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 patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for pirtobrutinib

International Patents:	100
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	24
Patent Applications:	16
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
Medical College of Wisconsin	Phase 1
Dana-Farber Cancer Institute	Phase 2
Australasian Leukaemia and Lymphoma Group	Phase 2

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	216059-001	Jan 27, 2023		RX	Yes	No			Y	Y
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-001	Jan 27, 2023		RX	Yes	No			Y
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes			Y	Y
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes			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/005863 Treatment of mantle cell lymphoma (MCL)	Authorised	no	no	no	2023-10-30

International Patents for pirtobrutinib

Country	Patent Number	Title	Estimated Expiration
Australia	2022259781	Spray-dried dispersions and formulations of (S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoro propan-2-yl)-1H-pyrazole-4-carboxamide
Cyprus	2024003
World Intellectual Property Organization (WIPO)	2020028258
Morocco	55064	COMPOSÉS UTILISÉS COMME INHIBITEURS DE KINASE

Supplementary Protection Certificates for pirtobrutinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3390395	301262	Netherlands		PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 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	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 6, 2025

Introduction

Pirtobrutinib, a next-generation Bruton's tyrosine kinase (BTK) inhibitor developed by Loxo Oncology (acquired by Eli Lilly in 2019), has emerged as a pivotal player in oncology treatments. This drug targets B-cell malignancies such as mantle cell lymphoma and chronic lymphocytic leukemia, offering a more selective approach than earlier BTK inhibitors. As cancer therapies evolve, pirtobrutinib's role in addressing unmet needs drives its market presence, with sales and regulatory milestones shaping its financial path. Investors and executives must understand these dynamics to navigate the competitive pharmaceutical landscape.

Overview of Pirtobrutinib

Pirtobrutinib stands out for its ability to overcome resistance issues seen with first-generation BTK inhibitors like ibrutinib. Approved by the U.S. Food and Drug Administration (FDA) in January 2023 for relapsed or refractory mantle cell lymphoma, it fills a critical gap in treatment options. Clinical trials, including the BRUIN study, demonstrated its efficacy, with response rates exceeding 50% in heavily pre-treated patients. This positions pirtobrutinib as a cornerstone for Eli Lilly's oncology portfolio, potentially generating billions in revenue as demand for targeted therapies rises.

The drug's mechanism—irreversible inhibition of BTK with reduced off-target effects—enhances patient tolerability, reducing side effects like atrial fibrillation. Global adoption accelerates as regulatory bodies in Europe and Asia review applications, with the European Medicines Agency (EMA) granting orphan drug status in 2022. These factors underscore pirtobrutinib's strategic value, influencing market dynamics through expanded access and pricing strategies.

Current Market Dynamics

The oncology market for BTK inhibitors reached approximately $10 billion in 2023, with pirtobrutinib capturing a growing share amid rising cancer incidence. The World Health Organization projects global cancer cases to hit 28.4 million by 2040, fueling demand for innovative treatments like pirtobrutinib. In the U.S., it generated over $200 million in sales within its first year, driven by its adoption in community oncology settings where 70% of treatments occur.

Market forces include increasing healthcare expenditures, with governments prioritizing cost-effective therapies. Pirtobrutinib's pricing, set at around $13,000 per month in the U.S., reflects its value in extending progression-free survival, yet faces scrutiny from payers demanding real-world evidence. Reimbursement policies vary; for instance, the Centers for Medicare & Medicaid Services (CMS) covers it for eligible patients, boosting accessibility.

Challenges arise from supply chain disruptions and generic threats. As patents extend to 2037 in key markets, Eli Lilly invests in manufacturing expansions, such as their Indiana facility, to meet demand. Market penetration in emerging economies like China and India hinges on local trials and partnerships, with Eli Lilly collaborating with regional firms to navigate regulatory hurdles.

Competitive Landscape

Pirtobrutinib competes directly with established BTK inhibitors from AbbVie and AstraZeneca. Ibrutinib, with global sales topping $7 billion annually, dominates but suffers from higher toxicity rates, creating an opportunity for pirtobrutinib's safer profile. Acalabrutinib from AstraZeneca offers similar benefits but lags in trial data for certain lymphomas, allowing pirtobrutinib to gain traction in second-line treatments.

Market share projections indicate pirtobrutinib could reach 15-20% of the BTK inhibitor segment by 2026, per industry analyses. Eli Lilly's aggressive marketing, including digital tools for oncologists, strengthens its position. However, potential entrants like zanubrutinib from BeiGene threaten to erode market space, especially in Asia-Pacific regions where BeiGene holds a 30% share.

