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JAYPIRCA Drug Patent Profile

Which patents cover Jaypirca, and when can generic versions of Jaypirca launch?

Jaypirca is a drug marketed by Loxo Oncol and is included in one NDA. There are five patents protecting this drug.

This drug has ninety-seven patent family members in thirty-eight countries.

The generic ingredient in JAYPIRCA is pirtobrutinib. One supplier is listed for this compound. Additional details are available on the pirtobrutinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Jaypirca

Jaypirca will be eligible for patent challenges on January 27, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 1, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for JAYPIRCA

International Patents:	97
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	1
Patent Applications:	12
Drug Prices:	Drug price information for JAYPIRCA
What excipients (inactive ingredients) are in JAYPIRCA?	JAYPIRCA excipients list
DailyMed Link:	JAYPIRCA at DailyMed

See drug prices for JAYPIRCA

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

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

NDA:

216059

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 JAYPIRCA

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

Sponsor	Phase
Medical College of Wisconsin	Phase 1

See all JAYPIRCA clinical trials

Pharmacology for JAYPIRCA

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

US Patents and Regulatory Information for JAYPIRCA

JAYPIRCA is protected by eight US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

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
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-001	Jan 27, 2023		RX	Yes	No	10,918,622
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	216059-001	Jan 27, 2023		RX	Yes	No	10,342,780		Y	Y
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes	10,918,622

EU/EMA Drug Approvals for JAYPIRCA

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 JAYPIRCA

See the table below for patents covering JAYPIRCA around the world.

Country	Patent Number	Title	Estimated Expiration
France	24C1009
South Korea	102215792
South Korea	20180115261
Chile	2018001591

Supplementary Protection Certificates for JAYPIRCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3390395	C03390395/01	Switzerland		PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68733 30.11.2023
3390395	301262	Netherlands		PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 20231031
3390395	LUC00330	Luxembourg		PRODUCT NAME: PIRTOBRUTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1738 20231031
3390395	CA 2024 00006	Denmark		PRODUCT NAME: PIRTOBRUTINIB; REG. NO/DATE: EU/1/23/1738 20231031

JAYPIRCA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Jaypirca

Introduction to Jaypirca

Jaypirca, developed by Eli Lilly, is a Bruton tyrosine kinase (BTK) inhibitor that has recently gained significant attention in the treatment of chronic lymphocytic leukemia (CLL) and other hematological malignancies. Here, we delve into the market dynamics and financial trajectory of this promising drug.

Market Leadership in BTK Inhibitors

By 2032, Jaypirca is forecasted to become the market leader in BTK inhibitors for CLL, capturing nearly 60% of the market share with estimated sales of about $3 billion. This dominance is attributed to its efficacy and the ongoing clinical trials that are expanding its potential uses[1][3][4].

Competitive Landscape

The BTK inhibitor market is highly competitive, with several key players:

• Imbruvica (Ibrutinib): Currently the market leader since 2013, Imbruvica is facing significant challenges. Its market exclusivity is set to end in the US by 2028 and in the 5EU (France, Germany, Italy, Spain, and the UK) by 2029. Additionally, it is the only cancer drug listed for price negotiations with Medicare under the Biden administration, which will require a price reduction in the US by 2026[1][3].
• Calquence (Acalabrutinib): Developed by AstraZeneca, Calquence is expected to occupy the second position in the market, with sales exceeding $1 billion and a market share of 21.7% by 2032[1][3].
• Brukinsa (Zanubrutinib): BeiGene’s Brukinsa is predicted to secure the third place with $774 million in sales, representing 15.8% of the overall BTK inhibitor therapy market share by 2032[1][3].

Clinical Trials and Expanding Indications

Jaypirca is currently involved in 16 Phase I-III clinical trials, investigating its potential as a first-line and subsequent-line therapy for various hematological malignancies. Its potential uses include maintenance therapy after CAR-T-cell therapy, bridging therapy before CAR-T, and combination with other targeted immunotherapies such as bispecific or trispecific antibodies. This expansive clinical trial landscape is crucial for its future market position[1][3][4].

FDA Approvals and Regulatory Milestones

Jaypirca received accelerated FDA approval in December 2023 for patients with CLL or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy. The drug has shown significant efficacy, with a tumor shrinkage rate of 72% in patients previously treated with both a BTK and a BCL-2 inhibitor. The confirmatory trial, BRUIN MCL-321, is ongoing, comparing Jaypirca against Imbruvica, Calquence, or Brukinsa in mantle cell lymphoma patients[4].

