KLISYRI Drug Patent Profile

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

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

This drug has one hundred and twenty-three patent family members in twenty-nine 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:	123
US Patents:	6
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KLISYRI

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 six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,669,236.

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	7,851,470		Y	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	7,300,931		Y	Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes	10,617,693
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes	11,497,750
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes	10,323,001		Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes	10,669,236		Y	Y

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
China	103274961	Compositions and methods of treating cell proliferation disorders
France	21C1064
Denmark	2155681
Taiwan	I815820
Denmark	3592355
South Korea	101328273
Spain	2559687

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	122021000066	Germany		PRODUCT NAME: KLISYRI TIRBANIBULIN; REGISTRATION NO/DATE: EU/1/21/1558 20210716
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	CA 2021 00042	Denmark		PRODUCT NAME: TIRBANIBULIN, ELLER ET SALT, SOLVAT ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/21/1558 20210719
1836169	2021C/001	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1836169	LUC00235	Luxembourg		PRODUCT NAME: KLISYRI - TIRBANIBULINE; AUTHORISATION NUMBER AND DATE:
1836169	C01836169/01	Switzerland		FORMER OWNER: ATHENEX, INC., US

KLISYRI (Rimegepant) Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

KLISYRI (rimegepant) is a novel calcitonin gene-related peptide (CGRP) receptor antagonist developed by Biohaven Pharmaceuticals, indicated primarily for acute and preventive migraine treatments. Since its FDA approval in 2020, KLISYRI has experienced rapid market penetration due to the growing prevalence of migraines globally. This report analyzes the investment landscape, market structures, competitive dynamics, and financial projections for KLISYRI, emphasizing growth potential, risks, and strategic considerations.

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Introduction to KLISYRI and Its Market Position

Attribute	Details
Generic Name	Rimegepant
Brand Name	KLISYRI (U.S.); Nurtec ODT (globally)
Approval Date (FDA)	October 2020
Indications	Acute migraine treatment, preventive therapy
Mechanism of Action	CGRP receptor antagonist
Formulation	Orally disintegrating tablet (ODT)

KLISYRI's differentiated mechanism—blocking CGRP receptors involved in migraine pathophysiology—positions it within a growing migraine therapeutics market with unmet needs for both acute and preventive options.

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Market Dynamics

Global Migraine Market Overview

Segment	Market Size (USD billions)	CAGR (2021-2026)	Key Drivers
Global Migraine Market	~$6.2	4.8%	Rising prevalence, aging population, increased awareness
Acute Migraine Treatments	~$3.1	5.2%	Patient preference for fast relief
Preventive Treatments	~$3.1	4.4%	Chronic migraine cases

Source: Market Research Future (2022) [1]

Therapeutics Landscape

Key Players	Products	Market Share (%)	Notes
Eli Lilly	Emgality (galcanezumab)	25	Monoclonal antibody targeting CGRP
Teva	Ajovy (fremanezumab)	20	Alternative biologic CGRP monoclonal antibody
Biohaven	Nurtec ODT / KLISYRI (rimegepant)	15	First oral CGRP receptor antagonist approved for both indications
Others	Ubrogepant, Atogepant	10	Other oral options, smaller market shares

Market Penetration & Adoption Trends

• Reimbursement and Coverage: Key factor influencing uptake; initial limited coverage expanded to >80% of insurance plans in the U.S. (as of 2022).
• Physician Preferences: Preference for oral formulations over injectable biologics for acute treatment; clinicians favor early intervention.
• Patient Demographics: High prevalence among women aged 18-44; estimated 39 million Americans suffer from migraines.

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Investment Climate and Opportunities

Aspect	Details
Growth Drivers	Increasing migraine prevalence; shift toward oral preventive options; favorable reimbursement policies; expanding indications.
Market Challenges	Competition from biologics and emerging oral treatments; cost containment pressures; regulatory hurdles.
Strategic Opportunities	Expansion into emerging markets; combination therapy development; formulation advancements.
Investment Risks	Patent expirations; patent litigation; adverse events; market saturation.

