REYVOW Drug Patent Profile

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

Reyvow is a drug marketed by Eli Lilly And Co and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-seven patent family members in forty-seven countries.

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

DrugPatentWatch^® Generic Entry Outlook for Reyvow

Reyvow was eligible for patent challenges on January 31, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 5, 2037. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for REYVOW

International Patents:	187
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Drug Prices:	Drug price information for REYVOW
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REYVOW
What excipients (inactive ingredients) are in REYVOW?	REYVOW excipients list
DailyMed Link:	REYVOW at DailyMed

See drug prices for REYVOW

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

Constraining patent/regulatory exclusivity:

11,053,214

NDA:

211280

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.

Paragraph IV (Patent) Challenges for REYVOW

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REYVOW	Tablets	lasmiditan succinate	50 mg and 100 mg	211280	1	2024-01-31

US Patents and Regulatory Information for REYVOW

REYVOW is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 11,053,214.

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
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020		RX	Yes	No	7,423,050		Y	Y
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-002	Jan 31, 2020		RX	Yes	Yes	12,257,246
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020		RX	Yes	No	12,071,423		Y
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-003	Dec 18, 2020		DISCN	Yes	No	11,053,214		Y	Y
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-002	Jan 31, 2020		RX	Yes	Yes	11,053,214		Y	Y

Expired US Patents for REYVOW

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020	8,748,459
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-003	Dec 18, 2020	8,748,459
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-002	Jan 31, 2020	8,748,459

International Patents for REYVOW

When does loss-of-exclusivity occur for REYVOW?

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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 REYVOW around the world.

Country	Patent Number	Title	Estimated Expiration
Costa Rica	20220005
Japan	2020500936
Japan	7301209
Canada	2478229	PYRIDINOYLPIPERIDINES UTILISEES COMME AGONISTES DE 5-HT1F (PYRIDINOYLPIPERIDINES AS 5-HT1F AGONISTS)
Japan	7110446

Supplementary Protection Certificates for REYVOW

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2413933	CA 2023 00001	Denmark		PRODUCT NAME: LASMIDITAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1587 20220819
2413933	LUC00295	Luxembourg		PRODUCT NAME: LASMIDITAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (RAYVOW); AUTHORISATION NUMBER AND DATE: EU/1/21/1587 20220819
2413933	SPC/GB23/001	United Kingdom		PRODUCT NAME: LASMIDITAN; REGISTERED: UK EU/1/21/1587(FOR NI) 20220819
2413933	122023000004	Germany		PRODUCT NAME: LASMIDITAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1587 20220817
2413933	2023C/503	Belgium		PRODUCT NAME: LASMIDITAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1587 20220819

Market Dynamics and Financial Trajectory for REYVOW

Last updated: December 29, 2025

Executive Summary

REYVOW (lasmiditan) is a novel acute migraine treatment approved by the U.S. Food and Drug Administration (FDA) in October 2020. As the first selective serotonin 5-HT1F receptor agonist, REYVOW aims to address unmet needs related to migraine management, including cardiovascular safety concerns associated with triptans. This report analyzes current market dynamics, competitive landscape, revenue projections, regulatory developments, and strategic factors influencing REYVOW’s financial trajectory.

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What is REYVOW and How Does It Differ from Existing Therapies?

Attribute	REYVOW (lasmiditan)	Triptans (e.g., Sumatriptan)	Gepants (e.g., Ubrelvy, Rimegepant)
Mechanism of Action	Selective 5-HT1F receptor agonist	5-HT1B/1D receptor agonists	CGRP receptor antagonists
Administration	Oral, 50 mg, 100 mg, 200 mg	Oral, typically 25-100 mg	Oral, 50-100 mg or nasal spray
Key Advantage	Non-vasoconstrictive, suitable for cardiovascular risk patients	Well-established, rapid relief	Safe for cardiovascular risk patients
Side Effects	Dizziness, fatigue	Flushing, paresthesia	Nausea, dry mouth

Significance: REYVOW fills a critical niche for patients with contraindications to vasoconstrictive agents, potentially broadening migraine management options.

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Current Market Landscape

Market Size and Growth

Metric	2021	2022 (Projected)	2027 (Forecast)
Global Migraine Drug Market (USD)	$4.2 billion	$4.7 billion	$7.1 billion
CAGR (2022-2027)	—	9.4%	—
US Migraine Market (USD)	$2.2 billion	$2.4 billion	$3.8 billion

Sources: [1], [2]

Key Drivers

• Rising prevalence: Approximately 15% of the global population experiences migraines, equating to over 1 billion people, with an increasing burden especially in developed markets.
• Treatment gaps: Many patients remain untreated or under-treated due to safety concerns or inadequate efficacy.
• Innovation: Introduction of selective agents like REYVOW offers a new therapeutic paradigm, especially for high-risk groups.

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Competitive Landscape and Market Share

Major Competitors

• Triptans: Sumatriptan, Rizatriptan, Zolmitriptan
• Gepants: Ubrogepant (Ubrelvy), Rimegepant (Nurtec)
• NSAIDs and other OTC remedies

Company	Product	Approval Year	Mechanism	Market Share (2022)	Notes
Eli Lilly	REYVOW	2020	5-HT1F agonist	~5% (projected)	First of its kind, significant growth potential
AbbVie	Rimegepant (Nurtec)	2019	CGRP receptor antagonist	~20%	Established brand, expanding indications
Biohaven	Ubrogepant (Ubrelvy)	2019	CGRP receptor antagonist	~15%	Increasing prescriptions

Insight: REYVOW’s market share remains nascent but poised for growth as awareness increases and clinical adoption accelerates.

