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:	27
Patent Applications:	24
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
Nova Scotia Health Authority	Phase 4
Brendan Lucey	Phase 2
Chulalongkorn University	Phase 1/Phase 2

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

International Patents for lemborexant

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2012039371
Brazil	112017007063	?composições e métodos para o tratamento de insônia?
Croatia	P20150657
Mexico	376164	COMPOSICIONES Y METODOS PARA TRATAR EL INSOMNIO. (COMPOSITIONS AND METHODS FOR TREATING INSOMNIA)
Japan	6659681

Market Dynamics and Financial Trajectory for Lemborexant (Dayvigo)

Introduction

Lemborexant, marketed as Dayvigo, is a dual orexin receptor antagonist (DORA) developed by Eisai Co., Ltd. for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults. Here, we delve into the market dynamics and financial trajectory of this drug.

Mechanism of Action and Clinical Trials

Lemborexant works by antagonizing the orexin receptors OX1R and OX2R, which are involved in the regulation of wakefulness. This mechanism is distinct from traditional sleep aids and offers a new approach to treating insomnia[2].

Key clinical trials, such as SUNRISE 1 and SUNRISE 2, have demonstrated the efficacy and safety of lemborexant. SUNRISE 2, a 12-month global Phase III study, showed statistically significant improvements in sleep onset latency, sleep efficiency, and wake after sleep onset compared to placebo and active comparators like zolpidem ER[2][4].

Market Entry and Approval

Lemborexant was approved by the U.S. FDA in December 2019 for the treatment of insomnia in adults. The drug is available in 5 mg and 10 mg oral tablets, with the recommended dose being 5 mg once daily, adjustable to a maximum of 10 mg based on clinical response and tolerability[2].

Market Outlook

The insomnia market, where lemborexant operates, is anticipated to grow at a compound annual growth rate (CAGR) of 2.6% from $3.2 billion in 2022 to $4.1 billion in 2032. This growth is driven by an increase in the patient share of DORAs, with lemborexant being a key player[3].

Dominance of the US Market

The US represents the largest insomnia market, accounting for 81.9% of sales expected in 2032 within the seven major markets. This dominance is due to the larger insomnia population and higher drug prices in the US[3].

Competitive Landscape

Lemborexant enters a market where other DORAs, such as suvorexant (Belsomra), are already present. However, lemborexant's profile, with fewer side effects and significant improvements in sleep parameters, positions it as a future growth driver in the insomnia market[4].

Comparison with Other Treatments

Pharmacoeconomic analyses have compared lemborexant with other insomnia treatments. For instance, the Canadian Agency for Drugs and Technologies in Health (CADTH) found that lemborexant had a high incremental cost-effectiveness ratio (ICER) compared to trazodone, suggesting that lemborexant would need a significant price reduction to be cost-effective relative to other active comparators[1].

Financial Projections

Sales Forecast

Bloomberg estimates suggest that lemborexant sales for the 12 months ending March 31, 2023, were approximately JPY36,900 million (USD329 million). This indicates a strong initial market performance for the drug[4].

Pricing and Cost-Effectiveness

The 30-day cost of lemborexant is $45.59, significantly higher than many of its comparators, which range from $1.26 to $15.31. For lemborexant to be costed similarly to other active comparators, its price would need to be reduced by 76% to 82% according to CADTH's reanalysis[1].

Challenges and Opportunities

Patent Exclusivity and Generic Competition

Lemborexant is set to lose market exclusivity in the US in 2031, which will allow cheaper generic versions of DORAs to enter the market. This could result in sales erosion for branded products but also drive overall market growth as more patients access DORA treatments[3].

Regulatory and Clinical Hurdles

The comparative clinical evidence for lemborexant is limited, particularly against some active comparators. This uncertainty affects the firm conclusions about its comparative efficacy and cost-effectiveness. However, ongoing and future studies may address these gaps and further solidify lemborexant's position in the market[1][2].

Future Trends and Growth Drivers

Increasing Prevalence and Awareness

The growing prevalence and awareness of insomnia, coupled with unmet needs in its treatment, present a commercial opportunity for lemborexant. As more patients seek effective treatments, the demand for insomnia therapeutics, including DORAs, is expected to rise[4].

Pipeline Products and Market Expansion

The launch of other pipeline products in the insomnia market, such as vornorexant and sunobinop, will contribute to market growth. These new entries, along with the increased uptake of DORAs, will fuel the insomnia market's expansion[3].

Key Takeaways

• Lemborexant is a dual orexin receptor antagonist approved for treating insomnia in adults.
• The drug has shown significant improvements in sleep onset latency and maintenance in clinical trials.
• The insomnia market is expected to grow, driven by the increasing patient share of DORAs.
• Lemborexant faces competition from other DORAs but has a strong initial market performance.
• Pricing and cost-effectiveness remain critical factors, with potential price reductions needed for broader adoption.
• The loss of patent exclusivity and entry of generics will impact sales but drive overall market growth.

FAQs

Q: What is the mechanism of action of lemborexant?

A: Lemborexant works by antagonizing the orexin receptors OX1R and OX2R, which are involved in the regulation of wakefulness.

Q: What are the key clinical trials that have evaluated lemborexant?

A: The key clinical trials include SUNRISE 1 and SUNRISE 2, which demonstrated the efficacy and safety of lemborexant in treating insomnia.

Q: When was lemborexant approved by the FDA?

A: Lemborexant was approved by the U.S. FDA in December 2019.

Q: What is the projected market growth for the insomnia market?

A: The insomnia market is anticipated to grow at a CAGR of 2.6% from $3.2 billion in 2022 to $4.1 billion in 2032.

Q: What are the potential challenges for lemborexant in the market?

A: Lemborexant faces challenges such as high pricing, limited comparative clinical evidence, and the upcoming loss of patent exclusivity, which will allow generic competition.

Sources

1. Pharmacoeconomic Review - Lemborexant (Dayvigo) - NCBI
2. U.S. FDA APPROVES EISAI'S DAYVIGO™ (LEMBOREXANT) FOR ...
3. Market outlook to 2032: future trends across the seven major markets
4. Lemborexant On Track For Insomnia Market Entry - Fitch Solutions

Last updated: 2024-12-16