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.

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

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

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

International Patents for suvorexant

Country	Patent Number	Title	Estimated Expiration
South Korea	20150014940	SOLID DOSAGE FORMULATIONS OF AN OREXIN RECEPTOR ANTAGONIST
Mexico	368859	FORMULACIONES DE DOSIS SOLIDA DE UN ANTAGONISTA DEL RECEPTOR DE OREXINA. (SOLID DOSAGE FORMULATIONS OF AN OREXIN RECEPTOR ANTAGONIST.)
Peru	20081229	ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAM SUSTITUIDO
Russian Federation	2019126797	СОСТАВЫ ТВЕРДЫХ ДОЗИРОВАННЫХ ЛЕКАРСТВЕННЫХ ФОРМ АНТАГОНИСТА ОРЕКСИНОВОГО РЕЦЕПТОРА
Canada	2670892
Taiwan	200831494	Substituted diazepan orexin receptor antagonists

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Suvorexant

Last updated: July 27, 2025

Introduction

Suvorexant, marketed under the brand name Belsomra, is a prescription medication developed by Eisai Inc. and registered by Merck & Co. for the treatment of insomnia characterized by difficulties with sleep initiation and maintenance. Approved by the U.S. Food and Drug Administration (FDA) in August 2014, suvorexant marks a significant entry into the insomnia therapeutic market, leveraging a novel mechanism of action targeting orexin receptors. As the insomnia market expands driven by increasing prevalence and aging populations, understanding suvorexant’s market dynamics and financial trajectory provides critical insights for stakeholders.

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Market Overview

The global insomnia treatment market is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% through 2027. The rising prevalence of insomnia, attributed to lifestyle factors, mental health issues, and aging demographics, has elevated demand for effective pharmacological options. The cumulative market value is estimated to reach $5-7 billion by the late 2020s, with dominant players including benzodiazepine receptor agonists, melatonin receptor agonists, alpha-adrenergic agonists, and orexin receptor antagonists like suvorexant.

Suvorexant occupies a niche as a selective orexin receptor antagonist (ORA), providing a distinct mechanistic approach compared to traditional hypnotics. This has positioned it as an alternative for patients seeking potentially fewer side effects, such as dependency and next-day impairment, common in benzodiazepines.

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Market Penetration and Competitive Landscape

Despite being a first-in-class drug, suvorexant’s market penetration remains moderate. Key factors influencing its commercial success include:

• Pricing and Reimbursement: Initial pricing positioned suvorexant as a premium insomnia medication, with reimbursement challenges impacting broader adoption.
• Side-Effect Profile: While generally well-tolerated, reports of somnolence, impairment, and complex sleep-related behaviors hindered wider acceptance.
• Prescriber Familiarity: Established prescribing habits favor older medicines; educational efforts are ongoing to promote orexin antagonists.
• Competing Agents: The market also includes non-benzodiazepine hypnotics like zolpidem, eszopiclone, and newer agents such as lemborexant, a rival orexin antagonist approved in 2019.

The rise of lemborexant, a direct competitor approved for similar indications, has intensified competition. Nonetheless, suvorexant maintains a crucial share owing to its first-mover advantage and extensive clinical data.

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Regulatory and Market Dynamics

Regulatory bodies have supported suvorexant’s positioning, emphasizing its safety profile. However, label restrictions—such as contraindications in narcolepsy and cautions regarding complex sleep behaviors—affect prescribing patterns.

Market dynamics are also shaped by non-pharmacological interventions gaining traction, including cognitive-behavioral therapy for insomnia (CBT-I), which limits the growth potential for pharmaceuticals. Nonetheless, pharmacotherapy remains essential, especially for severe cases.

Emerging global markets, particularly in Europe, Asia, and Latin America, present substantial growth opportunities. Regulatory approval processes in these regions are ongoing, and local pricing strategies influence market share.

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Financial Trajectory

Revenue Trends:
Suvorexant’s sales trajectory reflects initial slow uptake post-approval, followed by gradual growth as prescriber awareness increased. In the U.S., annual revenues peaked around $300-400 million in the late 2010s, with some decline subsequently due to intensified competition and generic threats for other sleep medications.

