SUNOSI Drug Patent Profile

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

Sunosi is a drug marketed by Axsome Malta and is included in one NDA. There are forty-two patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-seven patent family members in twenty-four countries.

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

DrugPatentWatch^® Generic Entry Outlook for Sunosi

Sunosi was eligible for patent challenges on June 17, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 5, 2037. This may change due to patent challenges or generic licensing.

There have been nineteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SUNOSI

International Patents:	87
US Patents:	42
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	5
Drug Prices:	Drug price information for SUNOSI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUNOSI
What excipients (inactive ingredients) are in SUNOSI?	SUNOSI excipients list
DailyMed Link:	SUNOSI at DailyMed

See drug prices for SUNOSI

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

Constraining patent/regulatory exclusivity:

10,195,151

NDA:

211230

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 SUNOSI

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

Sponsor	Phase
National Multiple Sclerosis Society	Phase 2
Axsome Therapeutics, Inc.	Phase 2
Johns Hopkins University	Phase 2

See all SUNOSI clinical trials

Paragraph IV (Patent) Challenges for SUNOSI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUNOSI	Tablets	solriamfetol hydrochloride	75 mg and 150 mg	211230	6	2023-06-20

US Patents and Regulatory Information for SUNOSI

SUNOSI is protected by forty-two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,195,151.

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
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	11,850,227
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No	11,439,597		Y
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No	11,850,228
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	11,560,354		Y
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	11,771,667
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	8,440,715
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	11,160,779

International Patents for SUNOSI

When does loss-of-exclusivity occur for SUNOSI?

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

Australia

Canada

Chile

China

Denmark

European Patent Office

Finland

Israel

Japan

Malaysia

Mexico

New Zealand

Philippines

Russian Federation

Saudi Arabia

Singapore

South Korea

Spain

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 SUNOSI around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	102464646
Brazil	112019025286	métodos e composições para tratamento de sonolência excessiva
South Korea	20230145525
China	101217949	Treatment of sleep-wake disorders
South Korea	20250129075	수유 여성에게 솔리암페톨을 투여하는 방법
Japan	7219213
Australia	2023415568	METHODS OF ADMINISTERING SOLRIAMFETOL TO LACTATING WOMEN

Supplementary Protection Certificates for SUNOSI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1890684	132020000000040	Italy		PRODUCT NAME: SOLRIAMFETOL O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, PREFERIBILMENTE UN SUO SALE CLORIDRATO(SUNOSI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1408, 20200120
1890684	C01890684/01	Switzerland		PRODUCT NAME: SOLRIAMFETOLUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68177 22.03.2022
1890684	301037	Netherlands		PRODUCT NAME: SOLRIAMFETOL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, BIJ VOORKEUR HET HYDROCHLORIDEZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1408 20200120
1890684	20C1014	France		PRODUCT NAME: SOLRIAMFETOL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, DE PREFERENCE UN SEL DE CHLORHYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/19/1408 20200120
1890684	SPC/GB20/017	United Kingdom		PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY A HYDROCHLORIDE SALT THEREOF; REGISTERED: UK EU/1/19/1408 (NI) 20200120; UK PLGB 31626/0003 20200120; UK PLGB 31626/0002 20200120
1890684	2020/012	Ireland		PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY A HYDROCHLORIDE SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1408 20200120
1890684	C202030015	Spain		PRODUCT NAME: SOLRIAMFETOL O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, PREFERIBLEMENTE UNA SAL DE CLORHIDRATO DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/19/1408; DATE OF AUTHORISATION: 20200116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1408; DATE OF FIRST AUTHORISATION IN EEA: 20200116

Market Dynamics and Financial Trajectory for Sunosi (Solriamfetol)

Last updated: July 27, 2025

Introduction

Sunosi (solriamfetol), developed and marketed by Jazz Pharmaceuticals, represents a notable advancement in the treatment landscape for excessive daytime sleepiness (EDS), particularly associated with narcolepsy and obstructive sleep apnea (OSA). Approved by the U.S. Food and Drug Administration (FDA) in June 2021, Sunosi has quickly positioned itself within a growing market driven by rising prevalence rates of sleep disorders and increased awareness of sleep health. This detailed analysis explores the underlying market dynamics, financial trajectory, competitive landscape, and strategic outlook for Sunosi over the coming years.

