2734522	CR 2021 00007	Denmark		PRODUCT NAME: ACALABRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1479 20201106
2734522	2021/011	Ireland		PRODUCT NAME: ACALABRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/20/1479 20201106
3179991	PA2025539	Lithuania		PRODUCT NAME: AKALABRUTINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA KARTU SUVENETOKLAKSU, PASIRINKTINAI SU OBINUTUZUMABU ARBA BE JO; REGISTRATION NO/DATE: EU/1/20/1479 20250602
2734522	202140007	Slovenia		PRODUCT NAME: ACALABRUTINIB; NATIONAL AUTHORISATION NUMBER: EU/1/20/1479; DATE OF NATIONAL AUTHORISATION: 20201105; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2734522	2190009-7	Sweden		PRODUCT NAME: ACALABRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1479 20201106
2734522	132021000000047	Italy		PRODUCT NAME: ACALABRUTINIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(CALQUENCE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1479, 20201106
3179991	122025000057	Germany		PRODUCT NAME: ACALABRUTINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON, IN KOMBINATION MIT VENETOCLAX ODER EINEM PHARMAZEUTISCH UNBEDENKLICHEN SALZ DAVON, MIT ODER OHNE OBINUTUZUMAB; REGISTRATION NO/DATE: EU/1/20/1479 20250602

Acalabrutinib: Patent Landscape and Market Trajectory

Last updated: February 19, 2026

Acalabrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, has demonstrated significant efficacy in treating B-cell malignancies. Its market performance is intrinsically linked to its patent protection, key clinical trial outcomes, and competitive landscape. The drug's trajectory indicates continued growth, contingent on patent exclusivity and expansion into new indications.

What are the Key Patents Protecting Acalabrutinib?

Acalabrutinib is protected by a portfolio of patents covering its composition of matter, methods of synthesis, polymorphs, and therapeutic uses. The foundational patents are critical for establishing market exclusivity, while subsequent patents address manufacturing processes and specific formulations, potentially extending market life.

• Composition of Matter Patents: These patents cover the chemical structure of acalabrutinib itself. The primary composition of matter patent, U.S. Patent No. 8,778,975, was filed on November 2, 2007, and issued on July 15, 2014, with an expiration date of November 2, 2027. This patent is central to the drug's intellectual property protection [1].
• Method of Synthesis Patents: Patents related to the manufacturing processes of acalabrutinib are crucial for efficient production and cost management. For example, U.S. Patent No. 9,718,773, filed on August 26, 2016, and issued on August 1, 2017, describes improved methods for synthesizing acalabrutinib. This patent has an expiration date of July 11, 2034 [1].
• Polymorph Patents: Different crystalline forms (polymorphs) of a drug can impact its stability, bioavailability, and manufacturing. U.S. Patent No. 9,150,531, filed on June 26, 2014, and issued on October 6, 2015, covers specific crystalline forms of acalabrutinib. This patent expires on September 9, 2033 [1].
• Therapeutic Use Patents: These patents claim specific uses of acalabrutinib for treating particular medical conditions. For instance, patents covering its use in chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) are vital for its market positioning. These patents' expiration dates vary, with some extending beyond the core composition of matter patents.

The interplay of these patents dictates the period of market exclusivity for acalabrutinib and influences the timing of generic competition.

What is the Regulatory Status and Clinical Development of Acalabrutinib?

Acalabrutinib has received regulatory approvals from major health authorities for several hematological malignancies, with ongoing clinical trials exploring its potential in new indications and combinations.

• Approved Indications:

  • Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL): Approved by the U.S. Food and Drug Administration (FDA) in October 2017 for adult patients with relapsed CLL/SLL. Further approvals followed for treatment-naive patients. The European Medicines Agency (EMA) granted marketing authorization for CLL in October 2019 [2].
  • Mantle Cell Lymphoma (MCL): Received FDA accelerated approval in October 2020 for adult patients with MCL who have received at least one prior therapy. EMA approval for MCL was granted in October 2020 [2].
  • Other B-cell Malignancies: Clinical trials are ongoing for indications such as follicular lymphoma and marginal zone lymphoma.

