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 ten patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and twenty-five patent family members in fifty-one 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 11, 2032. This may change due to patent challenges or generic licensing.

There have been nine 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:	225
US Patents:	10
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	44
Patent Applications:	2,137
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 fifty-two US patents and three 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
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes			Y	Y

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

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hungary

India

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Turkey

Ukraine

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
Australia	2016286548
Australia	2020277123
Australia	2022291635

Supplementary Protection Certificates for CALQUENCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2734522	301097	Netherlands		PRODUCT NAME: ACALABRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/20/1479 20201106
2734522	PA2021004	Lithuania		PRODUCT NAME: AKALABRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1479/001-EU/1/20/1479/002 20201105
2734522	CA 2021 00007	Denmark		PRODUCT NAME: ACALABRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1479 20201106

CALQUENCE (acalabrutinib) market dynamics and financial trajectory: exclusivity, patent estate, generic risk, and revenue outlook

Last updated: July 28, 2026

CALQUENCE (acalabrutinib) is a second-generation BTK inhibitor for B-cell malignancies. Market dynamics are shaped by (i) first-line and combination positioning against ibrutinib and venetoclax-based regimens, (ii) growing penetration in chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), and (iii) patent-protected line extensions that can delay generic and biosimilar competition. The financial trajectory tracks uptake in frontline CLL and MCL plus later-stage expansion, offset by label- and class-level competitive pressure from other BTK inhibitors (ibrutinib, zanubrutinib) and time-on-treatment dynamics.

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How much revenue does CALQUENCE (acalabrutinib) generate and what is the recent financial trajectory?

Featured-snippet answer: CALQUENCE revenue is driven primarily by U.S. and global uptake in CLL and MCL across monotherapy and combination regimens, with quarterly trend shaped by new-line approvals, subpopulation penetration, and competitive share changes within the BTK class.

Reported market performance indicators to watch

• U.S. CLL share shifts as clinicians move between BTK monotherapy, BTK plus anti-CD20, and BTK plus venetoclax-based approaches.
• MCL reimbursement and persistence tied to dose continuity and discontinuation rates in routine practice.
• Sequencing effects as patients previously exposed to other BTK inhibitors or chemoimmunotherapy enter later lines.
• Site of care and contracting effects, including formulary placement and patient access programs.

What typically drives quarter-to-quarter CALQUENCE movement

• New label uptake (new indications, new combinations, or expanded eligibility).
• Clinical adoption of “tolerability-first” BTK strategy that favors second-generation BTK inhibitors with different discontinuation profiles.
• Switching among BTK inhibitors when clinicians balance efficacy endpoints against adverse event management.
• Gross-to-net pressure from managed entry agreements, rebates, and evolving payer controls.

(Note: Specific dollar figures and a quarter-by-quarter revenue table are not included because no revenue dataset was provided in the input context.)

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What market dynamics affect CALQUENCE (acalabrutinib) in CLL and mantle cell lymphoma?

Featured-snippet answer: CALQUENCE’s market dynamics depend on BTK inhibitor class competition, the adoption curve for frontline regimens, and clinical practice migration toward regimens that reduce progression risk while maintaining tolerability.

CLL competitive map: BTK class and regimen alternatives

Key forces:

• BTK inhibitor-to-BTK inhibitor switching after intolerance or suboptimal response.
• BTK plus anti-CD20 vs BTK plus venetoclax strategy selection based on age, comorbidities, and MRD goals.
• Finite-therapy vs continuous-therapy narratives that influence patient and payer preferences.

MCL competitive map

• Second-generation BTK inhibitor differentiation on tolerability and dosing convenience.
• Combination approaches in earlier lines competing with post-progression BTK use patterns.
• Access and sequencing driven by prior exposure to BTK and prior chemoimmunotherapy.

Payer and provider behavior that can move share

• Managed care adoption where BTK class contracting creates cost-per-episode pressure.
• Formularies that prefer one BTK as “preferred” with step edits or prior authorization.

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Which drugs compete with CALQUENCE (acalabrutinib) and how does CALQUENCE compare clinically?

Featured-snippet answer: CALQUENCE competes in CLL and MCL against ibrutinib (IMBRUVICA), zanubrutinib (BRUKINSA), and other targeted regimens including venetoclax-based therapy strategies, with comparative impact driven by tolerability, dosing, and line-of-therapy fit.

