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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 eighty-three patent family members in forty-nine 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 seven 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:	183
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	44
Patent Applications:	439
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 thirty-four 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	9,290,504		Y	Y
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	10,239,883
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	9,796,721		Y	Y
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes	9,758,524

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/005299 Calquence 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

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
Austria	525377
Hungary	S2100012
Slovenia	3689878
Denmark	3317281
Japan	6617130
Dominican Republic	P2014000008	4-IMIDAZOPIRIDAZINA-1-IL-BENZAMIDAS Y 4-IMIDAZOTRIAZINA-1-IL-BENZAMIDAS COMO INHIBIDORES DE BTK

Supplementary Protection Certificates for CALQUENCE

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
2734522	C20210006 00368	Estonia		PRODUCT NAME: AKALABRUTINIIB;REG NO/DATE: EU/1/20/1479 06.11.2020
2734522	122021000020	Germany		PRODUCT NAME: ACALABRUTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1479 20201105
2734522	301097	Netherlands		PRODUCT NAME: ACALABRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/20/1479 20201106

CALQUENCE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CALQUENCE

Introduction to CALQUENCE

CALQUENCE, also known as acalabrutinib, is a targeted therapy approved by the US FDA for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)[2].

Market Adoption and Competition

The hematology-oncology market has seen significant shifts with the introduction of new therapeutic drugs. CALQUENCE, approved in recent years, has quickly gained traction. Here are some key points regarding its market adoption:

• Growth and Market Share: By 2023, CALQUENCE has become a prominent player in the market. While IMBRUVICA saw a decline in patient counts by 51% from its peak in 2019, CALQUENCE demonstrated remarkable growth. Another drug, BRUKINSA, also showed a 149% growth from 2022 to 2023, but CALQUENCE emerged as the leading therapeutic among the five drugs analyzed, capturing 42% of the market basket share[1].
• Clinical Preferences: The rapid ascent of CALQUENCE and the decline of IMBRUVICA illustrate the competitive nature of the market and potentially shifting clinical preferences. This shift is driven by the efficacy and safety profile of CALQUENCE, as evidenced by its Breakthrough Therapy Designation and approval under the FDA’s Real Time Oncology Review (RTOR) and Project Orbis programs[2].

Payers and Demographics

Understanding the payer landscape and demographic trends is crucial for market analysis:

• Dominant Payer: Medicare was found to be the dominant payer across most prescriptions for these hematologic oncology drugs, including CALQUENCE[1].
• Demographic Variations: Non-Hispanic Whites made up the largest percentage of the treated population, at 76%, and treated patients were more likely to be male, at 61%. These findings align with existing literature on the higher incidence rates of blood cancers among White patients and male patients[1].

Financial Performance and Revenue

CALQUENCE has contributed significantly to the financial performance of its manufacturer, AstraZeneca:

• Revenue Growth: AstraZeneca reported strong revenue growth in 2022, with total revenue increasing by 25% to $44,351 million. The oncology segment, which includes CALQUENCE, saw a strong performance across key medicines and regions[3].
• Market Forecast: The market forecast for CALQUENCE indicates continued growth. The drug is expected to play a significant role in the treatment of Diffuse Large B-cell lymphoma (DLBCL) in the seven major markets (US, EU4, UK, and Japan) through 2032. The market size for CALQUENCE in DLBCL is projected to expand due to extensive research and incremental healthcare spending[4].

Affordability and Access Programs

To enhance patient access, AstraZeneca has implemented several affordability programs:

• Co-pay Savings Program: The CALQUENCE Co-pay Savings Program helps eligible patients pay a set amount of out-of-pocket costs, potentially as low as $0 per month. This program does not cover costs for office visits or other associated costs but helps make the drug more affordable[5].

Regulatory Milestones and Developmental Activities

CALQUENCE has achieved several regulatory milestones that have contributed to its market success:

• Breakthrough Therapy Designation: CALQUENCE was granted Breakthrough Therapy Designation by the FDA for its treatment of CLL, which expedited its approval process[2].
• Clinical Trials: The drug has been evaluated in several clinical trials, including the pivotal Phase III ASCEND trial, which demonstrated its efficacy in patients with relapsed or refractory CLL[2].

Safety and Efficacy Profile

The safety and efficacy profile of CALQUENCE is a critical factor in its market dynamics:

• Adverse Reactions: While CALQUENCE has shown significant efficacy, it also comes with potential adverse reactions such as hemorrhage, second primary malignancies, and infections. Monitoring patients for these risks is essential[2].
• Dosage and Administration: The drug's dosage and administration guidelines are designed to manage these risks effectively, including recommendations for prophylaxis and regular monitoring of complete blood counts[2].

Competitive Landscape

The competitive landscape for CALQUENCE includes both existing and emerging therapies:

• Market Competition: Other emerging products for DLBCL are expected to provide significant market competition to CALQUENCE. However, its strong performance and regulatory approvals position it favorably in the market[4].
• Novel Approaches: Companies are developing therapies with novel approaches to treat DLBCL, which could influence CALQUENCE's market dominance in the future[4].

Future Market Assessments

The future market assessments for CALQUENCE are positive, driven by several factors:

• Incremental Healthcare Spending: The market for DLBCL is expected to expand due to extensive research and incremental healthcare spending across the world[4].
• SWOT Analysis: A detailed SWOT analysis and market forecast indicate that CALQUENCE will continue to be a significant player in the oncology market through 2032[4].

Key Takeaways

• CALQUENCE has rapidly gained market share in the hematology-oncology sector.
• The drug's approval and strong clinical trial data have driven its adoption.
• Affordability programs enhance patient access to CALQUENCE.
• The competitive landscape includes emerging therapies, but CALQUENCE's regulatory milestones and safety profile position it strongly.
• Future market forecasts indicate continued growth and dominance in the DLBCL market.

FAQs

Q: What is CALQUENCE used for? A: CALQUENCE (acalabrutinib) is used for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)[2].

Q: How has CALQUENCE impacted the market for hematologic oncology drugs? A: CALQUENCE has significantly impacted the market by capturing 42% of the market basket share and demonstrating rapid growth, while other drugs like IMBRUVICA have seen a decline in patient counts[1].

Q: What affordability programs are available for CALQUENCE? A: The CALQUENCE Co-pay Savings Program helps eligible patients pay a set amount of out-of-pocket costs, potentially as low as $0 per month[5].

Q: What are the potential adverse reactions associated with CALQUENCE? A: Potential adverse reactions include hemorrhage, second primary malignancies, and infections. Regular monitoring is recommended to manage these risks[2].

Q: How does CALQUENCE fit into the competitive landscape of DLBCL treatments? A: CALQUENCE faces competition from emerging therapies but remains a strong player due to its regulatory approvals and clinical trial data. It is expected to continue its market dominance through 2032[4].

Cited Sources

1. Komodo Health: "Drug Snapshot: Shifting Paradigms in Hematology-Oncology"
2. NCODA: "CALQUENCE® (acalabrutinib) Receives US FDA Approval for New Indication"
3. AstraZeneca: "Full year and Q4 2022 results"
4. ResearchAndMarkets: "CALQUENCE Emerging Drug Insight and Market Forecast – 2032"
5. MyAccess360: "Calquence Affordability for Patients - AstraZeneca Access 360"