BELSOMRA Drug Patent Profile

When do Belsomra patents expire, and what generic alternatives are available?

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

Constraining patent/regulatory exclusivity:

7,951,797

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 General Hospital	PHASE4
Massachusetts Institute of Technology	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.

This potential generic entry date is based on patent 7,951,797.

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	7,951,797		Y	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	204569-002	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	10,098,892		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	204569-001	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

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
Canada	2795550	FORMES PHARMACEUTIQUES POSOLOGIQUES SOLIDES D'UN ANTAGONISTE DES RECEPTEURS DES OREXINES (SOLID DOSAGE FORMULATIONS OF AN OREXIN RECEPTOR ANTAGONIST)
Nicaragua	200900100
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)
New Zealand	577334	SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS
Mexico	368859	FORMULACIONES DE DOSIS SOLIDA DE UN ANTAGONISTA DEL RECEPTOR DE OREXINA. (SOLID DOSAGE FORMULATIONS OF AN OREXIN RECEPTOR ANTAGONIST.)
Colombia	6190524
Japan	2011079848

Market Dynamics and Financial Trajectory for BELSOMRA (Suvorexant)

Last updated: December 25, 2025

Executive Summary

BELSOMRA (suvorexant) is a prescription medication developed by Eszopiclone, marketed primarily as a treatment for adult insomnia characterized by difficulty with sleep onset and maintenance. Since its FDA approval in 2014, BELSOMRA has experienced steady market penetration driven by demographic shifts, regulatory policies, and evolving treatment paradigms. This report explores the key market drivers, competitive landscape, financial trajectories, and future outlook for BELSOMRA, providing stakeholders with a comprehensive view of its commercial potential.

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1. Introduction: Overview of BELSOMRA

Product Profile

• Generic Name: Suvorexant
• Brand Name: BELSOMRA
• Manufacturer: Takeda Pharmaceuticals (originally co-developed with Merck & Co.)
• FDA Approval Date: August 13, 2014
• Indication: Treatment of adult insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Mechanism of Action
BELSOMRA is a dual orexin receptor antagonist (DORA), targeting orexin-A and orexin-B neuropeptides involved in wakefulness regulation, thereby promoting sleep without the typical risks associated with benzodiazepines or Z-drugs.[1]

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2. Market Dynamics

2.1. Key Drivers

Driver Category	Details	Impact
Demographic Trends	Aging populations, especially in the US and Europe, increase insomnia prevalence.[2]	Expands potential user base
Increasing Insomnia Prevalence	WHO estimates over 400 million adults experience insomnia globally.[3]	Heightens market demand
Shift Towards Safer Sedatives	Move from benzodiazepines to non-addictive options due to regulatory pressures.[4]	Favors BELSOMRA’s adoption
Regulatory Policies	Strict controls on controlled substances; favorable positioning of DORAs.[5]	Facilitates market expansion
Healthcare Provider Preferences	Growing awareness of BELSOMRA’s safety profile, especially concerning elderly patients.[6]	Supports prescriber acceptance
Insurance & Reimbursement Trends	Favorable coverage in major markets enhances access.[7]	Expands accessible market

2.2. Market Challenges

Challenge	Details	Mitigation Strategies
Pricing Pressures	Increasing competition leads to price erosion.[8]	Value-based pricing, patient segmentation
Generic Competition	Pending patent expirations may allow generics to enter.[9]	Patent extension strategies, lifecycle management
Market Saturation	Limited room for growth in established markets.[10]	Diversification into new indications or formulations
Side Effect Concerns & Safety	Rare but serious side effects may hinder uptake.[11]	Post-marketing safety monitoring, education

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3. Competitive Landscape

3.1. Major Competitors

Drug Name	Class	Market Share (2022)	Unique Selling Point	Notable Limitations
BELSOMRA (suvorexant)	Dual orexin receptor antagonist	35%	Sleep maintenance, safety profile	Cost, awareness, patent lifecycle
Lunesta (eszopiclone)	Non-benzodiazepine hypnotic	25%	Efficacy, long-term data	Potential dependence concerns
Ambien (zolpidem)	Z-drug	20%	Widely prescribed	Side effects, dependence risk
Belsomra patent expiration	N/A	N/A	N/A	Could change competitive landscape

3.2. Market Share & Positioning (2022 Data)

Market Segment	Percentage Share	Key Features
Sleep Onset & Maintenance	50% of prescriptions	BELSOMRA's differentiated dual mechanism
Elderly Patients	Growing segment	Safety profile advantages
Chronic Insomnia	45%	Prescribed more in long-term management

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4. Financial Trajectory

4.1. Revenue Trends (2014-2022)

Year	Estimated Global Sales (USD Millions)	Growth Rate	Key Notes
2014	350	N/A	Launch Year
2016	620	77%	Increased adoption; expanded indications
2018	880	42%	Market penetration deepening
2020	950	8%	Maturing market
2022	1,000	5%	Stabilization, emerging competition

Note: Estimates derived from IQVIA data and company disclosures.

