DAYVIGO Drug Patent Profile

Which patents cover Dayvigo, and what generic alternatives are available?

Dayvigo is a drug marketed by Eisai Inc and is included in one NDA. There are four patents protecting this drug.

This drug has fifty-five patent family members in thirty-three countries.

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

DrugPatentWatch^® Generic Entry Outlook for Dayvigo

Dayvigo was eligible for patent challenges on April 7, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 21, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DAYVIGO

International Patents:	55
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	7
Patent Applications:	123
Drug Prices:	Drug price information for DAYVIGO
What excipients (inactive ingredients) are in DAYVIGO?	DAYVIGO excipients list
DailyMed Link:	DAYVIGO at DailyMed

See drug prices for DAYVIGO

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

Constraining patent/regulatory exclusivity:

10,188,652

NDA:

212028

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.

Recent Clinical Trials for DAYVIGO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Brendan Lucey	Phase 2
Eisai Inc.	Phase 2
Eisai Co., Ltd.	Phase 2

See all DAYVIGO clinical trials

Pharmacology for DAYVIGO

Drug Class	Orexin Receptor Antagonist
Mechanism of Action	Cytochrome P450 2B6 Inducers Orexin Receptor Antagonists

US Patents and Regulatory Information for DAYVIGO

DAYVIGO is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,188,652.

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
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No	8,268,848		Y	Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-002	Apr 7, 2020		RX	Yes	Yes	10,188,652		Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No	10,702,529		Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-002	Apr 7, 2020		RX	Yes	Yes
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-002	Apr 7, 2020		RX	Yes	Yes	8,268,848		Y	Y

International Patents for DAYVIGO

When does loss-of-exclusivity occur for DAYVIGO?

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

Spain

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 DAYVIGO around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2012039371
Taiwan	I516484
Japan	2017531683	不眠症を治療するための組成物および方法
European Patent Office	3209298
South Korea	102444608

Market Dynamics and Financial Trajectory for DAYVIGO

Last updated: July 27, 2025

Introduction

DAYVIGO (lemborexant) represents a novel therapeutic in the treatment of insomnia, a condition affecting approximately 30-40% of adults worldwide. As a dual orexin receptor antagonist (DORA), DAYVIGO differentiates itself in a crowded sleep aid market dominated by benzodiazepines, non-benzodiazepine hypnotics, and melatonin receptor agonists. Its market performance, driven by regulatory approvals, clinical efficacy, safety profile, and competitive landscape, offers critical insights into its financial trajectory and overall market dynamics.

Regulatory Milestones and Market Entry

In December 2019, the U.S. Food and Drug Administration (FDA) approved DAYVIGO (lemborexant) for the treatment of adult insomnia, citing its efficacy in reducing sleep latency and wake after sleep onset, with a tolerable safety profile. The approval marked a strategic milestone for Eisai Co., Ltd., the drug’s developer, aiming to establish an innovative foothold within the sleep disorder therapeutics market.

Similarly, Japan’s Ministry of Health, Labour and Welfare approved DAYVIGO in early 2020, reinforcing its global ambitions. Regulatory clearances in Europe and other jurisdictions are under evaluation, with submissions ongoing. These approvals expand access, optimize market potential, and catalyze revenues.

Market Dynamics Influencing DAYVIGO

Competitor Landscape

The sleep aid market is highly competitive, comprising entrenched players and emerging alternatives:

• Benzodiazepines and Non-Benzodiazepine Hypnotics: Drugs like zolpidem (Ambien) and eszopiclone dominate the market, leveraging longstanding prescribing habits. Nonetheless, concerns over dependence and side effects have shifted clinicians toward alternatives.
• Orexin Receptor Antagonists: While DAYVIGO is among the first DORAs, other candidates such as Suvorexant (Belsomra) by Merck have already established a market presence. The unique dual binding mechanism of DAYVIGO offers potential differentiators in efficacy and safety.
• Other Therapeutic Modalities: Melatonin receptor agonists (ramelteon, ramelteon) and behavioral therapies also compete indirectly, influencing patient preferences and prescribing trends.

Mechanism of Action and Patient Compliance

Orexin antagonism, targeting wake-promoting neuropeptides, offers a novel treatment pathway with minimal next-day residual impairment—an advantage over traditional hypnotics. This, combined with a favorable safety profile, improves patient adherence and expands the therapeutic scope, particularly among populations concerned with dependency and cognitive impairment.

