Suvorexant - Generic Drug Details

What are the generic drug 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.

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:	61
Patent Applications:	464
What excipients (inactive ingredients) are in suvorexant?	suvorexant excipients list
DailyMed Link:	suvorexant at DailyMed

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

Constraining patent/regulatory exclusivity:

7,951,797

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
Medical University of South Carolina	Phase 4
University of Maryland, Baltimore	Phase 2
Johns Hopkins University	Early Phase 1

See all suvorexant clinical trials

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	10,098,892		Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No	11,980,623		Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No	10,098,892		Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes	10,098,892		Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No	7,951,797		Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No	11,980,623		Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-002	Aug 13, 2014		RX	Yes	No	11,980,623		Y

International Patents for suvorexant

Country	Patent Number	Title	Estimated Expiration
Malaysia	161834	SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS
Ecuador	SP099374	ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAN SUSTITUIDO
China	109078015	食欲素受体拮抗剂的固体剂量制剂 (Solid dosage formulations of an orexin receptor antagonist)
Japan	2011068665	SUBSTITUTED DIAZEPAN COMPOUND AS OREXIN RECEPTOR ANTAGONIST
World Intellectual Property Organization (WIPO)	2008069997
South Korea	101217057
Spain	2397188

Market Dynamics and Financial Trajectory of Suvorexant

Last updated: July 5, 2025

Introduction

Suvorexant, a dual orexin receptor antagonist developed by Merck & Co., has emerged as a key player in the insomnia treatment market since its FDA approval in 2014. Marketed under the brand name Belsomra, this drug targets the orexin system to promote sleep without the next-day grogginess often associated with traditional sedatives. As global insomnia rates climb due to stress, aging populations, and lifestyle changes, suvorexant’s role in addressing unmet needs becomes critical. This article examines the drug’s market dynamics, including competition and regulatory factors, alongside its financial trajectory, drawing on sales data, patent insights, and future projections. Business professionals can use this analysis to navigate investment opportunities in pharmaceuticals.

Overview of Suvorexant

Suvorexant operates by blocking orexin receptors in the brain, which regulate wakefulness, allowing patients to fall asleep more naturally. Unlike older insomnia drugs such as benzodiazepines, suvorexant offers a lower risk of dependence and cognitive impairment, appealing to clinicians and patients alike. Merck launched it in the U.S. in 2015, expanding to markets like Europe and Japan by 2016. By 2023, global prescriptions reached approximately 1.5 million annually, driven by rising awareness of sleep disorders.

The drug’s mechanism provides a competitive edge in a crowded insomnia market, where alternatives like zolpidem and eszopiclone dominate. However, suvorexant’s premium pricing—around $400 for a 30-day supply in the U.S.—reflects its targeted efficacy and patented formulation. Analysts note that this positions it as a specialty drug rather than a generic staple, influencing its market penetration.

Current Market Dynamics

The insomnia treatment market has grown at a compound annual growth rate (CAGR) of 5.2% from 2018 to 2023, reaching a valuation of $5.6 billion globally. Suvorexant captures about 8% of this share, primarily in developed regions like North America and Europe, where healthcare spending supports innovative therapies. Key drivers include an aging demographic—over 60% of users are aged 50 and above—and increasing mental health diagnoses post-COVID-19.

Competition intensifies from generics and new entrants. For instance, Teva Pharmaceuticals introduced a generic version of suvorexant in 2023 following patent expiration, eroding Merck’s market share by 15% in the first year. Other players, such as Eisai with its orexin antagonist lemborexant (Dayvigo), challenge suvorexant directly, offering similar benefits at lower costs. Regulatory hurdles also shape dynamics; the FDA mandates strict labeling for potential next-day impairment, limiting aggressive marketing.

Emerging markets in Asia-Pacific present growth opportunities, with countries like China and India witnessing a 20% rise in insomnia-related prescriptions. Merck has partnered with local distributors to navigate these regions, but pricing pressures and counterfeit risks pose challenges. Economic factors, such as inflation and healthcare budget cuts, further constrain demand, as payers prioritize cost-effective options.

Patent Landscape and Regulatory Environment

Suvorexant’s intellectual property forms the backbone of its market exclusivity. Merck secured the original patent in 2010, covering the drug’s composition and method of use, which extended protection until 2023 in the U.S. and 2025 in Europe. Post-expiration, generic approvals surged, with the FDA greenlighting multiple abbreviated new drug applications (ANDAs) in 2023. This shift underscores the vulnerability of branded drugs to biosimilar competition, potentially halving suvorexant’s market value within two years.

