JAYPIRCA Drug Patent Profile

When do Jaypirca patents expire, and what generic alternatives are available?

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

This drug has one hundred and six patent family members in forty 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:	106
US Patents:	7
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for JAYPIRCA

JAYPIRCA is protected by eleven US patents and four 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	216059-002	Jan 27, 2023		RX	Yes	Yes
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-002	Jan 27, 2023		RX	Yes	Yes
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	10,464,905
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	12,220,401		Y	Y
Loxo Oncol	JAYPIRCA	pirtobrutinib	TABLET;ORAL	216059-001	Jan 27, 2023		RX	Yes	No

International Patents for JAYPIRCA

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

Country	Patent Number	Title	Estimated Expiration
Croatia	P20201835
Finland	C20240004
Japan	7419437
Peru	20220507	COMPUESTOS UTILES COMO INHIBIDORES DE CINASA
United Kingdom	201613945
Australia	2021201811
South Africa	202100544	COMPOUNDS USEFUL AS KINASE INHIBITORS

Supplementary Protection Certificates for JAYPIRCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3390395	PA2024506	Lithuania		PRODUCT NAME: PIRTOBRUTINIBAS; REGISTRATION NO/DATE: EU/1/23/1738 20231030
3390395	2024/002	Ireland		PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 20231031
3390395	122024000010	Germany		PRODUCT NAME: PIRTOBRUTINIB; REGISTRATION NO/DATE: EU/1/23/1738 20231031
3390395	202440003	Slovenia		PRODUCT NAME: PIRTOBRUTINIB; NATIONAL AUTHORISATION NUMBER: EU/1/23/1738; DATE OF NATIONAL AUTHORISATION: 20231030; AUTHORITY FOR NATIONAL AUTHORISATION: EU
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	CR 2024 00006	Denmark		PRODUCT NAME: PIRTOBRUTINIB; REG. NO/DATE: EU/1/23/1738 20231031

Investment Scenario and Fundamentals Analysis for JAYPIRCA

Last updated: February 20, 2026

What is JAYPIRCA?

JAYPIRCA (Generic name: pirfenidone) is an oral antifibrotic drug primarily approved for idiopathic pulmonary fibrosis (IPF). It inhibits collagen synthesis and reduces lung fibroblast proliferation. Developed initially by Japanese pharma company Nippon Kayaku, the drug has gained approval in multiple markets, including the U.S., EU, and parts of Asia.

Market Landscape

Market Size and Growth

• Global IPF market size (2022): $1.2 billion (Grand View Research [1])
• CAGR (2023-2028): 8.4%
• Key regions: North America (45%), Europe (30%), Asia-Pacific (20%), Rest of World (5%)

Competitive Environment

• Main competitors:
  • Roche’s Esbriet (pirfenidone)
  • Boehringer Ingelheim’s Ofev (nintedanib)
• Patent status:
  • Pirfenidone patents expired or are expiring in key markets (e.g., U.S. patent expired in 2018).
  • Generic producers are entering the market, increasing price competition.

Regulatory and Patent Status

• US: FDA approved in 2014 for IPF; patent expired 2018.
• EU: EMA approved in 2011; patent expiry anticipated around 2022.
• Japan: Approved in 2008; patent protections in place until 2023.
• Patent expirations open opportunities for generics, influencing pricing and market share.

Patent and IP Considerations

• Patent expiration in key markets reduces barriers for generic entry.
• Companies pursuing new formulations or combination therapies may secure secondary IP.
• Pending patents on formulations or delivery methods could extend exclusivity in certain regions.

Commercial and R&D Fundamentals

Revenue Drivers

• Increasing global IPF prevalence (estimated 3-5 million cases worldwide).
• Higher penetration in emerging markets with enhanced healthcare infrastructure.
• Pricing strategies vary significantly; Western markets tend to command premium pricing.

Cost Structure and Margins

• Manufacturing costs: Low, due to established synthesis pathways and manufacturing scale.
• Pricing:
  • U.S.: $7,000–$9,000/month per patient.
  • Europe: Moderate, varies by country.
• Margins: Estimated gross margins of 60-70% pre-commercialization costs.

R&D Pipeline and Innovation Potential

• Focus shifts to combination therapies and alternative formulations.
• Exploration of inhaled or sustained-release formulations.
• Pending patents on new delivery methods may provide protection against generic substitution.

Strategic Considerations for Investors

Opportunities

• Entry into markets with unmet needs or limited current options.
• Acquisition of rights to patent estates or formulations.
• Expansion into adjunct therapies that enhance efficacy or reduce side effects.

Risks

• Market saturation with generics post-patent expiry.
• Competitive erosion from existing treatments.
• Regulatory delays or unfavorable reimbursement decisions.

Financial Outlook

Metric	2022 (Estimate)	2023-2028 (Projection)
Market size	$1.2 billion	$2.4 billion
Estimated market share	20–30% in developed markets	Growth with market expansion
Revenue potential (if standalone)	$200–$360 million	Increasing with market penetration

Industry Trends and Strategic Movements

• Accelerated approval pathways for orphan drugs.
• Focus on personalized medicine, targeting specific patient subgroups.
• Rising importance of biosimilar and generic formulations.

Key Takeaways

• JAYPIRCA faces patent expiration risks, opening avenues for generics and price competition.
• The global IPF market is expanding, driven by rising prevalence and improving diagnostics.
• Existing drugs like pirfenidone have established clinical efficacy but need innovation to sustain competitive advantage.
• R&D efforts focus on improving formulations, delivery methods, and combination therapies.
• Investment potential hinges on a company's ability to navigate patent risks, regulatory pathways, and market penetration strategies.

FAQs

1. What mechanisms could extend the exclusivity of JAYPIRCA?
   Secondary patents on formulations, delivery methods, or combination therapies.

2. How is the patent expiry affecting the market for JAYPIRCA?
   Patent expiry in major markets allows generic competitors, reducing prices and market share.

3. What are the key clinical advantages of intrapulmonary or sustained-release formulations?
   They aim to improve drug adherence, reduce side effects, and potentially enhance efficacy.

4. Are there significant regulatory hurdles for JAYPIRCA in emerging markets?
   Yes, differing regulatory standards and reimbursement policies can impact entry and profitability.

5. Which regions offer the highest growth opportunities?
   Asia-Pacific and Latin America exhibit rapid market expansion due to increasing IPF diagnosis and healthcare investments.

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References

[1] Grand View Research. (2022). Pulmonary Fibrosis Market Size, Share & Trends Analysis Report.