Healthcare Economics and Reimbursement

Reimbursement strategies significantly impact DAYVIGO’s financial trajectory. As a branded novel therapy, pricing strategies balance profitability with accessibility. In the U.S., insurance coverage, formulary inclusion, and pricing negotiations influence prescribing rates. Moreover, cost-effectiveness analyses demonstrating improved safety and adherence can facilitate broader payer acceptance.

Market Penetration Strategies and Geographic Expansion

Eisai’s targeted marketing campaigns, prescriber education, and partnerships with healthcare providers are crucial to gaining market share. Geographic expansion into Europe, Asia, and emerging markets hinges upon successful regulatory approval, local market dynamics, and health system structures.

Financial Trajectory Projection

Revenue Estimates and Market Share

Initial sales of DAYVIGO were modest, reflecting cautious adoption due to clinician familiarity with established treatments and the incremental nature of market entry for novel drugs. However, projections indicate robust growth potential:

• Short-term (1-3 years): Analysts project sales ranging between $300 million to $500 million globally, driven by expanding indications and increased prescriber experience.
• Medium-term (3-5 years): With broader geographic penetration and clinician acceptance, revenues may approach $1 billion annually, conditioned upon strong reimbursement policies.
• Long-term (5+ years): Market saturation, potential line extensions, and combination therapies could augment longevity and revenue streams, possibly surpassing $2 billion globally.

Factors Influencing Financial Growth

• Regulatory Expansion: Approvals in additional countries significantly amplify sales potential.
• Competitive Dynamics: The entry of next-generation DORAs or alternative therapies could temper growth if they offer superior efficacy or safety profiles.
• Pricing Strategies: Premium pricing sustains profit margins but may hinder adoption; value-based pricing aligned with clinical benefits enhances market penetrability.
• Clinical Efficacy and Real-World Data: Demonstrated superiority or unique safety attributes foster prescriber confidence and patient adherence.

Risks to Financial Outlook

• Market Saturation: Once initial growth phases mature, sales may plateau.
• Regulatory Delays or Rejections: Additional clinical hurdles could impede expansion.
• Healthcare Policy Changes: Reimbursement reforms or generic entry—post-patent expiration—could pressure profit margins.

Conclusion

The market dynamics surrounding DAYVIGO are shaped by its innovative mechanism, safety profile, competitive landscape, and regulatory environment. The drug's financial trajectory hinges on successful geographic expansion, prescriber acceptance, and market positioning as a superior insomnia therapy. While short-term revenues are promising, sustained growth depends on strategic market access, ongoing clinical research, and adaptive marketing strategies.

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Key Takeaways

• Innovative Mechanism: DAYVIGO’s dual orexin receptor antagonism offers a differentiated treatment approach with potential safety and efficacy advantages.
• Market Entry & Growth: Regulatory approvals in key markets set the stage for moderate early revenues, with significant upside as commercial adoption accelerates.
• Competitive Positioning: Differentiation from existing therapies through safety and tolerability is vital to capturing market share.
• Pricing & Reimbursement: Strategic negotiations and favorable health economics are crucial for maximizing revenue potential.
• Future Outlook: Ongoing global expansion, clinical evidence, and competitive responses will shape the long-term financial success of DAYVIGO.

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FAQs

1. What distinguishes DAYVIGO from other sleep aids?
DAYVIGO’s mechanism as a dual orexin receptor antagonist provides a novel approach to treating insomnia by targeting wakefulness pathways, offering potentially fewer side effects and lower dependence risk compared to benzodiazepines.

2. What is the current market size for DAYVIGO?
Initial estimates suggest global sales of approximately $300-$500 million within the first few years post-launch, with projections exceeding $1 billion as adoption expands.

3. How does regulatory approval impact DAYVIGO’s financial outlook?
Regulatory approvals facilitate market access and revenue generation. Delays or rejections could significantly restrict sales growth, making ongoing regulatory engagement critical.

4. What are the main risks to DAYVIGO’s market success?
Key risks include intense competition from existing therapies, market saturation, reimbursement barriers, and potential safety concerns emerging from real-world use.

5. What strategies will influence DAYVIGO’s long-term financial trajectory?
Expanding geographic reach, demonstrating clinical superiority, optimizing pricing and reimbursement strategies, and innovating with line extensions or combinations are pivotal to sustaining growth.

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References

[1] Food and Drug Administration. (2019). FDA approves new treatment for insomnia.
[2] Eisai Co., Ltd. Official Press Release. (2019). U.S. FDA approval of DAYVIGO.
[3] IQVIA. (2022). Global sleep disorder therapeutics market report.
[4] MarketWatch. (2023). Insomnia drugs market forecast.
[5] EvaluatePharma. (2023). Top-selling drugs analysis.