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 eighty-one patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for acalabrutinib maleate

International Patents:	181
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	10
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

Constraining patent/regulatory exclusivity:

11,059,829

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	11,771,696
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	9,758,524
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	11,059,829		Y	Y

International Patents for acalabrutinib maleate

Country	Patent Number	Title	Estimated Expiration
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
China	103889987	4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as btk-inhibitors
European Patent Office	4209493	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)

Supplementary Protection Certificates for acalabrutinib maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2734522	2021016	Norway		PRODUCT NAME: AKALABRUTINIB; REG. NO/DATE: EU/1/20/1479 20201111
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	LUC00202	Luxembourg		PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106

Acalabrutinib maleate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acalabrutinib Maleate

Introduction

Acalabrutinib, marketed as CALQUENCE, is a next-generation, selective inhibitor of Bruton's tyrosine kinase (BTK) that has been making significant strides in the treatment of various lymphomas and leukemias. This article delves into the market dynamics and financial trajectory of acalabrutinib maleate, highlighting its current status, future prospects, and the impact on the pharmaceutical market.

Mechanism of Action and Clinical Use

Acalabrutinib binds covalently to BTK, inhibiting its activity and thereby disrupting B-cell signaling pathways essential for B-cell proliferation, trafficking, chemotaxis, and adhesion. This mechanism is crucial in treating B-cell malignancies such as mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL)[1][4].

Regulatory Milestones

Acalabrutinib has received several key regulatory approvals. It was initially approved in 2017 for the treatment of adult patients with MCL who have received at least one prior therapy. In 2019, it was approved for the treatment of adult patients with CLL or SLL. Recently, the FDA granted priority review to acalabrutinib for previously untreated MCL, based on data from the Phase 3 ECHO trial[2][4].

Clinical Trials and Efficacy

The Phase 3 ECHO trial demonstrated that patients treated with acalabrutinib in combination with bendamustine and rituximab had a median progression-free survival (PFS) of 66.4 months, significantly better than the 49.6 months observed in the placebo group. The trial also showed a trend towards improved overall survival (OS) in the acalabrutinib arm[2].

Market Assessment and Forecast

The market for acalabrutinib is expected to grow significantly due to its efficacy and the increasing demand for targeted therapies in lymphoma treatments. The extensive research and development activities, including ongoing clinical trials, are set to expand the market size. For instance, the combination of acalabrutinib with other therapies, such as R-CHOP and RICE, is being evaluated in various clinical trials for different lines of therapy in diffuse large B-cell lymphoma (DLBCL)[1].

Competitive Landscape

The market for DLBCL and other B-cell malignancies is competitive, with several emerging therapies. However, acalabrutinib's strong clinical data and its position as a next-generation BTK inhibitor give it a competitive edge. The launch of late-stage emerging therapies will impact the market, but acalabrutinib's established presence and ongoing development programs are expected to maintain its market dominance[1].

Financial Performance and Revenue Growth

AstraZeneca, the developer of acalabrutinib, has seen significant revenue growth from its oncology portfolio, which includes CALQUENCE. In 2022, AstraZeneca's total revenue increased by 25%, with oncology product sales growing by 19%. The company is on track to deliver industry-leading revenue growth through 2025 and beyond, driven by the success of its oncology medicines, including CALQUENCE[3].

Revenue Projections

The forecasted sales data for CALQUENCE from 2027 to 2032 indicate a strong growth trajectory. This growth is supported by the drug's expanding indications, increased patient access, and the ongoing clinical development programs. The detailed analysis of forecasted sales will help clients in decision-making regarding their therapeutic portfolios[1].

Safety and Tolerability

Acalabrutinib has shown a manageable safety profile in clinical trials. Common adverse events include atrial fibrillation, hypertension, major bleeding, infections, and second primary malignancies. However, the overall safety data support its use as a viable treatment option for patients with B-cell malignancies[2].

Market Expansion and Geographic Reach

The market for acalabrutinib is not limited to the United States; it has a significant presence in other major markets, including Germany, France, Italy, Spain, the United Kingdom, and Japan. The drug's approval and adoption in these regions are expected to contribute to its global revenue growth[1].

Impact of COVID-19

While COVID-19 has presented challenges, including impacts on clinical trial conduct and patient care, acalabrutinib's development and market trajectory have remained robust. The FDA's priority review and the ongoing clinical trials have not been significantly hindered by the pandemic[2].

Future Prospects and Development

AstraZeneca continues to invest in the development of acalabrutinib, with several ongoing and planned clinical trials. The combination of acalabrutinib with other therapies, such as axicabtagene ciloleucel, is being evaluated as a third-line treatment for B-cell lymphoma, including relapsed/refractory DLBCL. These initiatives are expected to further expand the drug's market potential[1].

Key Takeaways

• Mechanism and Clinical Use: Acalabrutinib is a selective BTK inhibitor effective in treating B-cell malignancies.
• Regulatory Approvals: Approved for MCL, CLL, and SLL, with priority review for untreated MCL.
• Clinical Efficacy: Demonstrated significant PFS and OS benefits in clinical trials.
• Market Growth: Expected to grow due to expanding indications and strong clinical data.
• Financial Performance: Contributing to AstraZeneca's revenue growth in the oncology segment.
• Safety and Tolerability: Manageable safety profile with common adverse events.
• Geographic Reach: Significant presence in major global markets.
• Future Prospects: Ongoing and planned clinical trials to further expand its market potential.

FAQs

What is the mechanism of action of acalabrutinib?

Acalabrutinib binds covalently to Bruton's tyrosine kinase (BTK), inhibiting its activity and disrupting B-cell signaling pathways.

What are the approved indications for acalabrutinib?

Acalabrutinib is approved for the treatment of adult patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL).

What is the current status of acalabrutinib in clinical trials?

Acalabrutinib is in various stages of clinical trials, including Phase 3 trials for untreated MCL and combination therapies for DLBCL.

How does acalabrutinib compare to other BTK inhibitors?

Acalabrutinib is considered a next-generation BTK inhibitor with a strong clinical profile and fewer off-target effects compared to first-generation inhibitors.

What is the expected market growth for acalabrutinib?

The market for acalabrutinib is expected to grow significantly due to its efficacy, expanding indications, and strong clinical data.

Sources

1. CALQUENCE (Acalabrutinib) Emerging Drug Insights and Market Forecasts - ResearchAndMarkets.com
2. FDA Grants Priority Review to Acalabrutinib in Treatment-Naive Mantle Cell Lymphoma - Onclive
3. Full year and Q4 2022 results | AstraZeneca
4. CALQUENCE®, as acalabrutinib capsules, Clinical Pharmacology Review - FDA
5. Acalabrutinib maleate monohydrate | DrugBank Online