Financial Performance and Projections

Eli Lilly's robust financial performance, particularly in the third quarter of 2024, sets a strong foundation for Jaypirca's future success. Here are some key financial highlights:

• Revenue Growth: Eli Lilly reported a 42% revenue increase in Q3 2024, driven by its diabetes and cancer drugs, including Mounjaro and Zepbound. This growth trajectory is expected to continue, with the company raising its 2024 revenue guidance to $45.4 billion to $46 billion[2].
• Jaypirca Sales: Although Jaypirca's initial sales were modest, with $22.7 million in Q3 2023 following its limited indication approval, its market share and sales are expected to surge as it gains broader approvals and market acceptance[4].

Market Size and Growth Potential

The BTK inhibitor market for CLL is projected to reach nearly $5 billion by 2032 in the seven major markets (US, France, Germany, Italy, Spain, UK, and Japan). Jaypirca's dominance in this market, coupled with its potential expansion into other indications such as diffuse large B-cell lymphoma, follicular lymphoma, and marginal zone B-cell lymphoma, positions it for significant growth[3].

Advantages Over First-Generation BTK Inhibitors

Second-generation BTK inhibitors like Jaypirca offer several advantages over first-generation drugs like Imbruvica. These include fewer off-target effects, reduced cardiotoxicity, and the ability for patients to maintain treatment longer, thereby increasing efficacy. These advantages are driving the shift towards second-generation inhibitors in the market[3].

Conclusion

Jaypirca is poised to dominate the BTK inhibitor market for CLL by 2032, driven by its strong clinical performance, expanding indications, and favorable market dynamics. As Eli Lilly continues to invest in its pipeline and manufacturing capabilities, Jaypirca is expected to play a pivotal role in the company's financial growth and market leadership.

Key Takeaways

• Market Leadership: Jaypirca is forecasted to capture nearly 60% of the BTK inhibitor market for CLL by 2032.
• Clinical Trials: Ongoing clinical trials are expanding Jaypirca's potential uses, including maintenance and bridging therapies.
• FDA Approvals: Accelerated FDA approval and ongoing confirmatory trials are crucial for its market position.
• Financial Projections: Jaypirca's sales are expected to surge as it gains broader market acceptance.
• Market Size: The BTK inhibitor market for CLL is projected to reach nearly $5 billion by 2032.
• Advantages: Second-generation BTK inhibitors like Jaypirca offer fewer off-target effects and reduced cardiotoxicity.

FAQs

Q: What is Jaypirca and how does it work? A: Jaypirca (pirtobrutinib) is an oral BTK inhibitor designed to treat CLL and other hematological malignancies by causing cancerous B-lymphocytes to leave the bone marrow and lymph nodes and enter the bloodstream, where they can be more easily targeted and eliminated[5].

Q: What is the current market position of Jaypirca? A: Jaypirca is expected 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[1][3].

Q: How does Jaypirca compare to other BTK inhibitors? A: Jaypirca offers fewer off-target effects and reduced cardiotoxicity compared to first-generation BTK inhibitors like Imbruvica, making it a preferred option for long-term treatment[3].

Q: What are the ongoing clinical trials for Jaypirca? A: Jaypirca is involved in 16 Phase I-III clinical trials, exploring its potential as a first-line and subsequent-line therapy for various hematological malignancies, including maintenance and bridging therapies[1][3].

Q: What are the financial projections for Eli Lilly with Jaypirca? A: Eli Lilly has raised its 2024 revenue guidance to $45.4 billion to $46 billion, with Jaypirca expected to contribute significantly to this growth as it gains broader market acceptance and approvals[2].

Sources

1. Eli Lilly's Jaypirca to dominate CLL BTK inhibitor market by 2032 - Biopharma Reporter
2. Earnings call: Eli Lilly reports robust Q3 growth, raises 2024 guidance - Investing.com
3. Eli Lilly's Jaypirca to dominate CLL BTK inhibitor market by 2032, says GlobalData - GlobalData
4. Lilly's Jaypirca blazes leukemia trail with FDA nod, fast confirmatory trial filing - FiercePharma
5. Pirtobrutinib (Jaypirca®) for Chronic Lymphocytic Leukemia (CLL) - ChemoExperts