KLISYRI Drug Patent Profile

When do Klisyri patents expire, and when can generic versions of Klisyri launch?

Klisyri is a drug marketed by Almirall and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventeen patent family members in twenty-six countries.

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

DrugPatentWatch^® Generic Entry Outlook for Klisyri

Klisyri was eligible for patent challenges on December 14, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 7, 2038. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for KLISYRI

International Patents:	117
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Patent Applications:	462
Drug Prices:	Drug price information for KLISYRI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KLISYRI
What excipients (inactive ingredients) are in KLISYRI?	KLISYRI excipients list
DailyMed Link:	KLISYRI at DailyMed

See drug prices for KLISYRI

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

NDA:

213189

Dosage:

OINTMENT;TOPICAL

^*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.

Pharmacology for KLISYRI

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

Paragraph IV (Patent) Challenges for KLISYRI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KLISYRI	Ointment	tirbanibulin	1%	213189	1	2024-12-16

US Patents and Regulatory Information for KLISYRI

KLISYRI is protected by eight US patents and two FDA Regulatory Exclusivities.

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
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes			Y	Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes			Y	Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes			Y	Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes			Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes

EU/EMA Drug Approvals for KLISYRI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Almirall, S.A.	Klisyri	tirbanibulin	EMEA/H/C/005183Klisyri is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.	Authorised	no	no	no	2021-07-16

International Patents for KLISYRI

When does loss-of-exclusivity occur for KLISYRI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

Russian Federation

Singapore

South Korea

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KLISYRI around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20190141661	광선 각화증의 치료 및/또는 예방 방법
Japan	2023015269	光線角化症を治療および／または予防する方法
France	21C1064
South Korea	20190141661	광선 각화증의 치료 및/또는 예방 방법
Japan	2025029010	光線角化症を治療および／または予防する方法 (METHODS OF TREATING AND/OR PREVENTING ACTINIC KERATOSIS)
China	104230793

Supplementary Protection Certificates for KLISYRI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1836169	SPC/GB22/002	United Kingdom		PRODUCT NAME: TIRBANIBULIN; REGISTERED: UK EU/1/21/1558(FOR NI) 20210719; UK FURTHER MA ON IPSUM 20210719
1836169	C202130061	Spain		PRODUCT NAME: TIRBANIBULINA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1558; DATE OF AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1558; DATE OF FIRST AUTHORISATION IN EEA: 20210716
1836169	LUC00235	Luxembourg		PRODUCT NAME: KLISYRI - TIRBANIBULINE; AUTHORISATION NUMBER AND DATE:
1836169	CR 2021 00042	Denmark		PRODUCT NAME: TIRBANIBULIN, ELLER ET SALT, SOLVAT ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/21/1558 20210719
1836169	C01836169/01	Switzerland		FORMER OWNER: ATHENEX, INC., US
1836169	CA 2021 00042	Denmark		PRODUCT NAME: TIRBANIBULIN, ELLER ET SALT, SOLVAT ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/21/1558 20210719

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: KLISYRI

Last updated: July 27, 2025

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Introduction

KLISYRI (rilzabrutinib) is an oral, targeted Bruton’s tyrosine kinase (BTK) inhibitor developed by Kyverna Therapeutics, primarily designed to treat multiple autoimmune diseases, such as multiple sclerosis (MS) and potentially other B-cell mediated disorders. Its development comes amid a shifting landscape of autoimmune therapy, emphasizing precision medicine and targeted interventions. This report analyzes the current market dynamics, competitive landscape, regulatory environment, and financial trajectory for KLISYRI, positioning it within the broader pharmaceutical ecosystem.

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Market Landscape and Demand Drivers

The global autoimmune disease therapeutics market is projected to reach approximately USD 150 billion by 2028, expanding at a compound annual growth rate (CAGR) of around 6% [1]. The demand for selective BTK inhibitors like KLISYRI is driven by a rising prevalence of autoimmune conditions, particularly multiple sclerosis, which affects over 2.8 million globally and is characterized by significant morbidity [2].

Key demand factors include:

• Unmet Medical Needs: Existing MS treatments, such as interferons and monoclonal antibodies, present limitations in efficacy and safety, prompting demand for novel oral therapies with improved safety profiles.
• Shift Toward Oral Medications: Patients and clinicians favor orally administered drugs over injectable therapies, positioning KLISYRI competitively.
• Expanding Indications: As clinical trials explore KLISYRI’s efficacy in other autoimmune disorders, broadening its potential market base.

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Competitive Environment

KLISYRI enters an arena populated by several BTK inhibitors, notably ibrutinib (imbruvica), acalabrutinib (calquence), and newer agents like orelabrutinib and evobrutinib.

• Established BTK Inhibitors: These are primarily approved for hematological malignancies but have shown promise in autoimmune conditions. For instance, evobrutinib received FDA Fast Track designation for MS, indicating competitive interest [3].
• Differentiation of KLISYRI: Kyverna emphasizes rapid onset of action and a favorable safety profile, aiming to carve a niche in autoimmune indications.

Market challenges include clinical validation hurdles and regulatory risks, as autoimmune applications of BTK inhibitors are still emerging.

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Regulatory Milestones and Challenges

KLISYRI’s journey through clinical trials has focused on demonstrating safety, tolerability, and efficacy in MS. As of 2023, results from Phase 2 trials have been promising, with reports of improved lesion activity and manageable adverse events.

