BELSOMRA Drug Patent Profile

When do Belsomra patents expire, and when can generic versions of Belsomra launch?

Belsomra is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in BELSOMRA is suvorexant. One supplier is listed for this compound. Additional details are available on the suvorexant profile page.

DrugPatentWatch^® Generic Entry Outlook for Belsomra

Belsomra was eligible for patent challenges on August 13, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 20, 2029. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for BELSOMRA

International Patents:	75
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	35
Clinical Trials:	34
Patent Applications:	495
Drug Prices:	Drug price information for BELSOMRA
What excipients (inactive ingredients) are in BELSOMRA?	BELSOMRA excipients list
DailyMed Link:	BELSOMRA at DailyMed

See drug prices for BELSOMRA

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

NDA:

204569

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 BELSOMRA

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

Sponsor	Phase
Massachusetts Institute of Technology	PHASE4
Massachusetts General Hospital	PHASE4
Merck Sharp & Dohme LLC	Phase 2

See all BELSOMRA clinical trials

Pharmacology for BELSOMRA

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

Paragraph IV (Patent) Challenges for BELSOMRA

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 BELSOMRA

BELSOMRA is protected by three US patents.

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
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	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

International Patents for BELSOMRA

When does loss-of-exclusivity occur for BELSOMRA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

European Patent Office

Honduras

Hong Kong

Japan

Malaysia

Mexico

Morocco

New Zealand

Nicaragua

Norway

Peru

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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 BELSOMRA around the world.

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

Market Dynamics and Financial Trajectory for BELSOMRA (Suvorexant)

Last updated: July 27, 2025

Introduction

BELSOMRA (suvorexant) is a prescription medication developed by Eisai Co., Ltd. and marketed by US-based brands such as Merck in the United States. Approved by the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of insomnia characterized by difficulty with sleep onset and maintenance, BELSOMRA’s commercial trajectory offers a poignant case study in the evolving landscape of sleep disorder therapeutics. This analysis dissects the market dynamics influencing BELSOMRA’s growth strategy and delineates its financial trajectory within the broader pharmaceutical ecosystem of sleep aids.

Market Landscape for Insomnia Medications

The global sleep aids market is projected to reach USD 7.8 billion by 2027, driven by increasing prevalence of sleep disorders, lifestyle stressors, and an aging population. The existing competitive landscape comprises benzodiazepines, non-benzodiazepine receptor agonists (e.g., zolpidem, eszopiclone), melatonin receptor agonists (e.g.,ramelteon), and orexin receptor antagonists like BELSOMRA.

Despite the popularity of sedative hypnotics, concerns over dependency, residual sedation, and adverse effects prompted demand for novel, safer options like BELSOMRA. Its unique mechanism, targeting orexin neuropeptides — regulators of wakefulness — positions it differently than traditional agents.

Market Dynamics Influencing BELSOMRA

1. Market Penetration and Adoption Challenges

Following its 2014 launch, BELSOMRA gained initial traction primarily among patients intolerant to benzodiazepines or seeking non-habit-forming options. However, uptake has been tempered by factors such as:

• Pricing and Reimbursement: BELSOMRA’s premium pricing and variable insurance coverage influenced prescriber and patient access.
• Limited Awareness and Physician Preference: Despite clinical benefits, familiarity with orexin antagonists remains niche compared to established sedative hypnotics.
• Side Effect Profile: Reports of next-day somnolence and rare adverse events prompted cautious prescribing.

2. Competitive Pressure from Established and Emerging Therapies

The market features entrenched players such as zolpidem and eszopiclone, which benefit from brand recognition, extensive formulary coverage, and extensive data sets. Recently, the introduction of other orexin receptor antagonists like Lunesta (suvorexant formulations) and novel agents like lemborexant (Dayvigo) compounds competitive pressures.

The drug's positioning as a sleep aid with a potentially reduced dependence profile has driven niche adoption; nonetheless, fierce competition has constrained rapid growth.

3. Regulatory and Geographical Dynamics

While FDA approval established BELSOMRA’s footprint in the U.S., regulatory landscapes in Europe, Asia, and emerging markets have been more cautious. European Medicines Agency (EMA) approval faced delays, and regional safety concerns delayed broader commercialization. Regional pharmacovigilance may impact BELSOMRA's global expansion.

4. Evolving Market Preferences and Patient Demand

The increasing demand for non-addictive sleep medications has heightened interest in orexin antagonists. Real-world evidence points toward improved safety profiles, thus positively impacting BELSOMRA’s adoption among specific patient populations and physicians prioritizing safety.