Market Challenges:
Patent expiries, particularly if generic versions emerge, threaten pricing power and revenue streams. Although suvorexant’s primary patent expired in 2021, some secondary patents and exclusivity provisions may extend market protection until the mid-2020s.

Growth Drivers:

• Expansion into emerging markets with growing healthcare infrastructure.
• Development of fixed-dose combination therapies targeting comorbid insomnia and psychiatric disorders.
• Incorporation into personalized medicine strategies, leveraging pharmacogenomic data.

Innovations and Pipeline Development:
Research into next-generation orexin antagonists with improved tolerability or extended-release formulations (e.g., lemborexant’s once-nightly dosing) could redefine competition and market boundaries. Eisai’s efforts in pipeline development, including potential label expansions, can influence future revenues.

Financial Outlook:
Based on current trends and market drivers, suvorexant’s global sales are expected to plateau over the next 3-5 years, assuming patent protections hold and no disruptive innovations occur. However, long-term growth prospects hinge on expanding indications, optimizing pricing strategies, and capturing additional markets.

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Key Market Factors Influencing Future Trajectory

• Regulatory landscape: Stringent approval norms and evolving safety requirements may limit or expand indications.
• Competitive innovations: Emergence of next-generation agents with superior efficacy and safety profiles.
• Healthcare provider acceptance: Increased educational initiatives to boost prescriber confidence in orexin antagonists.
• Market penetration strategies: Pricing, insurance coverage, and patient access programs.
• Broader sleep disorder market growth: Incorporation into personalized and combination therapies.

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Conclusion

Suvorexant’s market dynamics reflect a complex interplay of clinical innovation, competitive pressures, and evolving treatment paradigms in insomnia management. While initial growth faced challenges from established sedative-hypnotics, ongoing adoption, global expansion, and pipeline innovations could stabilize and gradually increase sales. The drug’s financial trajectory will depend heavily on patent life, market acceptance, and the pace of emerging alternatives.

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Key Takeaways

• Innovative Mechanism: Suvorexant’s unique orexin receptor antagonism offers a distinct therapeutic option in insomnia, aligning with evolving preferences for safer hypnotics.
• Moderate Market Penetration: Despite its first-in-class status, suvorexant faces slow uptake due to competition and safety considerations.
• Revenue Outlook: Sales are expected to plateau short-term, with long-term growth contingent upon global expansion and new indications.
• Competitive Landscape: The entry of similar agents like lemborexant intensifies competition, emphasizing differentiated marketing and positioning strategies.
• Growth Opportunities: Emerging markets and pipeline developments present avenues for sustained future revenue streams.

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Frequently Asked Questions (FAQs)

1. What distinguishes suvorexant from other sleep aids?
Suvorexant operates as an orexin receptor antagonist, targeting neuropeptides involved in wakefulness, which differs from GABA-enhancing benzodiazepines and Z-drugs that induce sedation through different pathways, potentially reducing dependency risk.

2. How does patent life impact suvorexant’s financial trajectory?
Primarily protected until 2021, patent expirations open opportunities for generics, threatening revenue streams unless extended through secondary patents or new formulations.

3. What are the primary challenges for suvorexant’s market expansion?
Pricing and reimbursement hurdles, competition from newer agents, safety concerns about complex sleep behaviors, and competition from non-pharmacological therapies limit rapid growth.

4. Which markets hold the most promise for suvorexant’s future sales?
Emerging markets like China, India, and parts of Europe present significant growth potential due to increasing insomnia prevalence and growing healthcare infrastructure.

5. How is the competitive landscape shaping up for suvorexant?
Lemorexant, approved in 2019, presents direct competition, along with ongoing research into next-generation orexin antagonists and other novel insomnia therapies, compelling suvorexant to innovate and adapt.

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References

1. FDA. (2014). FDA approves Belsomra for insomnia.
2. Market Research Future. (2022). Insomnia treatment market analysis.
3. Eisai Inc. Reports. (2021). Financial performance and pipeline updates.
4. IQVIA. (2022). Global sleep disorder therapeutics market trends.
5. European Medicines Agency. (2022). Regulatory updates on orexin antagonists.