LASMIDITAN SUCCINATE - Generic Drug Details

What are the generic sources for lasmiditan succinate and what is the scope of freedom to operate?

Lasmiditan succinate is the generic ingredient in one branded drug marketed by Eli Lilly And Co and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lasmiditan succinate has one hundred and eighty-seven patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for LASMIDITAN SUCCINATE

International Patents:	187
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LASMIDITAN SUCCINATE
DailyMed Link:	LASMIDITAN SUCCINATE at DailyMed

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

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.

Anatomical Therapeutic Chemical (ATC) Classes for LASMIDITAN SUCCINATE

N02CC	Selective serotonin (5HT1) agonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for LASMIDITAN SUCCINATE

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 LASMIDITAN SUCCINATE

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	211280-002	Jan 31, 2020		RX	Yes	Yes
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020		RX	Yes	No			Y	Y
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020		RX	Yes	No			Y
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-003	Dec 18, 2020		DISCN	Yes	No

Expired US Patents for LASMIDITAN SUCCINATE

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
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-003	Dec 18, 2020
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-002	Jan 31, 2020

International Patents for LASMIDITAN SUCCINATE

Country	Patent Number	Title	Estimated Expiration
Mexico	2021014139
South Africa	202303699
Lithuania	3551617
China	107412230

Supplementary Protection Certificates for LASMIDITAN SUCCINATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2413933	2390001-2	Sweden		PRODUCT NAME: LASMIDITAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1587 20220819
2413933	CA 2023 00001	Denmark		PRODUCT NAME: LASMIDITAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1587 20220819
2413933	2023C/503	Belgium		PRODUCT NAME: LASMIDITAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1587 20220819
2413933	PA2023502,C2413933	Lithuania		PRODUCT NAME: LASMIDITANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/21/1587 20220817

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Lasmiditan Succinate

Last updated: July 27, 2025

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Introduction

Lasmiditan succinate, marketed under brand names such as Reyvow by Eli Lilly and Co., represents a novel therapeutic approach in the acute treatment of migraine. As a selective serotonin 1F (5-HT1F) receptor agonist, lasmiditan offers a new mechanism of action differing from traditional triptans, positioning it uniquely in the migraine market. This analysis evaluates the current market dynamics and forecasts the financial trajectory of lasmiditan succinate, considering competitive landscape, regulatory environment, market adoption, and potential revenue streams.

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Market Overview and Therapeutic Positioning

Migraine remains a pervasive neurological disorder, affecting approximately 1 billion individuals globally, with significant socio-economic impacts due to reduced productivity and healthcare costs [1]. Traditionally, triptans dominated the acute migraine treatment space, but their vasoconstrictive effects limited use among cardiovascular risk patients.

Lasmiditan, launched in 2019 after FDA approval, entered the market as a non-vasoconstrictive option that addresses unmet needs for patients with cardiovascular contraindications to triptans. Its mechanism—selective 5-HT1F receptor activation—minimizes cardiovascular effects, broadening its target patient population. As a result, lasmiditan targets a niche within the migraine market, especially among high-risk individuals.

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Market Dynamics

Competitive Landscape

Lasmiditan operates in a competitive environment with existing acute migraine therapies. Triptans, including sumatriptan and rizatriptan, maintain dominant market shares but bear limitations concerning contraindications. Newer therapies such as "gepants" (ubrogepant and rimegepant) also target the non-vasoconstrictive niche; however, they differ in mode of administration—often oral or injectable—while lasmiditan is primarily available as an oral tablet.

The rise of gepants introduces direct competition, with the latter demonstrating rapid onset and favorable safety profiles, including use during pregnancy and among cardiovascular patients. Nonetheless, lasmiditan's unique mechanism provides an alternative for highly specific patient subsets, enabling niche market retention.

Regulatory and Reimbursement Influences

Regulatory approval pathways for lasmiditan set a precedent for its market entry. The drug received FDA approval based on clinical trials demonstrating efficacy in acute migraine relief [2]. However, insurance coverage and reimbursement policies significantly influence market penetration.

Reyvow's pricing, approximately $30 to $40 per dose, faces scrutiny balancing high retail costs against added value for patients contraindicated for triptans. Payer willingness to reimburse hinges on demonstrated real-world benefits and comparative effectiveness.

