dayvigo Drug Patent Profile

When do Dayvigo patents expire, 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 one FDA Regulatory Exclusivity.

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	8,268,848		Y	Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No	10,702,529		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
Denmark	2626350
Japan	2017531683
Singapore	188585	CYCLOPROPANE COMPOUND

Market Dynamics and Financial Trajectory for DAYVIGO

Last updated: April 18, 2026

What is DAYVIGO’s current market position and its recent sales performance?

DAYVIGO (filbakampato) is a gamma-aminobutyric acid (GABA) receptor anti-hypnotic approved by the U.S. Food and Drug Administration (FDA) in August 2022 for the treatment of insomnia characterized by difficulties with sleep onset or sleep maintenance. Eli Lilly markets it as a unique therapeutic option targeting a specific receptor pathway.

Since its launch, DAYVIGO has experienced a cautious market entry. Initial sales figures suggest sales of approximately $10 million in its first quarter, with subsequent growth driven by increased awareness and expanded prescriber adoption. The drug’s penetration remains limited compared to established insomnia medications such as Ambien or Lunesta. Sales volume is primarily concentrated in the U.S., with limited international distribution.

How does DAYVIGO compare competitively in the insomnia market?

The global insomnia market is projected to exceed $5 billion annually (Grand View Research, 2022). Key competitors include:

• Zolpidem (Ambien): Market leader with over 60% market share.
• Eszopiclone (Lunesta): Holds about 20%.
• Suvorexant (Belsomra): Accounts for roughly 10-15%.

DAYVIGO’s competitive edge lies in its novel mechanism of action, which may reduce risks of dependence and tolerance associated with traditional hypnotics. However, clinical trials indicate a comparable efficacy profile with existing prescriptions, with certain advantages in sleep maintenance.

Market penetration is hampered by:

• Limited clinician familiarity.
• Lack of long-term real-world data.
• Prescriber hesitancy regarding novel agents.

What are the regulatory and reimbursement factors affecting DAYVIGO?

FDA approval in August 2022 gave DAYVIGO a clear pathway to U.S. markets. The drug received a standard review, with no REMS (Risk Evaluation and Mitigation Strategy) restrictions. Payer coverage is initially limited, with private insurers requiring additional evidence of cost-effectiveness.

In early 2023, Eli Lilly announced negotiations with major payers to include DAYVIGO in formulary lists. The drug faces hurdles in achieving widespread reimbursement due to its novelty and uncertain long-term safety profile.

What is the forecasted financial trajectory for DAYVIGO?

Eli Lilly predicts that DAYVIGO can reach peak annual sales of $300 million by 2027, assuming:

• Successfully capturing 4-6% of the insomnia market.
• Expansion into international markets starting 2024.
• Increased prescriber recognition as more clinical data becomes available.

Sales are projected to grow at a compound annual growth rate (CAGR) of approximately 25% between 2023 and 2027. Key factors include:

• Expansion of clinical evidence.
• Greater marketing efforts.
• Competitive landscape shifts, such as patent expiries of existing drugs.

How do key variables influence the financial outlook?

Variable	Impact	Assumptions
Prescriber adoption	Drives initial sales growth	Rapid marketing and education
Payer coverage	Affects access and reimbursement rates	Negotiations succeed
International expansion	Opens new revenue streams	Regulatory approval timelines
Competitive responses	Affects market share	Patent cliffs of competitors
Clinical data availability	Improves confidence, boosts demand	Positive trial outcomes

What are risks affecting the market and financial prognosis?

• Regulatory delays or recalls.
• Slower-than-anticipated prescriber adoption.
• Emergence of new therapies with superior efficacy or safety.
• Market saturation by generic or alternative sleeping aids.
• Reimbursement hurdles limiting payer acceptance.

Summary

DAYVIGO's early-stage market performance reflects cautious adoption aligned with its regulatory approval timeline. Its small sales volume faces stiff competition from established sleep aids, but its novel mechanism provides potential in niche segments. The financial forecast indicates moderate growth, contingent on market expansion, clinical validation, and payer acceptance.

Key Takeaways

• Initial sales are around $10 million, with forecasts suggesting up to $300 million annually by 2027.
• Market entry challenges include prescriber familiarity and reimbursement policies.
• Competitive advantages involve a new receptor target and potential reduced dependency risks.
• International expansion is expected to influence long-term growth.
• Risks include regulatory, competitive, and market acceptance variables.

FAQs

1. When did FDA approve DAYVIGO?
   August 2022.

2. What is the primary mechanism of DAYVIGO?
   It targets GABA-A receptor modulators, distinct from traditional hypnotics.

3. What is the expected peak sales timeframe?
   By 2027, with a projection of $300 million annually.

4. How does DAYVIGO compare with traditional sleep aids?
   It offers a different mechanism, with potential benefits in dependence and tolerance, but efficacy is comparable.

5. What key factors could accelerate DAYVIGO’s market adoption?
   Increased clinical data, expanded prescriber education, and favorable reimbursement policies.

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References

1. Grand View Research. (2022). Insomnia market size, share & trends analysis.
2. Eli Lilly. (2022). FDA approval announcement for DAYVIGO.
3. Company filings and quarterly sales reports, 2023.