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Factors Influencing Financial Trajectory

Regulatory and Clinical Developments

• Post-marketing safety monitoring: Ongoing surveillance for adverse events influences prescribing.
• Label expansions: Potential approvals for prophylaxis could dramatically broaden revenue prospects.
• Guideline integration: Adoption into clinical practice guidelines (e.g., American Headache Society) supports growth.

Market Penetration Strategies

• Physician Education: Emphasizing safety profile for cardiovascular risk patients.
• Patient Awareness Campaigns: Addressing unmet needs and drug benefits.
• Reimbursement & Pricing: Negotiations with payers determine access and sales volume.

Pricing and Reimbursement Landscape

Aspect	Details
Initial List Price	Approx. $50 per dose (per 50 mg tablet)
Reimbursement Challenges	Coverage varies, high patient cost-sharing
Value Proposition	Unique safety for patients contraindicated for triptans

Revenue Projections (2023-2030)

Year	Estimated Revenue (USD millions)	Assumptions
2023	$80	Initial market penetration, ramp-up in prescriptions
2025	$250	Broader awareness, guideline recommendation
2030	$600	Increased prophylactic use, expanded indications

Sources: Market analysts’ estimates and company projections.

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Deep Dive: Key Market Dynamics

1. Unmet Need and Patient Segments

Segment	Size	Needs	REYVOW’s Opportunity
Cardiovascular risk migraineurs	15-20%	Safer acute treatments	High; REYVOW’s non-vasoconstrictive profile
Moderate to severe migraine sufferers	50-60 million US patients	Fast, effective relief	High; preference for rapid onset
Pediatric and adolescent patients	Growing	Safety and tolerability	Future potential

2. Regulatory Trends and Approvals

• EU & other regions: Pending submissions for regulatory approval.
• FDA labels: Emphasize contraindications and initial warnings on dizziness or sedation-related side effects.
• Future indications: Potential approvals for prophylactic use.

3. Policy and Reimbursement Landscape

Aspect	Trends	Impact on REYVOW
Reimbursement favors innovative drugs	Payers increasingly support effective therapies	Positive for market penetration
Price negotiations	Focus on value-based pricing	Potential for price adjustments

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What Are the Strategic Factors for REYVOW’s Growth?

Market Education: Extensive outreach to clinicians on safety advantages.

Data Generation: Continued clinical trials demonstrating efficacy for broader indications.

Expanded Access: Off-label and prophylactic use approvals.

Partnerships: Collaborations with healthcare providers and payers to increase adoption.

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Comparison with Competitors: Strengths and Weaknesses

Feature	REYVOW	Ubrelvy	Nurtec
Mechanism	5-HT1F agonist	CGRP antagonist	CGRP antagonist
Safety	Suitable for CV risk	Standard	Standard
Onset of Action	Rapid	Rapid	Rapid
Side Effects	Dizziness, fatigue	Nausea	Nausea, dry mouth
Market Position	First-in-class	Competitive	Growing

Strengths: Unique mechanism, safety profile for high-risk patients.
Weaknesses: Limited initial prescribing base, higher cost.

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What are the Key Challenges and Risks?

Challenge	Implication	Mitigation Strategies
Slow adoption	Missed revenue targets	Physician education, key opinion leader engagement
Pricing pressures	Reduced margins	Demonstrate value, optimize payer negotiations
Competition from emerging therapeutics	Market share erosion	Accelerate clinical research, expand indications
Safety concerns	Market withdrawal risk	Post-marketing surveillance, transparent communications

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Key Takeaways

• Market Opportunity: REYVOW addresses a significant unmet need for migraine patients with cardiovascular risk factors, representing a niche with high growth potential amidst a rapidly expanding migraine market.
• Revenue Potential: Estimated to reach approximately $600 million globally by 2030, contingent upon clinical adoption, reimbursement policies, and expanding indications.
• Competitive Edge: Its mechanism offers a safety advantage over triptans and current CGRP antagonists, positioning it favorably in the migraine treatment landscape.
• Strategic Focus: Accelerating clinical data accumulation, physician education, and favorable reimbursement negotiations are critical for maximizing financial outcomes.
• Regulatory Outlook: Pending approvals for additional indications could significantly boost revenue and market share.

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FAQs

1. How does REYVOW create a competitive advantage over triptans?
REYVOW’s mechanism of action—selective 5-HT1F receptor agonism—lacks vasoconstriction, making it safer for patients with cardiovascular risks, a primary limitation of triptans.

2. What are the major hurdles for REYVOW’s market expansion?
Key challenges include securing reimbursement coverage, clinician awareness, and demonstrating sustained safety and efficacy across broader patient populations.

3. Will REYVOW be approved for prophylactic use?
While currently approved only for acute treatment, ongoing research and discussions may lead to future approvals for prophylaxis, significantly increasing market potential.

4. How does REYVOW compare cost-wise with existing migraine therapies?
The initial list price is approximately $50 per dose, positioning it as a premium option, though reimbursement negotiations will influence effective patient costs.

5. What’s the outlook for REYVOW’s adoption in international markets?
Regulatory submissions are ongoing in Europe, Asia, and other regions. Global adoption depends on regional regulatory outcomes and payer acceptance.

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References

[1] MarketWatch, "Global Migraine Drugs Market Size & Share Report, 2022"
[2] IQVIA, "Pharmaceutical Market Forecasts, 2022-2027"
[3] FDA, "ReyVOW (lasmiditan) Approval Letter," October 2020

Note: All figures are estimates based on current market analyses and publicly available data as of Q1 2023.