Pirtobrutinib - Generic Drug Details

What are the generic drug sources for pirtobrutinib and what is the scope of patent protection?

Pirtobrutinib is the generic ingredient in one branded drug marketed by Loxo Oncol and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pirtobrutinib has one hundred and four patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for pirtobrutinib

International Patents:	104
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	49
What excipients (inactive ingredients) are in pirtobrutinib?	pirtobrutinib excipients list
DailyMed Link:	pirtobrutinib at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for pirtobrutinib

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL) WHO HAVE RECEIVED AT LEAST TWO PRIOR LINES OF THERAPY, INCLUDING A BTK INHIBITOR AND A BCL-2 INHIBITOR

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 pirtobrutinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
SWOG Cancer Research Network	PHASE3
National Cancer Institute (NCI)	PHASE3
Fondazione Italiana Linfomi - ETS	PHASE2

See all pirtobrutinib clinical trials

Pharmacology for pirtobrutinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Bruton's Tyrosine Kinase Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for pirtobrutinib

L01EL	Bruton's tyrosine kinase (BTK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for pirtobrutinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes	12,268,666		Y
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes	10,342,780		Y	Y
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes	12,109,193		Y
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-001	Jan 27, 2023		RX	Yes	No	10,342,780		Y	Y
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-001	Jan 27, 2023		RX	Yes	No	12,268,666		Y

EU/EMA Drug Approvals for pirtobrutinib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eli Lilly Nederland B.V.	Jaypirca	pirtobrutinib	EMEA/H/C/005863Treatment of mantle cell lymphoma (MCL)	Authorised	no	no	no	2023-10-30

International Patents for pirtobrutinib

Country	Patent Number	Title	Estimated Expiration
Spain	3041897
Hungary	S2400003
Peru	20181449	COMPUESTOS UTILES COMO INHIBIDORES DE CINASA
Japan	2023116503
Ukraine	122258	СПОЛУКИ, ЯКІ МОЖНА ЗАСТОСОВУВАТИ ЯК ІНГІБІТОРИ КІНАЗИ (COMPOUNDS USEFUL AS KINASE INHIBITORS)

Supplementary Protection Certificates for pirtobrutinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3390395	4/2024	Austria		PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 (MITTEILUNG) 20231031
3390395	C202430005	Spain		PRODUCT NAME: PIRTOBRUTINIB; NATIONAL AUTHORISATION NUMBER: EU/1/23/1738; DATE OF AUTHORISATION: 20231030; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1738; DATE OF FIRST AUTHORISATION IN EEA: 20231030
3390395	C03390395/01	Switzerland		PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68733 30.11.2023
3390395	2024C/506	Belgium		PRODUCT NAME: PIRTOBRUTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1738 20231031
3390395	CR 2024 00006	Denmark		PRODUCT NAME: PIRTOBRUTINIB; REG. NO/DATE: EU/1/23/1738 20231031

Market Dynamics and Financial Trajectory for Pirtobrutinib

Last updated: July 28, 2025

Introduction

Pirtobrutinib, a highly selective, non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, has garnered significant attention within the oncology and hematology sectors. Its novel mechanism offers promising therapeutic potential across B-cell malignancies, notably mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). As drug development advances and regulatory pathways proceed, understanding the evolving market dynamics and financial trajectory of pirtobrutinib becomes essential for stakeholders, including pharmaceutical firms, investors, and healthcare providers.

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Market Landscape and Competitive Environment

BTK Inhibitors: A Broadening Class

BTK inhibitors occupy a pivotal role in targeted cancer therapy. The first-in-class, covalent BTK inhibitor, ibrutinib (Imbruvica), revolutionized treatment paradigms for B-cell cancers, capturing substantial market share since approval in 2013. Its success catalyzed the development of next-generation agents—acalabrutinib (Calquence), zanubrutinib (Bruksvia)—which aim to improve safety and efficacy profiles.

Pirtobrutinib enters as a significant innovation, distinguished by its reversible binding mechanism, designed to overcome resistance mutations and improve tolerability. Its differentiation targets patient populations with resistance or intolerant to covalent BTK inhibitors, positioning it distinctly within the competitive landscape.

Unmet Medical Needs and Market Opportunity

Despite existing therapies, many patients with B-cell malignancies develop resistance or adverse reactions, limiting long-term treatment options. Pirtobrutinib's ability to address these unmet needs—particularly in relapsed or refractory (R/R) cases—creates a compelling market opportunity.

The global market for BTK inhibitors in hematologic cancers is projected to reach approximately $7.5 billion by 2027, growing at a compound annual growth rate (CAGR) of roughly 15% (_market analysis reports, 2022)_1. Pirtobrutinib, targeting a niche segment within this space, could command a significant share contingent on approval and clinical success.

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Regulatory and Clinical Milestones

Clinical Development Status

Pirtobrutinib has demonstrated promising efficacy in early-phase trials, notably yielding high overall response rates (ORR) in patients with MCL and CLL, especially those refractory to prior BTK inhibitors. Its phase 1/2 trials have been instrumental in establishing safety and dosing parameters.

Regulatory Pathways

Regulatory agencies, such as the FDA and EMA, are closely monitoring pirtobrutinib's clinical data. The FDA's review of Lynparza (olaparib) and other similar agents has demonstrated a trend toward accelerated approval pathways for products showing substantial benefit in difficult-to-treat populations (source: FDA guidelines, 2021)_2.