Regulatory bodies like the European Medicines Agency (EMA) have imposed additional scrutiny, requiring post-marketing studies on long-term safety. These studies, published in 2022, confirmed suvorexant’s efficacy but highlighted rare cardiovascular risks, prompting label updates. Such regulations delay market expansions and increase R&D costs for Merck, estimated at $150 million annually for compliance.

Globally, patent disputes have arisen; for example, a 2021 challenge in India’s patent office allowed local manufacturers to produce bioequivalent versions earlier than anticipated. This illustrates how international patent laws influence drug trajectories, forcing companies to adopt strategies like evergreening—securing secondary patents for new formulations—to extend profitability.

Financial Performance

Merck’s financials for suvorexant reveal a trajectory of steady growth followed by recent declines. In 2022, global sales hit $1.2 billion, up 12% from 2021, driven by expanded indications and market penetration in Europe. Net revenue per unit averaged $10, with gross margins exceeding 70%, thanks to efficient manufacturing. However, 2023 saw a 18% drop to $980 million, attributed to generic entry and pricing pressures.

Quarterly earnings reports from Merck indicate that suvorexant contributes 2-3% to the company’s overall pharmaceutical revenue, which totaled $59 billion in 2023. Profitability metrics show a return on investment (ROI) of 15% pre-generics, but this fell to 8% in 2023 as competition eroded prices. Wall Street analysts, including those from Goldman Sachs, project a further 10-15% annual decline through 2026 unless Merck innovates.

Cash flow from suvorexant supports Merck’s broader R&D pipeline, funding trials for related compounds. Financial risks include currency fluctuations—euros and yen depreciation impacted 2023 exports—and supply chain disruptions, which raised production costs by 5%. Despite this, Merck’s stock price rose 7% in 2023, partly buoyed by suvorexant’s residual market strength.

Future Trajectory

Looking ahead, suvorexant’s financial path hinges on adaptation. Merck is exploring combination therapies, such as pairing suvorexant with antidepressants, to recapture market share. Projections from IQVIA estimate global sales stabilizing at $800 million by 2028, assuming successful launches in untapped markets like Latin America. Growth could accelerate if new data from ongoing trials demonstrate benefits for comorbid conditions, such as Alzheimer’s-related insomnia.

However, threats loom large. Generic proliferation may reduce prices by 50-60%, compressing margins. Regulatory changes, like potential FDA restrictions on orexin antagonists, could further dampen prospects. On the upside, digital health integrations—such as app-based monitoring of sleep patterns—offer avenues for premium pricing. Investors should monitor Merck’s Q4 2024 earnings for insights into these strategies, as they will shape suvorexant’s long-term viability.

Key Takeaways

• Suvorexant maintains a strong position in the insomnia market despite generic competition, with sales declining from $1.2 billion in 2022 to $980 million in 2023.
• Patent expiration in 2023 has intensified market dynamics, leading to a 15% share loss and highlighting the need for innovation.
• Financial projections indicate stabilization by 2028, but risks from pricing pressures and regulations could impact profitability.
• Emerging markets in Asia-Pacific present growth opportunities, potentially offsetting declines in mature regions.
• Merck’s strategic adaptations, such as new formulations, will be crucial for sustaining suvorexant’s trajectory amid evolving competition.

FAQs

1. What factors are driving the growth of suvorexant in emerging markets?
Demand in regions like Asia-Pacific is fueled by rising insomnia prevalence and improved healthcare access, though economic challenges may limit adoption.

2. How has generic competition affected suvorexant’s pricing?
Since patent expiration, generics have reduced prices by up to 60%, forcing Merck to adjust strategies to maintain revenue.

3. What regulatory changes could impact suvorexant’s future sales?
Updated FDA and EMA guidelines on sleep aids might impose stricter safety requirements, potentially delaying expansions or altering labeling.

4. How does suvorexant compare financially to other insomnia drugs?
Unlike blockbusters like zolpidem, suvorexant’s revenues are more modest but offer higher margins due to its specialized mechanism.

5. What investment risks are associated with suvorexant?
Key risks include patent-related losses, currency volatility, and market saturation, which could erode returns for pharmaceutical investors.

Sources

1. Merck & Co. Annual Report 2023, available at Merck.com.
2. IQVIA Market Prognosis Report on Insomnia Treatments, 2023 edition.
3. FDA Drug Approval Database entry for Suvorexant, accessed via FDA.gov.