BTK inhibitor comparison axes that influence uptake

• Adverse event burden and discontinuation risk (driving persistence).
• Depth of response and treatment duration implications.
• Convenience (oral dosing schedule) and monitoring intensity.
• Combination compatibility with anti-CD20 and anti-CD20 replacement strategies.

Key commercial implications

• If a competitor shows improved tolerability or a clearer finite-therapy pathway, it can pressure CALQUENCE net sales even without label overlap expansion.
• If CALQUENCE demonstrates strong frontline outcomes in real-world persistence, it can defend share against finite-therapy narratives.

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How does CALQUENCE’s patent estate affect market exclusivity and generic entry timing?

Featured-snippet answer: CALQUENCE exclusivity and the strength of its patent estate determine whether generics can enter via Paragraph IV challenges before expiration of key composition, method, or formulation patents.

What “exclusivity” typically means in CALQUENCE’s context

• Regulatory exclusivity (e.g., new chemical entity protections where applicable).
• Orphan drug exclusivity if relevant to specific indications.
• Patent coverage for:
  • Composition of matter (acalabrutinib).
  • Formulations (tablet or other dosage forms).
  • Methods of treatment (specific diseases, lines of therapy, or combinations).
  • Specific processes for manufacture.

Generic entry pathways that matter

• Paragraph IV ANDA for small-molecule tablets.
• Litigation-driven launch delays after ANDA submission if a relevant patent is listed and asserted.

(A complete timeline with patent expiration dates and Orange Book listing granularity cannot be produced from the input context.)

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What patents protect CALQUENCE (acalabrutinib), and what is the estate coverage by patent type?

Featured-snippet answer: CALQUENCE is protected by a multi-layer patent estate that typically spans composition, formulations, and method-of-use claims for CLL and MCL treatment regimens.

Estate segmentation to evaluate for litigation and entry risk

1. Composition of matter
   • Core protection for the active molecule.
2. Formulation patents
   • Tablet compositions, release characteristics, stability or manufacturing aids.
3. Method-of-use patents
   • Treatment regimens in CLL or MCL, including combination regimens.
4. Manufacturing/process patents
   • Synthesis routes and intermediate handling.

Licensing and settlement dynamics to anticipate

• Early ANDA filings usually correlate with:
  • Patent number coverage gaps.
  • Narrow method patents that are easier to design around than composition claims.
• Settlements commonly include:
  • “No-approval until” dates tied to specific patents.
  • Shared market restrictions (e.g., launch at risk vs launch after stipulated date).

(Specific CALQUENCE patent numbers are not included due to missing Orange Book and patent dataset in the input.)

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What is the Orange Book status of CALQUENCE (acalabrutinib) for generic and Paragraph IV filings?

Featured-snippet answer: Orange Book status determines whether acalabrutinib generics face a patent wall at the time of ANDA filing and whether Paragraph IV is likely to trigger litigation-based 30-month stays.

Orange Book fields that drive legal and financial outcomes

• Listed patents by:
  • Patent number and expiration date.
  • Patent type (composition, formulation, method).
• Regulatory exclusivity listed status.
• NDA and supplement mappings to which claims are tied to which label.

Financial impact of Orange Book composition

• A longer chain of unexpired patents increases the probability of delayed generic entry.
• If remaining patents are method-of-use only, entrants can attempt “carve-out” claims or design-around strategies.

(No Orange Book extract was provided; therefore listing-specific counts and dates are omitted.)

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What CALQUENCE patent litigation affects generic entry, and what settlements changed launch timelines?

Featured-snippet answer: CALQUENCE’s financial trajectory is influenced by any Paragraph IV ANDA litigation and settlement agreements that convert “at-risk” launches into delayed launches tied to patent expiration or consent schedules.

Litigation scenarios that change the revenue curve

• Early injunctions against FDA approval based on claim infringement findings.
• Consent judgments that prevent approval through a date (often the date of the last-to-expire key patent).
• Narrow win/lose outcomes where only some patents are invalidated or non-infringed.

How these events map to market dynamics

• A credible generic approval date can trigger:
  • Payer switching pressure.
  • Wholesale channel inventory shifts.
  • Downward pricing and rebate acceleration.
• Settlement timing affects competitor sequencing because the first entrant can capture the majority of post-patent share.

(Specific case captions, court dates, asserted patents, and settlement dates are omitted due to absent litigation source input.)

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When does CALQUENCE (acalabrutinib) lose exclusivity and what are the most likely generic launch windows?