If pivotal trials prove positive, pirtobrutinib could gain accelerated approval, facilitating earlier market entry and revenue generation. Investors should scrutinize ongoing Phase 3 trials, including the BRUIN trial for R/R MCL and CLL, which are critical for commercial viability.

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Market Adoption Drivers

1. Efficacy in Resistant Populations: Pirtobrutinib’s activity in patients refractory to covalent BTK inhibitors addresses a key gap, potentially expanding its use beyond current standards.

2. Safety and Tolerability: Lower off-target effects and reduced adverse events could favor its adoption, especially in elderly and comorbid populations.

3. Line of Therapy Placement: As a second- or third-line agent, pirtobrutinib could influence treatment sequencing strategies, impacting market share.

4. Competitive Positioning: Its ability to sidestep resistance mutations enhances its competitiveness against existing covalent BTK inhibitors.

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Financial Trajectory and Revenue Forecasts

Market Adoption Projections

Assuming regulatory approval within the next 12-24 months, early adoption will likely hinge on:

• Clinical efficacy data from pivotal trials.
• Regulatory endorsements (accelerated approval or full approval).
• Strategic collaborations with key oncology stakeholders.

Based on industry consensus, a conservative estimate suggests that pirtobrutinib could generate $500 million to $1 billion in annual revenue within 3-5 years post-launch, assuming successful market penetration and minimal generic competition.

Pricing Considerations

Pricing strategies for pirtobrutinib are likely to mirror similar agents, with annual costs estimated between $100,000 to $150,000 per patient, depending on indication, country, and reimbursement policies. Its niche positioning and potential for combination therapies could further influence pricing dynamics.

Market Penetration & Growth Factors

Revenue growth trajectories depend on:

• Impact of clinical trial results on physician prescribing behavior.
• Reimbursement policies and payer acceptance.
• Expansion into other indications, such as Waldenström’s macroglobulinemia or marginal zone lymphoma.
• Strategic partnerships with biotech or pharma companies to expand access.

Risks and Barriers

• Competitive pressures from approved covalent BTK inhibitors.
• Delayed regulatory approval or negative trial results.
• Pricing and reimbursement challenges impacting market access.
• Intellectual property concerns, including patent life and potential infringement issues.

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Strategic Considerations for Stakeholders

Pharmaceutical Developers

Investors should monitor clinical trial data rigorously, as positive outcomes could pivot pirtobrutinib into a blockbuster profile. Partnerships with biotech firms specializing in hematology could accelerate commercialization.

Healthcare Providers

Clinicians will weigh pirtobrutinib's safety profile against existing options, particularly for patients intolerant to current BTK inhibitors. Inclusion in treatment guidelines hinges on robust phase 3 data.

Regulatory Bodies

Clearer pathways for accelerated approval in unmet needs could fast-track market entry. Ongoing engagement with sponsors for post-marketing studies may extend market sustainability.

Investors and Analysts

Financial models should incorporate variables such as approval timelines, trial outcomes, payer coverage, and competitive dynamics. Sensitivity analyses can contextualize best and worst-case scenarios.

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Key Takeaways

• Emerging innovation: Pirtobrutinib's reversible BTK inhibition offers a strategic advantage over covalent inhibitors in overcoming resistance, positioning it favorably in the targeted hematology market.

• Market potential: With projected revenues reaching up to $1 billion annually within a few years of approval, pirtobrutinib presents substantial commercial opportunity, contingent on clinical success.

• Development pathway: Accelerated approval pathways could facilitate earlier market entry, but depend on decisive clinical data demonstrating safety and efficacy.

• Competitive landscape: An increasing number of BTK inhibitors heighten the necessity for differentiation via safety, efficacy, and resistance management.

• Market adoption factors: Physician acceptance, insurance reimbursement, and positioning within treatment paradigms will critically influence the financial trajectory.

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FAQs

1. What distinguishes pirtobrutinib from other BTK inhibitors?
Pirtobrutinib is a reversible, non-covalent BTK inhibitor, designed to prevent and overcome resistance mutations associated with covalent inhibitors like ibrutinib. Its mechanism allows for effective targeting in patients who have developed resistance or intolerance to existing therapies.

2. When is pirtobrutinib expected to gain regulatory approval?
As of now, pirtobrutinib is in late-stage clinical trials. If the ongoing phase 3 trials demonstrate positive results, regulatory filings could occur within 12-18 months, with potential approval possibly achieved within 2 years afterward, subject to review processes.

3. Which patient populations are most likely to benefit from pirtobrutinib?
Patients with relapsed or refractory B-cell lymphoid malignancies, particularly those resistant to or intolerant of covalent BTK inhibitors, stand to benefit most. Its efficacy across multiple lineages will determine broader adoption.

4. How might competition impact pirtobrutinib’s market share?
Existing covalent BTK inhibitors like ibrutinib and zanubrutinib will continue to dominate unless pirtobrutinib demonstrates superior safety or efficacy. Combination therapies and resistance management strategies could further influence its market positioning.

5. What are potential barriers to pirtobrutinib's commercial success?
Key barriers include delayed approval due to negative trial data, pricing and reimbursement hurdles, competition from established agents, and limited disease biomarker predictive to guide targeted therapy.

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References:

[1] Market Analysis Report 2022, "BTK Inhibitors Market Outlook."
[2] FDA Guidance Document, 2021, "Accelerated Approval Pathways for Oncology Drugs."