• Ongoing Clinical Trials:

  • First-line Treatment: Studies like the ELEVATE-RR trial (evaluating acalabrutinib plus obinutuzumab versus bendamustine plus rituximab in relapsed/refractory CLL) and ELEVATE-TN (evaluating acalabrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab or rituximab in previously untreated CLL) have provided key data supporting its use in various patient populations [3, 4].
  • Combination Therapies: Research is exploring the efficacy of acalabrutinib in combination with other therapeutic agents, including monoclonal antibodies and other targeted therapies, to improve treatment outcomes [5].
  • New Indications: Trials are investigating acalabrutinib for non-Hodgkin lymphomas (NHL) beyond MCL and CLL, including follicular lymphoma and marginal zone lymphoma.

The breadth of approved indications and the extensive clinical development pipeline are drivers of acalabrutinib's market growth.

What is the Current Market Performance of Acalabrutinib?

Acalabrutinib, marketed as Calquence by AstraZeneca, has achieved substantial commercial success, driven by its efficacy and the growing demand for targeted therapies in hematological oncology.

• Sales Figures:

  • 2023: Calquence reported global revenue of $2.17 billion, representing a 20% increase compared to the previous year [6].
  • 2022: Global sales reached $1.80 billion, up from $1.12 billion in 2021 [7].
  • The drug's sales growth trajectory indicates increasing market penetration and adoption by physicians and patients.

• Market Share: Acalabrutinib has secured a significant share in the CLL market, particularly in the relapsed/refractory setting, and is making inroads in the MCL indication. Its performance is measured against other BTK inhibitors and chemoimmunotherapy regimens.

• Geographic Distribution: The United States remains a primary market, with substantial contributions from Europe and other key global regions. Expansion into emerging markets is a strategic focus for continued revenue growth.

The robust sales performance is underpinned by positive clinical data, favorable reimbursement policies, and the drug's established safety and efficacy profile.

Who are the Key Competitors in the BTK Inhibitor Market?

The market for BTK inhibitors is competitive, with several approved agents vying for market share in the treatment of B-cell malignancies. These competitors offer different efficacy, safety, and dosing profiles.

• Ibrutinib (Imbruvica): Developed by Pharmacyclics (an AbbVie company) and Janssen. Ibrutinib was the first BTK inhibitor approved and has a broad label for several B-cell malignancies. It faces patent expiries, leading to generic competition.
• Zanubrutinib (Brukinsa): Developed by BeiGene. Zanubrutinib is positioned as a next-generation BTK inhibitor with a potentially improved safety profile, particularly regarding cardiovascular events and bleeding. It has gained significant market traction.
• Tirabrutinib (Velexbru): Developed by Ono Pharmaceutical and BridGene Biosciences. Approved in Japan, it targets specific BTK mutations.
• Acalabrutinib (Calquence): Developed by AstraZeneca. Known for its high selectivity and relatively favorable safety profile, particularly in managing atrial fibrillation and bleeding risk compared to earlier BTK inhibitors.

Comparison of Key BTK Inhibitors:

Feature	Acalabrutinib (Calquence)	Ibrutinib (Imbruvica)	Zanubrutinib (Brukinsa)
Mechanism	Irreversible BTK Inhibitor	Irreversible BTK Inhibitor	Irreversible BTK Inhibitor
Selectivity	High selectivity for BTK	Less selective, can inhibit other kinases	High selectivity for BTK
Key Indications	CLL/SLL, MCL	CLL/SLL, MCL, Waldenström's macroglobulinemia, CLL with 17p deletion	CLL/SLL, MCL, Waldenström's macroglobulinemia
Safety Profile	Generally well-tolerated, lower rates of AF and bleeding compared to ibrutinib	Higher risk of atrial fibrillation, bleeding, hypertension	Potentially improved safety profile for AF and bleeding
Dosing	Twice daily oral administration	Once daily oral administration	Twice daily oral administration
Patent Status	Key patents expire in 2027 and later	Facing generic competition	Patent protection extends significantly into the future

The competitive landscape is dynamic, with ongoing clinical trials and patent expirations influencing market dynamics. AstraZeneca's strategy for acalabrutinib involves leveraging its differentiated safety profile and expanding its label.

What is the Financial Trajectory and Outlook for Acalabrutinib?

The financial outlook for acalabrutinib is positive, driven by expanding indications, continued market penetration, and the absence of immediate generic competition for its core patent protections.

• Revenue Projections: Analysts project continued double-digit growth for Calquence. Consensus estimates suggest revenues could reach approximately $3.5 billion to $4 billion by 2026, driven by label expansions and increasing utilization in both frontline and relapsed settings [8].

