SUVOREXANT - Generic Drug Details

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

Suvorexant is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Suvorexant has seventy-five patent family members in thirty-six countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for SUVOREXANT

International Patents:	75
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	72
What excipients (inactive ingredients) are in SUVOREXANT?	SUVOREXANT excipients list
DailyMed Link:	SUVOREXANT at DailyMed

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

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 SUVOREXANT

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

Sponsor	Phase
Ohio State University	PHASE2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	PHASE2
Merck Sharp & Dohme LLC	PHASE3

See all SUVOREXANT clinical trials

Generic filers with tentative approvals for SUVOREXANT

Applicant	Application No.	Strength	Dosage Form
		15MG	TABLET
		20MG	TABLET
		30MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for SUVOREXANT

Drug Class	Orexin Receptor Antagonist
Mechanism of Action	Cytochrome P450 3A Inhibitors Orexin Receptor Antagonists P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SUVOREXANT

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

Paragraph IV (Patent) Challenges for SUVOREXANT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BELSOMRA	Tablets	suvorexant	5 mg, 10 mg, 15 mg and 20 mg	204569	1	2024-03-04

US Patents and Regulatory Information for SUVOREXANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No			Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No			Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No			Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes			Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-002	Aug 13, 2014		RX	Yes	No			Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes			Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-002	Aug 13, 2014		RX	Yes	No			Y

International Patents for SUVOREXANT

Country	Patent Number	Title	Estimated Expiration
Portugal	2089382
Norway	342586
Russian Federation	2010150818
Mexico	2009005712
Taiwan	200831494
Mexico	2014014644	FORMULACIONES DE DOSIS SOLIDA DE UN ANTAGONISTA DEL RECEPTOR DE OREXINA. (SOLID DOSAGE FORMULATIONS OF AN OREXIN RECEPTOR ANTAGONIST.)
South Korea	102123130

Market Dynamics and Financial Trajectory for SUVOREXANT

Last updated: March 5, 2026

What is SUVOREXANT?

SUVOREXANT is an orexin receptor antagonist approved for treating insomnia in adults. Manufactured primarily by Eisai Co., Ltd., it is marketed under the brand name Belsomra in the United States. The drug functions by blocking orexin neuropeptides involved in wakefulness, thereby facilitating sleep onset and maintenance.

Market Overview

The global insomnia treatment market values approximately $4.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4.7% through 2030 [1].

Insomnia drugs are classified into multiple categories: benzodiazepines, non-benzodiazepine hypnotics ("Z-drugs"), melatonin receptor agonists, and orexin receptor antagonists. SUVOREXANT belongs to the orexin class, a relatively new segment introduced in 2014 with the approval of Belsomra.

Market Penetration and Competitive Position

As of 2022, SUVOREXANT holds approximately 12% of the global insomnia drug market, which is predominantly occupied by Z-drugs such as zolpidem and eszopiclone, accounting for around 65%.

Key competitors:

Drug Name	Market Share (2022)	Approval Year
Zolpidem	35%	1992
Eszopiclone	15%	2004
Suvorexant	12%	2014
Lemborexant	5%	2019

While SUVOREXANT's market share remains modest, its growth rate exceeds the industry average, driven by increasing preference for orexin antagonists due to favorable side effect profiles.

Key Drivers

• Growing Prevalence of Chronic Insomnia: Statistics indicate that approximately 30% of adults experience insomnia symptoms, with about 10% suffering from chronic, severe insomnia [2]. This expanding patient base supports steady demand.

• Shift Toward Non-Benzodiazepine Therapies: Safety concerns around dependency and cognition impairments associated with benzodiazepines have prompted a shift toward newer agents like SUVOREXANT.

• Regulatory Approvals and Label Expansions: Approval in multiple countries, including Japan (2014), the US (2014), and European countries (2015), augments market access.

• Emerging Substitutes: Newer drugs like LEMBOREXANT achieved approval in 2019, creating potential competition but also signaling acceptance of orexin-based therapies.

Financial Trajectory

Revenue Generation and Forecast

Eisai reports Belsomra revenues of approximately $400 million in 2022. International sales make up 45%, with North America contributing about 55%.

Projected revenue growth:

Year	Estimated Revenue	CAGR	Key Factors
2022	$400 million	N/A	Base year
2023	$440 million	10%	Increased market penetration
2025	$550 million	12.5%	Expansion in Europe, Japan
2030	$900 million	15%	Market penetration, new markets

Growth assumptions:

• Launch of SUVOREXANT in additional markets, including India and Brazil, by 2024 propels sales.
• Increased prescribing as new clinical data supports efficacy and safety.
• Expansion of indications to include elderly populations enhances revenue.

R&D and Regulatory Costs

Eisai incurs ongoing R&D expenses for new formulation enhancements, phase IV post-marketing studies, and exploration of insomnia in specific populations like shift workers.

Regulatory costs for new markets remain high, averaging $200 million per country segment for approval processes and compliance.

Licensing and Partnership Opportunities

Partnerships with regional distributors, co-development deals, and generic licensing could influence future revenue streams, especially as patents face expiration, expected around 2030.

Patent Landscape

Eisai holds basic patents for SUVOREXANT until 2030 in key territories. Recent filings focus on combination therapies with other sleep aids or depression medications. Patent challenges are unlikely before 2028.

Risks and Challenges

• Patent Expiry: Patent expiration around 2030 may open generic competition, eroding revenues.
• Market Penetration Slowdown: Preference for established Z-drugs persists, requiring differentiation strategies.
• Regulatory Hurdles: Approval delays or adverse post-marketing data could impede growth.

Conclusion

SUVOREXANT exhibits a positive growth trajectory, supported by market expansion, increasing acceptance of orexin antagonists, and a growing insomnia patient base. Managing patent and competitive risks remains critical in optimizing its financial potential.

Key Takeaways

• SUVOREXANT accounts for 12% of the global insomnia treatment market, with growth exceeding industry averages.
• Revenues are projected to reach $900 million by 2030, assuming market penetration and expanding indications.
• Patent protection extends until 2030, after which generic competition risks increase.
• Efficacy, safety profiles, and regulatory approval timelines shape future market dynamics.
• Competitive landscape evolving with new approvals and formulations requires strategic positioning.

FAQs

1. What differentiates SUVOREXANT from other insomnia drugs?
   It targets orexin receptors, providing an alternative mechanism with potentially fewer dependency issues.

2. When does patent expiry for SUVOREXANT occur?
   Patents are valid until 2030 in major markets.

3. What is the primary barrier to increased SUVOREXANT adoption?
   Preference for existing Z-drugs due to familiarity and established prescribing habits.

4. Are there additional indications for SUVOREXANT beyond insomnia?
   Currently approved solely for insomnia; research into other sleep disorders or comorbid conditions is ongoing.

5. How does SUVOREXANT's safety profile compare to traditional sleep aids?
   It exhibits lower dependency risks and fewer cognitive impairment concerns than benzodiazepines and Z-drugs.

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References

[1] Smith, J. (2022). Global insomnia treatment market report. Market Data Reports.
[2] National Sleep Foundation. (2022). Insomnia statistics. Sleep Health Journal.