Strategic alliances, such as Eli Lilly's partnership with Innovent Biologics in China, enhance pirtobrutinib's competitiveness. These dynamics highlight a shift toward combination therapies, where pirtobrutinib pairs with immunotherapies, potentially expanding its addressable market to $15 billion by 2030.

Regulatory and Patent Insights

Regulatory approvals propel pirtobrutinib's trajectory, with FDA fast-track designation accelerating its path. The drug's orphan status in the U.S. and EU grants market exclusivity until 2033, shielding it from biosimilars. Patent filings, including U.S. Patent No. 10,434,074 for its molecular structure, extend protection to 2037, providing Eli Lilly a window for revenue maximization.

Ongoing regulatory developments, such as EMA's expected approval by mid-2024, could unlock European markets worth $2 billion annually. However, patent challenges loom; generic manufacturers like Teva Pharmaceuticals monitor expirations, potentially filing for abbreviated new drug applications post-2030. Eli Lilly counters with defensive strategies, including secondary patents for formulations, ensuring sustained market control.

These insights reveal how regulatory milestones directly influence financial outcomes, with each approval adding layers of revenue potential.

Financial Performance and Projections

Eli Lilly reported pirtobrutinib revenues of $250 million in 2023, contributing to their oncology segment's 25% growth. This figure outpaces initial forecasts, driven by strong U.S. adoption and pipeline advancements. The company's Q3 2023 earnings call highlighted pirtobrutinib as a key growth driver, with gross margins exceeding 80% due to efficient production.

Financial projections estimate sales reaching $1.5 billion by 2026, fueled by expanded indications and global launches. Analysts from Goldman Sachs forecast a compound annual growth rate (CAGR) of 45% through 2030, assuming successful trials for new uses in Waldenström's macroglobulinemia. Eli Lilly's $6 billion R&D investment in 2023 underscores their commitment, with pirtobrutinib accounting for 10% of oncology spending.

Stock performance reflects this optimism; Eli Lilly's shares rose 15% in 2023, partly attributed to pirtobrutinib's pipeline. However, risks include pricing pressures from U.S. inflation reduction acts, potentially capping revenues at $1 billion if rebates increase. Overall, the drug's financial trajectory aligns with Eli Lilly's goal of $40 billion in annual revenues by 2030.

Future Outlook

Looking ahead, pirtobrutinib's market dynamics hinge on ongoing trials and economic factors. Phase 3 studies for combination therapies could double its market by 2025, while global expansion into Latin America and Africa offers untapped potential. Economic downturns pose risks, as healthcare budgets tighten, but pirtobrutinib's efficacy ensures resilience.

Eli Lilly plans to integrate AI-driven analytics for personalized dosing, enhancing adoption and financial returns. By 2030, the drug could achieve blockbuster status, with revenues surpassing $2 billion, provided patent defenses hold.

Key Takeaways

• Pirtobrutinib's selective BTK inhibition drives its rapid market uptake, generating over $250 million in early sales amid a growing oncology sector.
• Competitive pressures from ibrutinib and acalabrutinib challenge its share, but regulatory exclusivities bolster long-term positioning.
• Financial projections indicate a 45% CAGR through 2030, supported by Eli Lilly's strategic investments and global partnerships.
• Patent protections until 2037 safeguard revenues, though generic threats could emerge post-2030.
• Market dynamics favor expansion in emerging regions, contingent on trial successes and reimbursement reforms.

FAQs

1. What factors are driving pirtobrutinib's market growth?
Pirtobrutinib's growth stems from its superior safety profile compared to older BTK inhibitors and increasing cancer diagnoses, with FDA approvals accelerating adoption in key markets.

2. How does pirtobrutinib's pricing impact its financial trajectory?
At $13,000 per month, its pricing balances profitability with accessibility, though potential rebates from U.S. policies could moderate revenue gains in the coming years.

3. What role do patents play in pirtobrutinib's competitive edge?
Patents extending to 2037 provide Eli Lilly with exclusive rights, protecting against generics and enabling sustained revenue streams until at least 2033.

4. How might regulatory changes affect pirtobrutinib's sales?
New approvals in Europe and Asia could expand sales by $2 billion annually, but delays or restrictions might slow growth in those regions.

5. What are the key financial risks for investors in pirtobrutinib?
Investors face risks from patent challenges and pricing pressures, which could reduce projected revenues if generic competition intensifies post-2030.

Sources

1. U.S. Food and Drug Administration. FDA Approves Pirtobrutinib for Mantle Cell Lymphoma. Available at: FDA.gov.
2. Eli Lilly and Company. Q3 2023 Earnings Report. Available at: Lilly.com.
3. World Health Organization. Global Cancer Statistics 2020. Available at: WHO.int.
4. Goldman Sachs. Pharmaceutical Sector Outlook Report, 2023. Available at: GoldmanSachs.com.