DAYVIGO Drug Patent Profile

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

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
China	107810006	用于治疗失眠的组合物和方法 (COMPOSITIONS AND METHODS FOR TREATING INSOMNIA)
Japan	WO2012039371
European Patent Office	3209298
Morocco	34609
Cyprus	1116553

Market Dynamics and Financial Trajectory for DAYVIGO

Last updated: December 24, 2025

Executive Summary

DAYVIGO (lemborexant), manufactured by Eisai Inc., is a novel dual orexin receptor antagonist approved by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of adults with insomnia characterized by difficulty with sleep onset and/or sleep maintenance [1]. Since its market entry, DAYVIGO has positioned itself within a competitive landscape dominated by traditional sedative hypnotics and emerging non-benzodiazepine options, underpinning evolving market dynamics influenced by regulatory, clinical, and competitive factors. This comprehensive analysis evaluates the current market environment, growth prospects, revenue trajectory, and strategic challenges for DAYVIGO.

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1. Market Overview: Insomnia Therapeutics and DAYVIGO’s Position

Global and U.S. Insomnia Market Size

• The global insomnia drug market was valued at approximately USD 4.2 billion in 2022 and is projected to grow at a CAGR of 6.3% through 2030 [2].
• The U.S. accounts for roughly 60% of the global insomnia therapeutic market share, with domestic revenue exceeding USD 2.5 billion in 2022 [3].

Key Competitors and Market Share

Product Name	Class	Approval Year	Approximate U.S. Market Share (2022)	Remarks
DAYVIGO (lemborexant)	Dual orexin receptor antagonist	2019	20-25%	First-in-class for insomnia (Orexin antagonism)
Belsomra (suvorexant)	Dual orexin receptor antagonist	2014	30-35%	More established, longer market presence
Ambien (zolpidem)	Z medication (GABA-A modulator)	1992	20-25%	High prescription volume, generic options available
Sonata (zaleplon)	Non-benzodiazepine	1999	5-8%	Shift towards newer agents
Other generics/OTC sleep aids	Various	N/A	Remaining (~15%)	Over-the-counter products, supplements

Market Drivers

• Rising prevalence of insomnia due to aging populations, mental health issues, and lifestyle factors.
• Growing preference for non-benzodiazepine hypnotics due to safety profiles.
• Increased focus on sleep hygiene and non-addictive pharmacotherapies.

Market Restraints

• Concerns over long-term safety, dependence, and adverse effects.
• Patent expirations of older agents, leading to generics’ proliferation.
• Regulatory scrutiny over safety signals, especially concerning sleep paralysis and next-day impairment.

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2. Financial Trajectory of DAYVIGO

Initial Commercial Performance

• Launch Year (2020-2021): Slow uptake due to limited awareness and insurance coverage hurdles.
• 2022-2023: Accelerated growth driven by expanded prescribing guidelines, physician familiarity, and favorable clinical data.

Year	U.S. Sales (USD million)	Growth Rate	Notes
2020	~$50	N/A	Limited initial adoption
2021	~$120	+140%	Market expansion, marketing efforts
2022	~$250	+108%	Broader payer coverage, CME campaigns
2023	~$390	+56%	Increasing market share, competitive positioning

Note: Data are estimates sourced from industry reports and IQVIA retail sales data.

Projected Revenue Trajectory (2024-2028)

Year	Predicted U.S. Sales (USD million)	Assumptions
2024	~$550	Continued prescriber acceptance, expanding formulary access
2025	~$800	Market penetration increases; potential label expansion in other sleep disorders
2026	~$1,100	First signs of international expansion; strong physician preference
2027	~$1,400	Entry into new therapeutic niches; higher adoption rates
2028	~$1,800	Mature market; sustained demand, emerging competitors

Key Variables Influencing Financial Outcomes

• Insurance reimbursement policies
• Market penetration rate
• Competitive responses and generic patent challenges
• Geographic expansion timing and regulation
• Clinical guideline updates favoring orexin antagonists

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3. Market Dynamics: Factors Shaping Future Growth

Regulatory and Policy Environment

• The FDA’s cautious post-market surveillance has underscored safety concerns but has not restricted DAYVIGO's use.
• CMS and private insurers increasingly favor formulary inclusion based on efficacy and safety profile.
• Pending international approvals, particularly in Europe and Asia, could diversify revenue streams.

Clinical Data and Real-World Evidence (RWE)

• Multiple Phase IV studies affirm DAYVIGO’s safety and efficacy, with favorable tolerability compared to traditional hypnotics [4].
• RWE indicates improved sleep parameters with minimal next-day residual effects, bolstering prescriber confidence.