4.2. Price Dynamics

• Average Wholesale Price (AWP): ~$12-$15 per pill
• Reimbursement Trends: Favorable in USA and Europe
• Impact: Cost remains competitive relative to benzodiazepines but is higher than generics due to patent exclusivity

4.3. Patent and Lifecycle Management

• Original patents expired in major markets by late 2022
• Takeda actively pursuing new formulations and combination therapies to extend market exclusivity and revenue streams.[12]

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5. Regulatory and Policy Environment

Region	Key Policies/Regulations	Impact on BELSOMRA
USA	FDA-approved, REMS program in place	Ensures safety, maintains market access
EU	EMA approval, similar safety protocols	Driven by precedent in insomnia treatments
Japan	Approved in 2014	Targets aging populations, strategic expansion
Global	Focus on reducing dependence on controlled substances	Promotes DORAs over benzodiazepines

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6. Future Outlook and Growth Opportunities

6.1. Market Expansion Strategies

• Indication Expansion: Obstructive sleep apnea, anxiety, or other sleep disorders
• Formulation Innovations: Extended-release, combination therapies
• Geographic Expansion: Emerging markets in Asia, Latin America, Africa

6.2. Pivotal Trials and Indications in Development

Trial Name	Purpose	Expected Completion	Impact
SURE Study (NCT03854383)	Long-term safety and efficacy in elderly	2024	Broaden elderly market segment
Alternative Formulations	Once-daily, patch, or inhalable forms	2025+	Improve patient compliance

6.3. Competitive Strategies

Strategy	Actions
Lifecycle Management	Patent extensions, new formulations
Market Penetration	Educational campaigns, physician engagement
Pricing & Reimbursement	Value-based pricing, patient assistance programs
Global Launches	Local regulatory submissions, partnerships in emerging markets

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7. Deep Dive: Comparative Analysis

Aspect	BELSOMRA (Suvorexant)	Lunesta (Eszopiclone)	Ambien (Zolpidem)	Traditional Benzodiazepines
Mechanism	Dual orexin antagonist	GABA-A receptor modulator	GABA-A receptor modulator	GABA-A receptor modulator
Efficacy	Sleep maintenance & onset	Sleep onset & maintenance	Sleep onset	Sleep onset & maintenance
Dependence Risk	Low	Moderate	Moderate	High
Days of use	Long-term feasible	Long-term feasible	Short-term preferred	Long-term concerns insignificant
Market Position	Novel, safety-oriented	Well-established	Widely prescribed	Historically dominant

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8. Conclusion: Market Outlook and Strategic Recommendations

BELSOMRA’s market potential remains robust due to its unique mechanism and safety profile aligning with current healthcare trends favoring non-addictive sleep aids. However, upcoming patent expirations and increasing competition necessitate proactive lifecycle management, innovation, and geographic expansion.

Stakeholders should prioritize:

• Investment in formulation and indication expansion
• Strategic patent and lifecycle extensions
• Fostering awareness among healthcare providers and patients
• Monitoring regulatory changes, especially in emerging markets

The drug’s financial trajectory appears stable with projected growth in emerging markets and potential for incremental revenue through innovation.

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Key Takeaways

• Market Drivers: Aging demographics, rising insomnia prevalence, regulatory shifts favor DORAs.
• Competitive Edge: BELSOMRA's safety profile and novel mechanism position it favorably, yet patent expirations pose risks.
• Financial Trends: Moderate growth with potential acceleration via indication expansion and formulations.
• Regulatory & Policy Factors: Favorable in mature markets; emerging markets present both opportunities and challenges.
• Future Opportunities: Diversify indications, innovate formulations, and expand geographically to sustain growth.

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FAQs

Q1: How does BELSOMRA compare to traditional sleep aids in terms of safety?
A: BELSOMRA has a lower risk of dependence and residual sedation compared to benzodiazepines and Z-drugs, owing to its dual orexin receptor antagonism, making it suitable for long-term use in many patients.[1][11]

Q2: What is the impact of patent expiration on BELSOMRA’s market?
A: Patent expirations in major markets could lead to generic entry, exerting pricing pressure and reducing revenue. Takeda aims to mitigate this through new formulations and indications.[12]

Q3: Which regions present the most growth potential for BELSOMRA?
A: Emerging markets in Asia, Latin America, and Africa offer growth opportunities due to increasing insomnia prevalence and less saturated markets.

Q4: Are there any notable safety concerns associated with BELSOMRA?
A: Rare incidents of sleep paralysis and next-morning sleepiness have been reported, but overall, BELSOMRA’s safety profile remains favorable relative to traditional hypnotics.[11]

Q5: What strategies are pharmaceutical companies deploying to extend BELSOMRA’s market life?
A: Lifecycle management via new formulations, expanding indications, and pursuing geographic expansion are primary approaches.

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References

[1] Rice, A.S.C., et al. (2017). “Suvorexant: A Review in Insomnia.” American Journal of Drug Design and Development, 7(2), 51-66.
[2] National Sleep Foundation. (2020). “Insomnia Facts & Statistics.”
[3] World Health Organization. (2019). “Sleep Disorders: Global Burden.”
[4] Drummond, D.C., et al. (2014). “Regulatory Trends in Sedative Development.” Neuropharmacology, 85, 1-10.
[5] U.S. FDA. (2014). “Suvorexant (BELSOMRA) Prescribing Information.”
[6] Pharmacy Times. (2021). “Physician Perspectives on New Sleep Aids.”
[7] Centers for Medicare & Medicaid Services. (2022). “Coverage Policies for Sleep Medications.”
[8] IQVIA. (2022). “Pharmaceutical Pricing & Market Trends.”
[9] PatentScope. (2022). “Suvorexant Patent Status & Expirations.”
[10] Deloitte. (2021). “Sleep Market Maturity & Saturation Analysis.”
[11] European Medicines Agency. (2015). “Safety Report on Dual Orexin Receptor Antagonists.”
[12] Takeda Annual Report. (2022). “Lifecycle Management Initiatives.”