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 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	44
Patent Applications:	2,613
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

NDA:

210259

Dosage:

CAPSULE;ORAL

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 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

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/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 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
Russian Federation	2018103913	ТВЕРДЫЕ ФОРМЫ И КОМПОЗИЦИИ (S)-4-(8-АМИНО-3-(1-(БУТ-2- ИНОИЛ)ПИРРОЛИДИН-2-ИЛ)ИМИДАЗО[1,5-A]ПИРАЗИН-1-ИЛ)-N-(ПИРИДИН-2-ИЛ)БЕНЗАМИДА
Brazil	112014001255	composto, uso de um composto, combinação, e, composição farmacêutica
Japan	7054721

Supplementary Protection Certificates for CALQUENCE

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 Calquence

Last updated: February 19, 2026

What is Calquence?

Calquence (acalabrutinib) is an oral Bruton’s tyrosine kinase (BTK) inhibitor developed by AstraZeneca. Approved by the U.S. Food and Drug Administration (FDA) in October 2019, it targets specific B-cell malignancies, primarily mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL).

Market Penetration and Growth

Approved Indications and Market Share

Indication	FDA Approval Date	Market Penetration (2023)	Key Competitors
Mantle Cell Lymphoma (MCL)	October 2019	55% of BTK inhibitor sales	ibrutinib (Imbruvica), acalabrutinib (Calquence)
Chronic Lymphocytic Leukemia (CLL)	November 2019	30% of BTK inhibitor sales	ibrutinib (Imbruvica), zanubrutinib (Brukinsa)

The drug has rapidly gained market share due to its favorable safety profile compared to older BTK inhibitors like ibrutinib, especially regarding cardiovascular side effects.

Geographical Market Expansion

• U.S. remains the primary market.
• European and Asian markets are under expansion, with regulatory approvals in multiple countries.

Patient Population and Revenue Projections

• 2023 sales estimate: $1.2 billion globally.
• Market growth rate: CAGR of 12% projected through 2028, driven by expanding indications and adoption in combination therapies.
• Key drivers: Enhanced safety profile, expanding indications, and ongoing clinical trials.

Competitive Landscape

Major Competitors

• Ibrutinib (Imbruvica): Established standard, launched 2013.
• Zanubrutinib (Brukinsa): Approved 2019; lower cardiac adverse events.
• Acalabrutinib’s advantage arises from fewer off-target effects, leading to its preferred profile in some patient segments.

Market Entry and Patent Expirations

• Ibrutinib’s patent expiration in 2027.
• Acalabrutinib’s patent protection extends through 2031.
• Competitive pressure may increase from next-generation BTK inhibitors.

R&D and Pipeline Developments

• Additional indications: Waldenström’s macroglobulinemia and chronic graft-versus-host disease are under investigation.
• Combination therapies: Trials with BCL-2 inhibitors, monoclonal antibodies, and chemotherapies aim to strengthen compound efficacy.

Regulatory and Pricing Policies

• Pricing strategies: Premium pricing with a premium for safety.
• Access policies: Negotiations with insurers in major markets.
• Regulatory landscape: Ongoing clinical trials aim to expand approvals, potentially influencing pricing models.

Financial Outlook

Year	Revenue (USD billion)	Growth Rate	Key Factors
2023	1.2	--	Market penetration, expanding indications
2024	1.35	12.5%	Broader approvals, off-label use
2025	1.52	12.7%	Patient access programs, clinical data
2026	1.70	11.8%	Competition intensifies, pipeline impact

Anticipated revenue growth remains steady due to increasing adoption, although market share may plateau as competitors strengthen their presence.

Key Challenges and Risks

• Patent expirations of leading competitors.
• Clinical trial results for combination therapies influencing market dynamics.
• Regulatory hurdles in emerging markets.
• Pricing negotiations affecting profitability.

Key Takeaways

• Calquence holds a significant position in the BTK inhibitor market, with dominant presence in MCL and CLL.
• Its growth benefits from a favorable safety profile and expanding indications.
• Competitive pressure from next-generation BTK inhibitors and patent cliffs will influence future revenue.
• Ongoing clinical trials and pipeline expansion are crucial to sustaining its market trajectory.

FAQs

1. How does Calquence differentiate from other BTK inhibitors?

It has a more selective target profile, resulting in fewer cardiac and bleeding side effects compared to ibrutinib.

2. What are the primary markets for Calquence?

The U.S. is the largest market, with European and Asian countries expanding rapidly.

3. What is the projected revenue for Calquence in the next five years?

Revenue is expected to grow from $1.2 billion in 2023 to approximately $1.70 billion by 2026, assuming steady market penetration.

4. What clinical developments could impact Calquence’s market share?

Trials exploring new indications, combination therapies, or head-to-head comparisons may alter competitive positioning.

5. How vulnerable is Calquence to generic competition?

Patent expiry in 2031 provides some protection; however, patent challenges and biosimilar developments in the future could influence market dynamics.

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References

[1] AstraZeneca. (2023). Calquence prescribing information.
[2] Market Research Future. (2022). BTK inhibitor market analysis.
[3] IQVIA. (2023). Global oncology market report.
[4] FDA. (2019). Approval of Calquence for mantle cell lymphoma.
[5] EvaluatePharma. (2023). Oncology drug forecast.