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 six 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:	6
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	216059-002	Jan 27, 2023		RX	Yes	Yes
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	10,464,905
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes	10,695,323		Y	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
Morocco	54770	Composés utilisés comme inhibiteurs de kinase
Hungary	S2400003
South Africa	202107472	COMPOUNDS USEFUL AS KINASE INHIBITORS
Canada	3224945	DISPERSIONS SECHEES PAR PULVERISATION, FORMULATIONS ET POLYMORPHIES DE (S)-5-AMINO-3-(4-((5 FLUORO-2-METHOXYBENZAMIDO)METHYL)PHENYL)(1,1,1-TRIFLUOROPROPAN-2-YL)-1H-PYRAZOLE-4-CARBOXAMIDE (SPRAY-DRIED DISPERSIONS, FORMULATIONS, AND POLYMORPHS OF (S)-5-AMINO-3-(4-((5-FLUORO-2-METHOXYBENZAMIDO)METHYL)PHENYL)-1-(1,1,1-TRIFLUOROPROPAN-2-YL)-1H-PYRAZOLE-4-CARBOXAMIDE)
World Intellectual Property Organization (WIPO)	2017103611
South Korea	20210025089	(S)-5-아미노-3--1H-피라졸-4-카르복스아미드의 분무-건조된 분산물 및 제제

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	2024C/506	Belgium		PRODUCT NAME: PIRTOBRUTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1738 20231031
3390395	LUC00330	Luxembourg		PRODUCT NAME: PIRTOBRUTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1738 20231031
3390395	PA2024506	Lithuania		PRODUCT NAME: PIRTOBRUTINIBAS; REGISTRATION NO/DATE: EU/1/23/1738 20231030
3390395	CA 2024 00006	Denmark		PRODUCT NAME: PIRTOBRUTINIB; REG. NO/DATE: EU/1/23/1738 20231031
3390395	122024000010	Germany		PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 20231031

Market Dynamics and Financial Trajectory for Pirtobrutinib

Market Overview

Pirtobrutinib, marketed as Jaypirca by Eli Lilly, is a non-covalent Bruton's tyrosine kinase (BTK) inhibitor that has been gaining significant traction in the treatment of hematologic malignancies, particularly chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and small lymphocytic lymphoma (SLL). Here’s a detailed look at the market dynamics and financial trajectory of pirtobrutinib.

Driving Factors

The global market for pirtobrutinib is driven by several key factors:

• Increasing Incidence of Blood Malignancies: The rising incidence of CLL, MCL, and SLL, coupled with the aging population, increases the demand for effective treatments like pirtobrutinib[1].
• Advances in Cancer Research: Continuous advancements in cancer research and the development of novel medicines are crucial in driving the market forward[1].
• Regulatory Approvals: Regulatory approvals and market launches of pirtobrutinib have significantly boosted its availability and acceptance[1].
• Healthcare Infrastructure: Improving healthcare infrastructure, especially in emerging nations, and rising healthcare spending support the market's growth[1].

Regional Market Performance

North America

North America dominates the pirtobrutinib market, accounting for more than 49% of the revenue. This is attributed to the high prevalence of hematologic cancers, advanced healthcare infrastructure, and substantial investments in research and development. The strong pharmaceutical presence and favorable regulatory environment in this region also contribute to the widespread adoption of pirtobrutinib[1].

Europe

In Europe, the market growth is fueled by the increasing adoption of targeted therapies and a rising incidence of CLL. Regulatory advancements and improved treatment options further drive the demand for pirtobrutinib, supported by the region’s strong healthcare systems and commitment to advancing cancer care[1].

Asia Pacific

The Asia-Pacific region is experiencing rapid growth due to rising cancer rates and improving healthcare infrastructure. Increasing awareness of targeted therapies and investments in healthcare development drive the demand for pirtobrutinib, presenting significant opportunities for expansion in emerging markets[1].

Clinical Efficacy and Safety

Recent Phase 3 results presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition have demonstrated pirtobrutinib's superior efficacy compared to other treatments. Pirtobrutinib showed a reduction in the risk of relapse, disease, or death by 46% compared to idelalisib plus rituximab or bendamustine plus rituximab. It also prolonged the time to next treatment with a median of approximately two years and showed consistent improvements in key secondary endpoints such as progression-free survival (PFS), event-free survival (EFS), and time to next treatment (TTNT)[3].