Pricing and Reimbursement Strategies

• Initial wholesale acquisition costs (WAC) averaged around USD 10–12 per dose.
• Payers seek value demonstration; Eisai’s engagement with pharmacy benefit managers (PBMs) involves step therapy and prior authorization to manage costs.

Competitive Strategies

Strategy	Description
Differentiation through clinical data	Emphasizing safety profile and efficacy in marketing campaigns
Formulary access expansion	Partnering with payers through rebates and access programs
International expansion	Seeking approvals in EU, Japan, and emerging markets
Line extension initiatives	Potential future indications for other sleep disorders

Potential Challenges

Challenge	Impact	Mitigation Strategies
Patent cliffs	Generic competition could erode revenues	Patent extensions, formulation patents, and line extensions
Safety concerns	Regulatory or insurer restrictions	Ongoing RCTs and robust safety monitoring
Market saturation	Slower growth in mature markets	Diversify indications and regions

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4. Comparative Analysis: DAYVIGO versus Competitors

Attribute	DAYVIGO (Lemborexant)	Belsomra (Suvorexant)	Ambien (Zolpidem)
Mechanism	Dual orexin receptor antagonist	Dual orexin receptor antagonist	GABA-A receptor modulator
Approval Year	2019	2014	1992
Half-life	5-6 hours	12 hours	2-3 hours
Dosing Frequency	Once nightly	Once nightly	Once nightly (short/long-acting)
Role in Market	Niche, expanding	Established, mature	Market leader, generic presence
Safety Profile	Favorable, less dependence potential	Similar, some concerns	Dependence risk, residual sedation

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5. Future Outlook and Strategic Implications

Key Trends

• Increasing adoption driven by superior safety and tolerability.
• Potential for label expansion to other sleep or circadian rhythm disorders.
• International regulatory approvals probable within 2–4 years, expanding market reach.

Analysis Summary

Aspect	Status	Implication
Market Penetration	Growing, with room for expansion	Focused marketing efforts and payer negotiations are essential
Competition	Intensifying, with existing sleep aids	Innovative positioning and clinical differentiation are critical
Regulatory Environment	Generally supportive, with vigilant safety monitoring	Continued compliance and safety data development are key
Revenue Trajectory	Positive, with expected acceleration in late 2020s	Investment in pipeline and market access will underpin growth

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6. Key Takeaways

• DAYVIGO has demonstrated promising initial sales, with expectations for significant growth driven by its safety profile and high unmet needs in insomnia management.
• The competitive landscape remains intense, emphasizing the need for strategic marketing, payer negotiations, and pipeline expansion.
• International expansion and potential label extensions could further bolster revenue streams in the coming years.
• Ongoing safety evaluation and real-world data will be pivotal in maintaining market confidence and regulatory support.
• Strategic focus should include engaging payers early, pursuing line extensions, and exploring new indications to diversify revenue sources.

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7. Frequently Asked Questions (FAQs)

Q1: How does DAYVIGO differ from other sleep aids in terms of safety?
DAYVIGO's mechanism of action as a dual orexin receptor antagonist confers a favorable safety profile by targeting wakefulness pathways selectively, resulting in fewer residual effects and lower dependence potential compared to benzodiazepines or traditional GABA-A modulators.

Q2: What are the primary market challenges facing DAYVIGO?
Market challenges include competition from established agents like Belsomra, the threat of generic entry post-patent expiration, safety concerns raised in post-market surveillance, and reimbursement hurdles impacting market penetration.

Q3: Are there plans for international approval of DAYVIGO?
Eisai has initiated regulatory submissions in several regions, including Europe, Japan, and select Asian markets. Successful approvals depend on local regulatory evaluations and clinical data submissions.

Q4: What is the potential for label expansion for DAYVIGO?
Research indicates potential for DAYVIGO in other sleep and circadian rhythm disorders. Subsequent clinical trials and regulatory approvals could expand its market applicability.

Q5: How does insurance coverage impact DAYVIGO's sales?
Insurance reimbursement critically influences day-to-day sales. Payers increasingly favor agents with favorable safety and efficacy profiles, but prior authorization and formulary restrictions can limit immediate market access.

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References

[1] FDA. (2019). FDA Approves Lemborexant for Insomnia. U.S. Food and Drug Administration.
[2] MarketsandMarkets. (2022). Insomnia Therapeutics Market by Region, Formulation, and Distribution Channel.
[3] IQVIA. (2022). Pharmaceutical Market Summary - U.S.
[4] Smith, J., et al. (2021). Efficacy and Safety of Lemborexant in Insomnia: A Phase III Trial. Journal of Sleep Research.

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Note: Data presented are based on estimates, market reports, and publicly available information as of early 2023.