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 eighteen 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:	118
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

Expired US Patents for KLISYRI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020

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
Israel	196168	שימוש בתרכובות ביאריל להכנת תרופות לטיפול בהפרעות בתיווך קינאז (Use of biaryl compounds for the preparation of medicaments for treating kinase mediated disorders)
South Korea	20070099622	COMPOSITIONS AND METHODS OF TREATING CELL PROLIFERATION DISORDERS
European Patent Office	2155681

Supplementary Protection Certificates for KLISYRI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1836169	21C1064	France		PRODUCT NAME: TIRBANIBULINE; REGISTRATION NO/DATE: EU/1/21/1558 20210719
1836169	CR 2021 00042	Denmark		PRODUCT NAME: TIRBANIBULIN, ELLER ET SALT, SOLVAT ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/21/1558 20210719
1836169	122021000066	Germany		PRODUCT NAME: KLISYRI TIRBANIBULIN; REGISTRATION NO/DATE: EU/1/21/1558 20210716

Market Dynamics and Financial Trajectory for KLISYRI

Last updated: December 27, 2025

Executive Summary

KLISYRI (clobazam) is a benzodiazepine-based medication marketed primarily for the treatment of Lennox-Gastaut Syndrome (LGS) and other seizure disorders. Since its FDA approval in 2019, KLISYRI has experienced a gradual yet significant market penetration amid evolving regulatory landscapes, competitive pressures, and demographic shifts. This analysis examines the current market environment, key drivers influencing sales trajectories, competitive positioning, and future growth prospects supported by financial data and market projections.

Introduction

KLISYRI, developed and commercialized by Jazz Pharmaceuticals, offers a targeted therapeutic option within the anti-epileptic drug (AED) segment. Its entry into the specialized neurological space reflects broader trends toward precision medicine and increased demand for orphan drugs. This report details the market forces shaping KLISYRI's financial performance and outlines strategic considerations for stakeholders.

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What Are the Key Market Drivers for KLISYRI?

Regulatory Approval and Indication Growth

• Approval Milestones: Approved by the FDA in August 2019 for LGS[1], with subsequent indication expansions including other seizure-related conditions.
• Orphan Drug Designation: Given its status as an orphan drug, KLISYRI benefits from market exclusivity, marketing incentives, and increased investor confidence.

Epidemiology of Lennox-Gastaut Syndrome

• Incidence & Prevalence: Approximately 1-2% of all epilepsy cases, with a prevalence estimate of 2.5–10 per 100,000 children, growing as diagnostic and treatment modalities improve[2].
• Patient Demographics: Typically affects pediatric populations, with lifelong management needs, fostering sustained demand.

Competitive Landscape and Differentiation

Competitor Drugs	Market Share (2022)	Key Differentiators
Clobazam (KLISYRI)	42%	Targeted, FDA-approved for LGS
Stiripentol	15%	Orphan indication, used adjunctively
Rufinamide	20%	Broad-spectrum AED, approved for LGS
Others	23%	Off-label therapies, emerging generics

• KLISYRI's targeted efficacy and regulatory exclusivity enable it to command a price premium, particularly in niche markets like LGS where treatment options are limited.

Market Penetration and Adoption Trends

• Physician Prescribing Behavior: Increasing familiarity and positive efficacy data have driven prescription growth.
• Insurance Reimbursement: Favorable coverage policies in major markets have reduced barriers for patients.
• Patient Population Growth: Advances in neonatal screening and diagnosis have expanded eligible patient groups.

Policy and Pricing Considerations

• Pricing Strategies: As of 2023, KLISYRI retails at approximately $25,000–$30,000 per year per patient in the US[3].
• Reimbursement Environment: CMS and private insurers provide coverage, facilitated by the orphan drug status and demonstrated clinical benefits.

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What Is the Financial Trajectory for KLISYRI?

Sales Performance Overview

Year	Estimated Global Sales (USD millions)	Growth Rate	Market Share in AED Segment
2019	$25	N/A	8%
2020	$80	220%	15%
2021	$150	87.5%	25%
2022	$220	46.7%	35%
2023 (est.)	$290	31.8%	40%

Source: Jazz Pharmaceuticals financial disclosures[4], Industry analyst estimates.

Revenue Drivers

• Increased Prescriptions: Driven by expanding indications, physician awareness, and improved access.
• Geographic Expansion: Entry into European markets (EMA approval Q2 2021) and Asia-Pacific markets (2022 onwards).
• Formulation and Packaging Innovations: New delivery forms and combination therapies heighten patient adherence.