Featured-snippet answer: The generic launch window depends on the last-to-expire relevant patent(s) tied to the marketed dosage form and indication, plus any regulatory exclusivity and litigation stay outcomes.

Launch window model elements

• Last-to-expire composition patent.
• Additional formulation patents that prevent non-infringing tablet substitutes.
• Method-of-use patents that can block generic label entry even if composition is expired.
• 30-month stay triggered by Paragraph IV ANDA plus any settlement “no-approval” agreements.

(A precise calendar date cannot be generated from the provided input.)

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What formulation and dosing patents for CALQUENCE could block “skinny-label” or design-around generics?

Featured-snippet answer: Formulation and dosing-related patents can block simple generic substitution even if composition is challenged, particularly when claims cover tablet structure, manufacturing process conditions, dissolution behavior, or stability specifications.

Design-around targets for generic applicants

• Alternative excipient systems that still meet bioequivalence but avoid claimed composition.
• Manufacturing process substitutions that change claim-relevant process steps.
• Dissolution profile differences that avoid specific release-characteristics claims.

Commercial consequences

• If formulation claims remain strong, first entrants can face:
  • Delay in approval or
  • Risk of delayed launch if design-around fails infringement analysis.

(Specific CALQUENCE formulation patent numbers are not included due to missing source data.)

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How does CALQUENCE’s exclusivity compare with other BTK inhibitors’ timeline and risk?

Featured-snippet answer: Competitive risk for CALQUENCE depends on whether peers face earlier generic/biosimilar-like pressure through earlier patent expirations or whether CALQUENCE has later estate “tails” tied to combinations and formulations.

Benchmarking approach for investors and licensing teams

• Compare:
  • Last-to-expire composition patents across the class.
  • Presence of long method-of-use estates in CLL and MCL.
  • Settlement and litigation histories in each molecule.
• Assess whether any peer has a more aggressive “finite-duration” narrative that can erode CALQUENCE share before patent expiry.

(No peer patent estate dataset was provided, so a quantified comparison table cannot be generated.)

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What biosimilar risk exists for CALQUENCE (acalabrutinib)?

Featured-snippet answer: No biosimilar risk exists for CALQUENCE because it is a small-molecule drug, not a biologic.

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What licensing or commercial deals surround CALQUENCE that influence market penetration and profitability?

Featured-snippet answer: Commercial deal structures for CALQUENCE generally affect net price through payer contracting and patient access, rather than licensing mechanics that directly change generic entry risk.

Profitability levers impacted by deal structure

• Net sales via rebate intensity and formulary tiering.
• Patient copay programs that reduce abandonment and support adherence.
• Managed entry agreements that shift economics based on outcomes or persistence metrics.

(Deal-specific information is not provided in the input context.)

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Key Takeaways

• CALQUENCE’s revenue trajectory is primarily a function of BTK class competition, frontline and MCL adoption, and persistence tied to tolerability and dosing.
• Generic and competition risk depends on CALQUENCE’s patent estate and Orange Book listing structure, including composition, formulation, and method-of-use coverage.
• Patent litigation and settlements, when present, convert uncertain approval dates into calendared market entry outcomes and can materially change the slope of the post-expiration revenue decline.
• Biosimilar risk is not applicable because acalabrutinib is a small molecule.

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FAQs

1) What are the main cost and net-price drivers for CALQUENCE in the U.S. market?
U.S. gross-to-net typically reflects payer rebates, formulary positioning, and managed entry arrangements tied to access and persistence.

2) Does CALQUENCE face the same generic approval risks as other BTK inhibitors?
Yes for ANDA pathway mechanics, but the magnitude depends on each molecule’s Orange Book patent tail and litigation history.

3) What impact do treatment-sequencing patterns have on CALQUENCE sales?
Sequencing determines how many eligible patients reach BTK inhibitor therapy in first-line vs later lines, affecting the size of the addressable population and switching risk.

4) How do formulation and method-of-use patents affect generic label entry versus approval timing?
Method-of-use patents can delay “label” entry even if composition is challenged, while formulation patents can delay approval if non-infringing designs are not feasible.

5) What real-world factors most influence CALQUENCE persistence and thus sales?
Discontinuation due to adverse events, dose modifications, adherence barriers, and monitoring burden drive persistence and total treated duration.

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References

(No sources were provided in the input context, and no external citations were included.)

DrugChatter Q&A for CALQUENCE

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