5. Patent Life and Patent Expiry Risks

Patent protection for BELSOMRA is set to expire in major markets by 2025-2027, exposing it to generic competition. The impending patent cliff can erode market share unless paired with lifecycle management strategies such as formulation enhancements or expanded indications.

Financial Trajectory of BELSOMRA

1. Revenue Growth Trends

Initial sales post-launch were modest, with U.S. 2015 sales estimated at approximately USD 100 million. As awareness increased and prescriber confidence grew, sales volumes escalated gradually, reaching an estimated USD 250-300 million annually in the U.S. by 2021[^1].

Global sales remain limited relative to the size of the sleep aid market, reflecting moderate penetration and the impact of regional regulatory delays.

2. Profitability and Cost Dynamics

Development and commercialization costs for BELSOMRA, including R&D, marketing, and regulatory compliance, have been significant. Given the moderate market share and stiff competition, profit margins are under pressure. The high costs of post-market surveillance for safety further influence the financial profile.

3. Impact of Patents and Competition

The approaching patent expiry threatens revenue streams, possibly leading to revenue declines unless mitigated by strategic interventions such as:

• Lifecycle Management: Development of extended-release formulations or fixed-dose combinations.
• New Indications: Clinical trials exploring off-label uses or comorbid conditions.
• Global Expansion: Accelerating entry into emerging markets with less saturated competition.

4. Strategic Alliances and Licensing

Eisai’s licensing agreements, such as collaboration with Merck, influence BELSOMRA’s distribution strategies and revenue sharing. These partnerships are likely to evolve in response to patent expirations and market demands, impacting sales figures.

Market Outlook and Future Trends

1. Growing Preference for Orexin-Based Sleep Aids

The shift toward orexin receptor antagonists as preferred therapies for chronic insomnia favors BELSOMRA’s long-term prospects, especially if post-market safety and efficacy profiles sustain their reputation.

2. Technological Innovations and Formulation Advances

Development of dual-action formulations, flavor-enhanced tablets, and personalized medicine approaches could improve patient adherence and market penetration.

3. Regulatory Pathways and Market Expansion

Efforts to secure approval in Europe and Asia could diversify revenue streams. Additionally, accelerated approval pathways for new indications, such as sleep-related disorders associated with neurodegenerative diseases, could open new markets.

4. Impact of Generics and Biosimilars

Excluding biosimilars, generic versions of BELSOMRA due to patent expiry can precipitate significant revenue decline, mirroring trends observed with other sleep medications.

Key Takeaways

• Market Positioning: BELSOMRA’s unique mechanism appeals to a niche seeking non-addictive sleep aids; however, entrenched competitors limit widespread adoption.
• Revenue Outlook: While sales have grown steadily, they remain vulnerable to patent expiration, pricing pressures, and regional regulation delays.
• Strategic Opportunities: Expanding geographic reach, developing new formulations, and pursuing additional indications are critical to sustaining financial growth.
• Competitive Landscape: Maintaining differentiation through safety profiles, clinical efficacy, and patient acceptance is essential amid fierce competition.
• Risk Management: Patent expiration and market saturation pose major risks; proactive lifecycle strategies are vital for long-term revenue preservation.

FAQs

1. What distinguishes BELSOMRA from other insomnia medications?
BELSOMRA selectively targets orexin receptors, promoting sleep without the dependence issues associated with benzodiazepines or traditional non-benzodiazepine sedatives.

2. How does patent expiry affect BELSOMRA’s financial outlook?
Patent expiration around 2025-2027 may lead to generic competition, significantly reducing revenue unless complemented by new formulations or indications.

3. Which markets are most promising for BELSOMRA’s growth?
The U.S. remains the primary market, with potential growth in Europe and Asia contingent on regulatory approvals and regional safety assessments.

4. Can BELSOMRA penetrate the competitive sleep aid market further?
Yes, especially by emphasizing safety profiles, expanding indications, and leveraging market trends favoring orexin antagonists.

5. What strategy should Eisai adopt post-patent expiry?
Focus on lifecycle management, new formulations, global expansion, and exploring additional therapeutic indications to offset revenue loss and maintain market relevance.

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References

[1] IQVIA. (2022). U.S. prescription drug sales analysis.
[2] MarketWatch. (2022). Sleep aids market size and growth projections.
[3] FDA. (2014). BELSOMRA prescribing information.
[4] Epocrates. (2022). Insomnia medications overview.