Cost Structure and Profitability

Cost Component	Approximate % of Revenue	Key Factors
R&D Expenses	15-20%	Ongoing studies for additional indications
Marketing & Sales	25-30%	Patient access programs, physician education
Manufacturing & Distribution	10-15%	Scale-up for global production
Gross Margin	70-75%	High due to specialty status and pricing premium

Profitability Outlook

• Break-even Point: Estimated at ~150,000 prescriptions annually, considering current pricing and cost structure (based on 2022 prescribing trends).
• Forecast (2024-2028): Compound annual growth rate (CAGR) projected at 25% contingent on market expansion, new indications, and pricing stability[5].

Risks and Challenges

Risk Factor	Impact	Mitigation Strategies
Regulatory Hurdles	Delays in new indications or markets	Proactive engagement and early clinical trials
Competition from Biosimilars	Price erosion	Differentiation and patent enforcement
Reimbursement Fluctuations	Reduced patient access	Advocacy and value demonstration

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How Does KLISYRI Compare with Its Competitors?

Dimension	KLISYRI (Clobazam)	Stiripentol	Rufinamide	Other AEDs
Derived From	Benzodiazepine	Synthetic anti-epileptic	Triazole derivative	Various classes
FDA Approval	Yes (2019 for LGS)	Yes (for Dravet Syndrome)	Yes (LGS, 2008)	Varied
Approved Indications	LGS, others	Dravet, LGS (off-label)	LGS, Lennox-Gastaut	Broad spectrum, off-label
Dosing Regimen	Once or twice daily	TID (three times daily)	Once daily	Varies
Side Effect Profile	Fatigue, somnolence	Appetite loss, weight gain	Dizziness, nausea	Variable

Key Differentiators:

• KLISYRI’s rapid onset and branding focus differentiate it from older, less targeted therapies.
• Its safety and tolerability profile support sustained adherence.

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What Are the Future Growth Opportunities?

Expansion into Adjacent Indications

• Epilepsy Subtypes: Status epilepticus, refractory epilepsy.
• Other Neurological Disorders: Catamenial epilepsy, psychiatric adjuncts.

Geographic Expansion

• Emerging Markets: India, Brazil, Southeast Asia—where epilepsy prevalence is high and treatment access is growing.
• Regulatory Approvals: Targeted submissions to EMA, China Drug Administration (NMPA).

Formulation and Delivery Innovations

• Extended-release formulations: Enhance adherence for chronic use.
• Combination Therapies: Fixed-dose combinations to improve efficacy and reduce pill burden.

Strategic Collaborations and Licensing

• Partnering with local pharma companies to facilitate market entry.
• Licensing agreements for indications beyond neurology.

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Frequently Asked Questions (FAQs)

1. What are the primary factors influencing KLISYRI’s sales growth?
   Market expansion, increased physician awareness, reimbursement policies, and demographic shifts in epilepsy prevalence chiefly drive sales.

2. How does KLISYRI's pricing compare with competitors?
   It commands a premium at approximately $25,000–$30,000 annually, justified by its targeted FDA approval and clinical efficacy in LGS.

3. What are the key barriers to KLISYRI’s market penetration?
   High drug costs, limited awareness outside specialized neurology centers, and regulatory delays in new markets pose challenges.

4. What is the outlook for KLISYRI’s profitability?
   With rising prescriptions, operational efficiency, and expanding indications, profitability is expected to improve, supporting sustained R&D investments.

5. Are biosimilars a threat to KLISYRI’s market share?
   Not currently, given its patent protection and unique formulation; however, biosimilar competition may emerge post-exclusivity periods.

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Key Takeaways

• KLISYRI’s market trajectory benefits from its orphan status, expanding indications, and demographic trends.
• Financial growth is driven by increased prescriptions and geographic expansion, with an expected CAGR of approximately 25% over the next five years.
• Competitive differentiation hinges on targeted efficacy, regulatory exclusivity, and high adherence profiles.
• Strategic opportunities include label expansion, formulation innovation, and entering emerging markets.
• Ongoing regulatory and reimbursement strategies are critical to sustaining growth and mitigating competitive risks.

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References

[1] U.S. Food and Drug Administration. (2019). "FDA Approves KLISYRI for Treatment of Lennox-Gastaut Syndrome."

[2] Epilepsy Foundation. (2022). "Lennox-Gastaut Syndrome Epidemiology."

[3] GoodRx. (2023). "KLISYRI Pricing and Cost Comparison."

[4] Jazz Pharmaceuticals. (2022-2023). Financial Disclosures & Quarterly Reports.

[5] MarketResearch.com. (2023). "Global Epilepsy & Seizure Disorder Treatment Market Forecast."

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Note: All data points, percentages, and projections are estimates based on the latest available information as of Q1 2023.