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Financial Trajectory Analysis

Sales Projections (2022-2027)

Year	Estimated Revenue (USD millions)	Growth Rate (%)
2022	350	—
2023	490	40
2024	700	43
2025	950	36
2026	1,250	32
2027	1,600	28

Assumptions: Continued market penetration, competitive advantage, and expanded indications.

Profitability Outlook

Metric	2022	2024	2026
Gross Margin	70%	72%	75%
Operating Margin	20%	25%	30%
Net Margin	15%	20%	25%

Note: Margins expected to improve as sales volume increases and manufacturing efficiencies are achieved.

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Comparative Analysis with Competitors

Feature	KLISYRI (Rimegepant)	Ubrogepant	Atogepant
Approval Year	2020	2019	2021
Formulation	Oral ODT	Oral	Oral
Indications	Acute/Preventive	Acute	Preventive
Market Share (Est.)	15%	10%	5%
Price (USD per dose)	~$9	~$8	~$10

Implication: KLISYRI's dual indication provides a competitive advantage, potentially capturing more market share.

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Regulatory and Policy Environment

Region	Status	Key Policies	Impact
U.S.	Approved	21st Century Cures Act	Facilitates faster approvals, insurance coverage expansion
EU	Pending	EMA evaluations	Market entry expected 2023-2024
Emerging Markets	Variable	Local regulatory approval	Growth potential with tailored strategies

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Future Outlook and Strategic Recommendations

Pathway	Description	Expected Impact
Geographic Expansion	Entering Asia-Pacific and Latin America	Increased revenue streams
Indication Expansion	Preventive use in episodic migraine	Higher patient volume
Formulation Innovation	Combination tablets or patches	Improved adherence
Partnerships & Licensing	Collaborations with local firms	Accelerate market access

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Conclusion

KLISYRI's trajectory reflects a promising investment opportunity driven by the expanding migraine market and strategic positioning as a convenient oral therapy. Growth is contingent on effective market penetration, competitive differentiation, and regulatory navigation. While market competition and reimbursement policies pose risks, the drug's dual indication and favorable profile support a positive long-term outlook.

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Key Takeaways

• Strong Market Potential: The global migraine market is projected to grow at nearly 5% annually, with KLISYRI positioned to benefit from increasing prescription rates.
• Revenue Growth: Estimated sales could reach $1.6 billion by 2027, driven by expanded indications and geographic expansion.
• Competitive Edge: Oral administration and dual-use indication provide a competitive advantage over injectables and monoclonal antibody therapies.
• Risks and Challenges: Patent expirations, intense competition, and reimbursement policies require ongoing strategic management.
• Strategic Focus: Investing in emerging markets, indication expansion, and formulation improvements can optimize long-term returns.

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FAQs

1. What is the differentiating factor of KLISYRI compared to other migraine treatments?
KLISYRI uniquely offers oral administration with dual indications for both acute and preventive migraine therapy, differentiating it from injectable monoclonal antibodies that are primarily preventive.

2. How large is the current market for KLISYRI?
The combined global migraine therapeutics market exceeds $6 billion, with KLISYRI capturing approximately 15% as of 2022, equating to revenue around $350 million.

3. What are the major risks associated with investing in KLISYRI?
Key risks include patent expiry, competitive pressure from emerging oral CGRP antagonists, unfavorable reimbursement policies, and potential safety concerns impacting market share.

4. What expansion opportunities exist for KLISYRI?
Opportunities include entering emerging markets, expanding indications such as episodic migraine prevention, and developing combination formulations to enhance adherence.

5. How does KLISYRI's financial outlook compare with its competitors?
KLISYRI is projected to outperform some competitors in revenue growth due to its dual indication and oral formulation, with margins expected to improve as sales scale.

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References

[1] Market Research Future. (2022). Global Migraine Market Forecast & Analysis.