Market Adoption and Prescriber Behavior

Initial uptake has faced hurdles owing to safety concerns, such as dizziness and somnolence linked to central nervous system effects. Educating clinicians about appropriate patient selection and managing adverse effects is crucial for expanding the prescribing base.

Furthermore, the preference for established therapies among physicians constrains rapid adoption. However, continued differentiation through clinical data indicating superiority in specific patient groups enhances confidence in prescribing lasmiditan.

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Financial Trajectory and Revenue Outlook

Historical Sales and Growth Drivers

Eli Lilly reported that Reyvow achieved approximately $27 million in U.S. sales in 2021, with sales ramping up amid increased migraine awareness and prescribing [3]. Early success is driven by a relatively small but expanding patient base requiring alternatives to triptans.

Forecasting Sales and Market Penetration

Future revenue hinges on a combination of factors:

• Market Expansion: As awareness grows and prescriber familiarity increases, sales are expected to rise steadily over 3–5 years.
• Patient Population Growth: With migraine prevalence stabilizing and the potential for intensified use among high-risk patients, the target market remains sizable.
• Competitive Dynamics: Introduction of gepants and potential future therapies could compress market share if they demonstrate better profiles or lower costs.

Analysts project that by 2025, annual lasmiditan sales in North America could surpass $150 million, assuming a compounded annual growth rate (CAGR) of approximately 20% from current levels. Long-term projections suggest potential revenues approaching $300 million globally, especially if expanded indications or formulations (e.g., injections) are approved.

Pricing and Cost-Effectiveness Considerations

Pricing strategies will significantly influence revenue trajectories. While high-cost positioning may limit access, demonstrated cost-effectiveness via reduced healthcare utilization and improved quality of life could justify premium pricing. Payers are increasingly adopting value-based frameworks, favoring therapies that demonstrate tangible benefits over existing options.

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Regulatory and Market Evolution Factors

Emerging data from real-world evidence and post-marketing studies will shape the drug's financial trajectory. Ongoing research exploring the efficacy and safety profile of lasmiditan in diverse patient populations could unlock expanded indications, further bolstering sales.

Additionally, regulatory bodies' acceptance of biosimilars or generics could impact revenues, assuming patent protections are eventually challenged or expire.

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Strategic Opportunities and Challenges

• Opportunities: Developing combination formulations, expanding into prophylactic indications, or entering markets with underserved populations could increase revenues.

• Challenges: Competition from newer agents, safety concerns, high pricing, and payer resistance pose ongoing hurdles.

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Key Takeaways

• Niche Market Position: Lasmiditan's unique mechanism provides a strategic advantage in treating high-risk migraine patients, but limits its broader market share.

• Growth Potential: Guided by prescriber education, insurance coverage expansion, and ongoing clinical validation, sales are poised for growth, with projections reaching hundreds of millions globally over the next five years.

• Competitive Landscape: The emergence of gepants and potential generic competitors necessitates continuous differentiation and strategic adjustments.

• Pricing and Reimbursement: Balancing high treatment costs with demonstrated value remains pivotal in maximizing revenue.

• Regulatory and Research Advances: Expanding indications and new formulations can unlock additional revenue streams, contingent on favorable regulatory outcomes and clinical evidence.

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FAQs

1. What distinguishes lasmiditan from traditional migraine treatments?
   Lasmiditan selectively targets 5-HT1F receptors without vasoconstrictive effects, enabling use in patients contraindicated for triptans.

2. What is the current global sales outlook for lasmiditan?
   Initial U.S. sales are modest but expected to grow substantially, with projections reaching hundreds of millions of dollars within five years, driven by increased adoption and expanded indications.

3. How does competition from gepants affect lasmiditan's market potential?
   Gepants provide an alternative with similar non-vasoconstrictive profiles; however, lasmiditan retains niche appeal where its specific efficacy profile and safety are advantageous.

4. What are the main barriers to lasmiditan's market expansion?
   Safety concerns like dizziness, high treatment costs, prescriber familiarity, and payer reimbursement limitations impede broader adoption.

5. Could future patent expirations impact lasmiditan's revenue?
   Yes; eventual patent expiry could lead to generic competition, potentially reducing prices and revenues unless new formulations or indications offset losses.

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References

[1] World Health Organization. (2022). Headache disorders. WHO Fact Sheet No. 277.
[2] Food and Drug Administration. (2019). FDA approves Reyvow for treatment of migraines.
[3] Eli Lilly and Co. Annual Report 2021.