Lemborexant - Generic Drug Details

What are the generic sources for lemborexant and what is the scope of patent protection?

Lemborexant is the generic ingredient in one branded drug marketed by Eisai Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for lemborexant

International Patents:	55
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	38
Patent Applications:	227
What excipients (inactive ingredients) are in lemborexant?	lemborexant excipients list
DailyMed Link:	lemborexant at DailyMed

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

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 lemborexant

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

Sponsor	Phase
Virginia Commonwealth University	PHASE2
National Institute on Drug Abuse (NIDA)	PHASE2
Woolcock Institute of Medical Research	PHASE2

See all lemborexant clinical trials

Pharmacology for lemborexant

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

Anatomical Therapeutic Chemical (ATC) Classes for lemborexant

N05CJ	Orexin receptor antagonists
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

N05CM	Other hypnotics and sedatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for lemborexant

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	212028-002	Apr 7, 2020		RX	Yes	Yes
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-002	Apr 7, 2020		RX	Yes	Yes			Y	Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No			Y	Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-002	Apr 7, 2020		RX	Yes	Yes			Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-002	Apr 7, 2020		RX	Yes	Yes			Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No			Y

International Patents for lemborexant

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
Singapore	10202007759R

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Lemborexant

Last updated: July 29, 2025

---

Introduction

Lemborexant, marketed under the brand name Dayvigo, represents a sophisticated advancement in the pharmacotherapy landscape for insomnia. Approved by the U.S. Food and Drug Administration (FDA) in December 2019, this dual orexin receptor antagonist (DORA) has positioned itself as a novel solution amid a burgeoning sleep disorder market. Analyzing its market dynamics and projected financial trajectory involves examining the drug’s clinical profile, competitive landscape, regulatory positioning, and broader industry factors influencing growth.

---

Clinical Profile and Therapeutic Niche

Lemborexant functions by selectively antagonizing orexin receptors, crucial regulators of wakefulness, thereby facilitating the onset and maintenance of sleep. Its mechanism offers advantages over traditional sedative-hypnotics, including a lower risk of dependence and reduced next-day cognitive impairment. These features align with the increasing demand for safer, non-benzodiazepine sleep aids, particularly among aging populations and patients with comorbid conditions.

Clinical trials have demonstrated lemborexant’s superior efficacy in reducing sleep onset latency and improving sleep maintenance compared to placebo, with a favorable safety profile. Such attributes bolster its potential for broad adoption in clinical practice.

---

Market Size and Growth Drivers

The global sleep aids market was valued at approximately USD 6.4 billion in 2021 and is projected to reach USD 10.2 billion by 2027, exhibiting a compound annual growth rate (CAGR) of around 8%. Insomnia affects an estimated 10-30% of adults worldwide, with prevalence rising concomitant with aging demographics and increased stress levels, sectors significantly impacting lemborexant’s potential market share.

Key growth drivers include:

• Demographic Shifts: The rising elderly population, more susceptible to insomnia, directly expands the potential user base.

• Regulatory Preference for Safer Drugs: Evolving guidelines favor drugs with improved safety profiles, favoring lemborexant’s profile over traditional hypnotics.

• Increasing Awareness: Growing consciousness about sleep health enhances demand for effective therapies.

• COVID-19 Pandemic Impact: The pandemic has exacerbated sleep disturbances, temporarily inflating demand for sleep aids.

---

Competitive Landscape

Lemborexant's primary competitors include:

• Suvorexant (Belsomra): A first-generation DORA approved in 2014; has a well-established presence but faces challenges related to safety concerns such as sleep paralysis and next-day residual effects.

• Zolpidem (Ambien): A widely used non-benzodiazepine hypnotic with extensive insurance coverage but associated with dependence risks and sleep-related behaviors.

• Eszopiclone (Lunesta): Offers sustained efficacy; however, concerns about tolerance and dependence persist.

• Ramelteon (Rozerem): Melatonin receptor agonist with minimal abuse potential but comparatively limited efficacy.

Lemborexant’s differentiators—strong efficacy, favorable safety profile, and improved sleep maintenance—position it as a potentially superior choice, especially among patients contraindicated for traditional hypnotics.

---

Regulatory and Reimbursement Dynamics

Post-approval, market success depends on reimbursement environments and physician acceptance. In the U.S., Dayvigo received designation for insurance coverage; however, formulary placement and prior authorization impacts sales velocity. Expanding into other markets hinges on successful regulatory approvals, which are underway or achieved in countries like Japan and the European Union.

In Europe, regulatory review is ongoing, with potential approval anticipated. In emerging markets, local regulatory hurdles and price sensitivity may influence market entry strategies.

