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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-three patent family members in thirty-two 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:	53
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	7
Patent Applications:	36
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

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
Eisai Inc.	Phase 2
Brendan Lucey	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.

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			Y	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
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

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
Israel	251759	תכשירים ושיטות לטיפול בנדודי שינה (Compositions and methods for treating insomnia)
Hong Kong	1184454	環丙烷化合物 (CYCLOPROPANE COMPOUND)
World Intellectual Property Organization (WIPO)	2012039371
Australia	2011304285	Cyclopropane compound
Morocco	34609	COMPOSÉ DE CYCLOPROPANE
China	103153963	Cyclopropane compound

DAYVIGO Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for DAYVIGO

Introduction to DAYVIGO

DAYVIGO, developed by Eisai, is a dual orexin receptor antagonist (DORA) known by its generic name, lemborexant. It is one of the key players in the insomnia treatment market, offering a new mechanism of action that differentiates it from traditional hypnotics.

Market Position and Competitors

DAYVIGO operates in a competitive landscape alongside other DORAs such as Merck’s Belsomra (suvorexant) and Idorsia’s Quviviq (daridorexant). Since its launch in 2020, DAYVIGO has been gaining traction, although it still trails behind Belsomra in terms of sales. For instance, in fiscal 2021, DAYVIGO generated $67 million in sales, and by the first three quarters of the following fiscal year, it had brought in around $86 million[3].

Market Growth and Projections

The insomnia market, where DAYVIGO is a significant player, is expected to grow at a compound annual growth rate (CAGR) of 2.6% from $3.2 billion in 2022 to $4.1 billion in 2032 across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan)[1][4].

Role of DORAs in Market Growth

DORAs, including DAYVIGO, are driving this growth. These drugs have been stealing patient share from traditional hypnotics such as Z-drugs, benzodiazepines, and low-dose sedating antidepressants. The sales growth of DORAs is projected to continue at a CAGR of 8.6% to 2032, with DAYVIGO being a key contributor to this trend[1][4].

Financial Performance of DAYVIGO

In terms of financial performance, DAYVIGO has shown steady growth. In 2021, it generated $67 million in sales, and by the first three quarters of the following fiscal year, it had brought in around $86 million. This growth is part of Eisai’s overall stable revenue profile, which has seen a modest increase in gross profit and a significant rise in operating profit due to cost reduction and product mix improvements[5].

Challenges and Opportunities

Despite the positive growth trajectory, the insomnia market, including DAYVIGO, faces several challenges. One major obstacle is the loss of market exclusivity. DAYVIGO is set to lose its market exclusivity in the US in 2031, which will allow cheaper generic versions to enter the market, potentially eroding sales for the brand[1][4].

However, the introduction of new pipeline products and the continued uptake of DORAs are expected to fuel market growth. For example, four late-stage pipeline products, including Vanda Pharmaceuticals’ Hetlioz, EUSOL’s SM-1, Taisho Pharmaceutical’s vornorexant, and Imbrium Therapeutics’ sunobinop, are forecast to contribute $330.2 million in sales by 2032[1][4].

Regional Dominance

The US represents the largest market for insomnia treatments, accounting for 81.9% of the sales in the 7MM by 2032. DAYVIGO, along with other DORAs, is expected to benefit from this dominance, especially since some of the new pipeline products are forecast to launch exclusively in the US[1][4].

Clinical Efficacy and Differentiation

DAYVIGO has demonstrated significant clinical efficacy in improving sleep onset, sleep maintenance, and total sleep time, while also reducing daytime sleepiness. This differentiation is crucial in a market where patient outcomes are increasingly important. As Patty Torr, US president and general manager of Idorsia, notes, "Sleep is about restoring your body—all that happens when you’re sleeping; but how you feel the next day is also important"[3].

Future Outlook

Eisai’s strategic focus on DAYVIGO, along with its other products like LEQEMBI for Alzheimer's disease, indicates a commitment to driving revenue growth through innovative treatments. The company’s plans to expand its sales force and implement comprehensive marketing strategies further support the potential for DAYVIGO to maintain its market presence and continue growing[5].

Key Takeaways

• Market Growth: The insomnia market is expected to grow at a CAGR of 2.6% to 2032, driven by DORAs like DAYVIGO.
• Financial Performance: DAYVIGO has shown steady sales growth, contributing to Eisai’s overall stable revenue.
• Challenges: Loss of market exclusivity in 2031 could lead to sales erosion due to generic competition.
• Opportunities: New pipeline products and continued DORA uptake will fuel market growth.
• Regional Dominance: The US is the largest market for insomnia treatments, benefiting DAYVIGO and other DORAs.
• Clinical Efficacy: DAYVIGO has demonstrated significant improvements in sleep parameters and reduced daytime sleepiness.

FAQs

Q: What is DAYVIGO, and how does it treat insomnia? A: DAYVIGO, or lemborexant, is a dual orexin receptor antagonist (DORA) that treats insomnia by targeting the orexin system, which regulates sleep and wakefulness.

Q: How does DAYVIGO compare to other DORAs in the market? A: DAYVIGO competes with other DORAs like Belsomra (suvorexant) and Quviviq (daridorexant). While it trails behind Belsomra in sales, it has shown significant clinical efficacy and is gaining market share.

Q: What are the projected sales for DAYVIGO and the overall insomnia market by 2032? A: The insomnia market is expected to grow to $4.1 billion by 2032, with DORAs like DAYVIGO driving this growth at a CAGR of 8.6%.

Q: What challenges does DAYVIGO face in the market? A: DAYVIGO faces the challenge of losing market exclusivity in the US in 2031, which could lead to cheaper generic versions entering the market and eroding sales.

Q: How does Eisai plan to support the growth of DAYVIGO? A: Eisai plans to support DAYVIGO through cost reduction, product mix improvements, and strategic marketing and sales force expansion, similar to its approach with other successful products like LEQEMBI.

Sources

1. European Pharmaceutical Review: Market outlook to 2032: future trends across the seven major markets.
2. SHIONOGI & CO., LTD.: Financial results briefing for Q2 of FY2024.
3. Pharmaceutical Executive: A Sleeping Giant?: Quviviq.
4. Clinical Trials Arena: Dual orexin receptor antagonists to drive insomnia market across 7MM.
5. Investing.com: Earnings call: Eisai Co. Ltd. maintains steady revenue with a focus on Alzheimer's treatment.