Budget Impact and Cost Considerations

Studies have shown that the budget impact of introducing pirtobrutinib into a payer’s formulary is minimal, largely due to the small patient populations eligible for treatment. From a Medicare perspective, the incremental per-member-per-month (PMPM) costs ranged from $0.011 to $0.032 over a 5-year period, while from a commercial perspective, these costs ranged from <$0.001 in years 1-3 to $0.002 in years 4-5[2].

Market Share and Competition

Pirtobrutinib is forecast to become the market leader in BTK inhibitors for CLL by 2032, capturing nearly 60% of the market share with estimated sales of about $3 billion. This dominance is expected due to its superior efficacy and safety profile compared to first-generation BTK inhibitors like Imbruvica (ibrutinib), which faces generic erosion starting in 2028. Second-generation BTK inhibitors such as AstraZeneca’s Calquence (acalabrutinib) and BeiGene’s Brukinsa (zanubrutinib) are also significant competitors but are predicted to hold smaller market shares[4].

Financial Projections

The BTK inhibitor market for CLL is valued at approximately $6 billion, with pirtobrutinib expected to generate significant revenue. By 2032, the CLL BTK inhibitor market is projected to reach nearly $5 billion in the seven major markets (US, France, Germany, Italy, Spain, UK, and Japan). Pirtobrutinib’s sales are forecasted to be around $3 billion, making it the leading BTK inhibitor in this segment[4].

Ongoing Clinical Trials and Future Indications

Pirtobrutinib is currently under investigation in 16 Phase I-III clinical trials for various indications, including first-line and subsequent-line therapies for hematological malignancies. Its potential uses include maintenance therapy after CAR-T-cell therapy, bridging therapy before CAR-T, and combination with other targeted immunotherapies. If approved for additional indications such as diffuse large B-cell lymphoma, follicular lymphoma, and marginal zone B-cell lymphoma, pirtobrutinib’s market position is expected to strengthen further[4].

Investment and Growth Opportunities

The robust financials and strong product pipeline of companies like Eli Lilly and BeiGene make them attractive investment opportunities. BeiGene, for example, is projected to generate over $2.5 billion in revenue from its BTK inhibitor Brukinsa in 2024, and its swift enrollment in clinical trials indicates a promising growth trajectory[5].

Key Takeaways

• Market Dominance: Pirtobrutinib is expected to dominate the CLL BTK inhibitor market by 2032.
• Clinical Efficacy: It has shown superior efficacy and safety in clinical trials.
• Regional Growth: North America, Europe, and the Asia-Pacific region are key markets driving growth.
• Financial Projections: Estimated sales of $3 billion by 2032.
• Ongoing Trials: Multiple clinical trials are underway to explore additional indications.
• Budget Impact: Minimal budget impact due to small patient populations.

FAQs

Q: What is pirtobrutinib used for? A: Pirtobrutinib is used for the treatment of chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and small lymphocytic lymphoma (SLL).

Q: Which region dominates the pirtobrutinib market? A: North America dominates the pirtobrutinib market with the highest revenue share.

Q: What are the key factors driving the pirtobrutinib market? A: The market is driven by the increasing incidence of blood malignancies, advances in cancer research, regulatory approvals, and improving healthcare infrastructure.

Q: How does pirtobrutinib compare to other BTK inhibitors? A: Pirtobrutinib has shown superior efficacy and safety compared to first-generation BTK inhibitors and is expected to lead the market by 2032.

Q: What are the financial projections for pirtobrutinib by 2032? A: Pirtobrutinib is forecasted to generate around $3 billion in sales by 2032, capturing nearly 60% of the CLL BTK inhibitor market share.

Sources

1. WeMarketresearch: Pirtobrutinib Market Size, Share, Global Trends & Statistics.
2. ISPOR: Budget Impact of Pirtobrutinib for Patients with Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
3. PR Newswire: Phase 3 Results for Lilly's Jaypirca (Pirtobrutinib) in Covalent BTK Inhibitor Pre-Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
4. Pharmalive: Eli Lilly's Jaypirca to Dominate CLL BTK Inhibitor Market by 2032.
5. Business Insider: BeiGene: Promising Growth Trajectory and Investment Opportunity.

Last updated: 2024-12-17