---

Financial Trajectory and Revenue Projections

Initial post-market sales in the United States were modest but showed promising growth trajectories, with early data indicating rising prescriptions among sleep specialists and primary care providers. Leading pharmaceutical companies anticipate the following factors to influence lemborexant’s financial performance:

• Market Penetration Rate: Early adoption figures suggest a gradual but steady increase. As awareness and formulary access improve, sales are expected to accelerate.

• Pricing Strategy: The drug's premium positioning, owing to its clinical profile, supports higher price points compared to older sleep medications. Premium pricing, coupled with volume growth, will be essential to revenue targets.

• Pricing and Reimbursement Trends: Favorable reimbursement and payer coverage will directly influence sales growth; unfavorable shifts could constrain revenue.

• Geographical Expansion: International approvals and market penetration will significantly augment the revenue pool. Expansion strategies in Europe and Asia are pivotal to long-term growth.

• Competitive Pressures: The effectiveness of competing therapies may influence market share and pricing autonomy.

Industry analysts estimate that lemborexant could generate billions in annual sales within the next 5–7 years if positioned effectively. For example, leveraging the worldwide sleep aid market CAGR of 8%, combined with its unique positioning, global sales could reach USD 1–2 billion annually by 2030, contingent on market penetration and formulary adoption.

---

Risks and Challenges

Factors tempering optimism include:

• Market Saturation: In mature markets, the growth ceiling is inherently limited.

• Pricing and Reimbursement Barriers: Payer reluctance to cover premium-priced drugs could hamper sales.

• Physician and Patient Acceptance: Habitual prescribing patterns and patient preferences may slow transition from established therapies.

• Competitive Innovation: Pending pipeline drugs with novel mechanisms could erode lemborexant's market share.

• Regulatory Delays: Non-approval in target markets or additional safety concerns could impede international expansion.

---

Emerging Trends and Future Outlook

Innovations in sleep disorder pharmacotherapy are ongoing, with potential for combination therapies and personalized medicine approaches. Lemborexant’s pharmacoeconomic advantages make it a candidate for inclusion in combination regimens targeting complex sleep disorders, further expanding its market.

Furthermore, as precision medicine evolves, identifying patient phenotypes responsive to orexin antagonism may improve treatment outcomes and justify premium pricing, enhancing profitability.

---

Key Takeaways

• Lemborexant’s unique mechanism and safety profile position it favorably within the growing sleep aid market, particularly among older adults and safety-conscious prescribers.

• Market growth is driven by demographic shifts, increased sleep disorder prevalence during global crises, and regulatory trends favoring safer pharmacotherapies.

• International expansion is critical, with regulatory approvals in Europe and Asia poised to significantly boost revenue.

• Competitive dynamics favor lemborexant’s differentiated efficacy; however, pricing, reimbursement, and physician adoption remain pivotal.

• Realization of its full financial potential depends on strategic market access, aggressive commercialization, and ongoing clinical positioning.

---

FAQs

1. What distinguishes lemborexant from other sleep aids?
   Its dual orexin receptor antagonism offers enhanced sleep maintenance with a lower risk profile, including minimal next-day residual effects and dependence potential.

2. What are the primary challenges facing lemborexant’s market growth?
   Challenges include payer reimbursement hurdles, competition from established therapies, limited international approvals, and physician prescribing inertia.

3. How significant is the global market for lemborexant?
   The sleep aid market is projected to reach approximately USD 10 billion by 2027, with lemborexant potentially capturing a sizable segment due to its differentiated profile.

4. What regulatory steps are necessary for global expansion?
   Approval from agencies such as the EMA in Europe and regulatory authorities in Asia, coupled with market-specific pricing and reimbursement negotiations, are essential.

5. Is lemborexant likely to replace traditional hypnotics?
   Its safety profile and efficacy make it a strong alternative; however, widespread replacement depends on prescriber confidence, cost-effectiveness, and patient acceptance.

---

References

[1] MarketWatch, "Sleep Aid Market Size, Share & Trends" (2022).
[2] FDA, "Approval Details for Lemborexant" (2019).
[3] ResearchAndMarkets, "Global Sleep Aids Market Forecast 2021-2027" (2021).
[4] ClinicalTrials.gov, "Lemborexant Efficacy Studies" (2020).
[5] Datamonitor Healthcare, "Insomnia and Sleep Aid Drug Market Analysis" (2022).

---

This analysis aims to equip business professionals with a comprehensive understanding of lemborexant’s market potential and financial outlook, facilitating informed investment and strategic decisions.