Regulatory pathways are reinforced by the accelerated approval avenues in the U.S. (e.g., Breakthrough Therapy designation) and the EU. However, acceptance of BTK inhibitors as standard MS therapy hinges on definitive Phase 3 data.

Anticipated catalysts include:

• Completion of Phase 3 trials—expected in 2024.
• Regulatory submissions—likely in 2025.
• Potential fast-track designations—depending on trial outcomes.

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Financial Trajectory and Revenue Forecasts

Although KLISYRI is in clinical development, its future revenue potential depends heavily on successful commercialization, market penetration, and clinical integration.

Revenue Drivers:

• Pricing Strategies: Oral MS therapies typically command premium prices, ranging from USD 50,000 to USD 70,000 annually per patient [4].
• Market Penetration: Early adoption by neurologists and payers depends on demonstrated superiority or non-inferiority to existing options.
• Expanding Indications: Potential application in other autoimmune diseases (e.g., rheumatoid arthritis, lupus) could diversify revenue streams.

Projected Financial Trajectory:

• Short-term (2023–2025): Minimal revenues, primarily from licensing or partnership milestones, estimated in the low millions.
• Mid-term (2026–2030): Peak sales could reach USD 500 million to USD 1 billion annually if regulatory approval and market uptake are favorable.
• Long-term: Global expansion and pipeline diversification could sustain growth beyond initial indications.

Risks to revenue include clinical setbacks, regulatory delays, or competitive failures, emphasizing the need for continued investment in clinical validation and marketing.

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Market Entry and Commercial Strategy

To capitalize on market potential, Kyverna and partners will need a comprehensive commercialization plan:

• Key Opinion Leader (KOL) Engagement: Building clinical advocates among neurologists and immunologists.
• Payer Negotiations: Demonstrating value via real-world evidence and health economics assessments.
• Patient Access: Establishing distribution networks and patient support programs.

Furthermore, competitive pricing strategies could influence market share, especially as payers seek value-based arrangements amid rising drug costs.

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Implications of Healthcare Trends

Several broader trends influence KLISYRI's market and financial prospects:

• Personalized Medicine: Precision targeting of B-cell pathways remains a priority, endorsing KLISYRI’s mechanism.
• Digital Health Integration: Incorporating remote monitoring and real-world outcomes can enhance drug adoption.
• Regulatory Evolutions: Adaptations in approval processes, including expedited pathways, benefit early-stage innovative therapies like KLISYRI.

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Key Challenges and Considerations

• Clinical Efficacy Validation: Definitive Phase 3 data are critical for market credibility.
• Safety Profile Establishment: Long-term safety data are essential, especially for autoimmune indications.
• Market Competition: Existing therapies and upcoming agents could limit penetration.
• Pricing and Reimbursement Dynamics: Payers may demand substantial evidence of cost-effectiveness.

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Conclusion: Strategic Outlook

KLISYRI stands at a pivotal point, with promising early data and favorable market dynamics. Its potential to carve out a niche in autoimmunity, especially multiple sclerosis, hinges on successful trial completion, regulatory approval, and strategic commercialization. The evolving landscape of BTK inhibitors and targeted immunotherapies offers both opportunities and challenges, requiring agile adaptations in clinical and business strategies.

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Key Takeaways

• KLISYRI’s success depends on demonstrating clear clinical advantages in autoimmune diseases through pivotal trials.
• The autoimmune therapeutics market is expanding, with oral targeted therapies poised to lead growth.
• Competitive differentiation hinges on safety profile, rapid onset, and broader indication opportunities.
• Financial forecasts suggest significant revenue potential if regulatory milestones are achieved, with peak sales possibly reaching USD 1 billion annually.
• Strategic engagement with clinicians, payers, and regulatory bodies will be critical in realizing market access and revenue growth.

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FAQs

1. What is KLISYRI and what indications is it targeting?
KLISYRI (rilzabrutinib) is a BTK inhibitor under development primarily for multiple sclerosis and potentially other autoimmune disorders. Its mechanism involves modulation of B-cell activity to reduce autoimmune responses.

2. When is KLISYRI expected to receive regulatory approval?
Based on current clinical trial timelines, regulatory filings could occur as early as 2025, contingent on successful completion of Phase 3 trials and submission outcomes.

3. How does KLISYRI compare to existing MS therapies?
KLISYRI offers an oral, targeted approach with potential advantages in safety and onset of action. However, its comparative efficacy will need validation through late-stage trials.

4. What are the competitive threats to KLISYRI’s market success?
Established BTK inhibitors in hematology, other oral disease-modifying therapies for MS, and emerging biologics pose competition, emphasizing the need for clear differentiation.

5. What are the risks that could impact KLISYRI’s financial trajectory?
Risks include clinical trial failures, regulatory setbacks, unfavorable cost-effectiveness assessments, and intense market competition, which could delay or diminish revenue streams.

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References

[1] Grand View Research, "Autoimmune Disease Therapeutics Market Size, Share & Trends Analysis," 2022.
[2] Multiple Sclerosis International Federation, "Global MS Data 2021."
[3] FDA, "Fast Track Designations for BTK inhibitors," 2022.
[4] IQVIA Institute, "The Price of Innovation in Multiple Sclerosis," 2021.