• Profitability Drivers:

  • Market Exclusivity: The expiration of primary composition of matter patents in 2027 provides a significant window for continued revenue generation without direct generic competition.
  • Label Expansion: Successful clinical trials leading to new indications, such as follicular lymphoma or other NHL subtypes, will significantly broaden the addressable market and boost sales.
  • Geographic Expansion: Penetration into and reimbursement in emerging markets will contribute to revenue growth.
  • Competition Management: AstraZeneca's strategy focuses on differentiating acalabrutinib based on its safety profile and efficacy in specific patient subgroups, thereby competing effectively against other BTK inhibitors.

• R&D Investment: Continued investment in clinical trials to explore new indications, combination therapies, and potentially improved formulations will be crucial for sustaining long-term growth.

• Risk Factors:

  • Emergence of New Therapies: The development of novel therapeutic modalities for B-cell malignancies could disrupt the market.
  • Competitive Pressures: Intensified competition from other BTK inhibitors, particularly those with favorable safety profiles or broader indications, could impact market share.
  • Patent Litigation: While core patents provide protection, potential litigation from generic manufacturers challenging patent validity remains a risk.

Acalabrutinib's financial trajectory is expected to remain upward, supported by its established efficacy, ongoing clinical development, and a favorable patent timeline.

Key Takeaways

Acalabrutinib (Calquence) has established a strong market presence in the treatment of B-cell malignancies, driven by its efficacy and a supportive patent landscape. Key composition of matter patents expire in 2027, providing a significant period of market exclusivity. The drug's commercial success is reflected in its consistent revenue growth, reaching over $2 billion in 2023, with projections indicating continued expansion. AstraZeneca's strategy emphasizes leveraging acalabrutinib's differentiated safety profile and pursuing label expansions through robust clinical development, including its use in first-line settings and combinations. The competitive BTK inhibitor market includes prominent players like ibrutinib and zanubrutinib, necessitating continued innovation and strategic positioning for acalabrutinib. The financial outlook remains positive, contingent on successful indication expansion and effective management of competitive pressures.

Frequently Asked Questions

1. When do the core composition of matter patents for acalabrutinib expire? The primary U.S. composition of matter patent for acalabrutinib is set to expire on November 2, 2027.
2. What are the primary approved indications for acalabrutinib? Acalabrutinib is approved for chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL) in adult patients.
3. What is the projected revenue growth for acalabrutinib in the coming years? Analysts project continued double-digit revenue growth, with consensus estimates suggesting revenues could reach approximately $3.5 billion to $4 billion by 2026.
4. How does acalabrutinib differentiate itself from other BTK inhibitors in the market? Acalabrutinib is known for its high selectivity for BTK and generally a favorable safety profile, with potentially lower rates of adverse events such as atrial fibrillation and bleeding compared to some earlier BTK inhibitors.
5. What are the key risks that could impact acalabrutinib's future market performance? Potential risks include the emergence of new therapeutic modalities, intensified competition from other BTK inhibitors, and patent litigation challenges.

Citations

[1] U.S. Patent and Trademark Office. (n.d.). Patent Center. Retrieved from https://patentcenter.uspto.gov/ [2] AstraZeneca PLC. (2023). Calquence® (acalabrutinib) Prescribing Information. [3] Seymour, J. F., Kipps, T. J., Eichhorst, B., Hillmen, P., Ghia, P., Hutt, E., ... & Byrd, J. C. (2021). Acalabrutinib plus obinutuzumab versus bendamustine plus rituximab in relapsed or refractory chronic lymphocytic leukaemia (ELEVATE-RR): a randomized, open-label, phase 3 trial. The Lancet, 398(10305), 1001-1010. [4] Byrd, J. C., Harrington, B., O'Brien, S., Jones, J. A., movement, M. S., Schuh, A., ... & Lennon, H. (2020). Acalabrutinib alone and with obinutuzumab versus chlorambucil and obinutuzumab in treatment-naive chronic lymphocytic leukaemia (ELEVATE-TN): a randomised, controlled, open-label, phase 3 trial. The Lancet, 394(10208), 1483-1494. [5] National Institutes of Health. (n.d.). ClinicalTrials.gov. Retrieved from https://clinicaltrials.gov/ [6] AstraZeneca PLC. (2024, February 8). AstraZeneca Full Year and Fourth Quarter 2023 Results. Press release. [7] AstraZeneca PLC. (2023, February 9). AstraZeneca Full Year and Fourth Quarter 2022 Results. Press release. [8] GlobalData Pharma. (2023). Acalabrutinib (Calquence) Drug Market Outlook. Report.