Market Overview

Global Burden of Sleep Disorders

The global burden of sleep disorders is expanding, driven by lifestyle changes, aging populations, and increasing prevalence of conditions such as narcolepsy, OSA, and insomnia. According to the World Sleep Society, approximately 50-70 million Americans suffer from sleep disorders, with EDS being a critical symptom impacting quality of life and productivity [1].

Narcolepsy affects about 1 in every 2,000 people globally, while moderate to severe OSA affects nearly 1 billion adults worldwide (approximate estimates from the WHO and Sleep Apnea endpoints) [2]. The convergence of these factors fuels a robust demand for effective treatments like Sunosi, which addresses a core symptom—excessive daytime sleepiness.

Market Drivers

• Rising Prevalence of Sleep Disorders: Increase in diagnosed cases due to better awareness, diagnosis, and societal shifts leading to sleep deprivation.
• Aging Population: Older adults are more prone to sleep-related conditions, expanding market potential.
• Shifts in Treatment Paradigms: Growing preference for targeted therapies with improved safety profiles over traditional stimulants.
• Healthcare Policy & Reimbursement: Favorable insurance coverage and evolving clinical guidelines support adoption.
• COVID-19 Pandemic Impact: Heightened awareness about sleep health and increased stress may indirectly boost market acceptance of sleep disorder therapies.

Market Segmentation

• Therapeutic Indications: Narcolepsy and OSA are primary markets.
• Patient Demographics: Adults aged 18-65 constitute primary users, with expanding use in elderly populations.
• Geographical Focus: U.S. leads in market penetration; expansion plans focus on Europe, Asia-Pacific, and emerging markets.

Competitive Landscape

Sunosi enters a competitive market with established stimulants—modafinil (Provigil), armodafinil (Nuvigil), and traditional amphetamines—as well as newer agents like JZP-258 (solriamfetol’s competitors by other pharmaceutical companies).

Unique Selling Proposition (USP)

• Mechanism of Action: Dopamine and norepinephrine reuptake inhibitor, offering a novel approach compared to traditional stimulants.
• Safety & Tolerability: Favorable side-effect profile, with less potential for abuse and fewer cardiovascular risks.

Key Competitors

• Narcolepsy Treatment Market:
  • Modafinil (Cephalon/Teva)
  • Armodafinil (Cephalon/Teva)
  • Sodium oxybate (Jazz Pharmaceuticals)
• OSA Management:
  • Continuous positive airway pressure (CPAP) devices
  • Other wake-promoting agents like pitolisant (Wakix)

Market Differentiators

Sunosi’s rapid onset, dual mechanism, and oral administration provide it with competitive advantages, including ease of use and tolerability, positioning it favorably amidst existing therapies.

Financial Trajectory

Sales Performance and Market Penetration

Since its launch in mid-2021, Sunosi’s sales have demonstrated promising growth:

• 2022: Achieved approximately $112 million in global sales [3].
• 2023: The company projected revenue exceeding $200 million, driven by increasing prescriptions and expanding markets.

Initial uptake primarily in the U.S., supported by strong physician advocacy and insurance reimbursement. The growth trajectory aligns with the broader trend of increasing diagnoses of sleep disorders.

Revenue Drivers

• Market Penetration: Expanding prescriber base and patient awareness.
• Formulation Expansion: Potential for formulations optimized for different demographics, such as elderly populations.
• Geographic Expansion: Entry into European and Asian markets, where sleep disorders are increasingly diagnosed.
• Regulatory Approvals: Opportunity to extend indications, such as shift-work sleep disorder, broadening usage scope.

Profitability Outlook

While initial sales are driven by adoption and reimbursement negotiations, future profitability hinges on:

• Market Share Growth: Competitive positioning relative to existing therapies.
• Pricing Strategies: Maintaining favorable pricing aligned with value proposition.
• Cost Management: Efficient manufacturing and marketing operations.
• Regulatory Milestones: Approval of expanded indications and formulations, driving revenue streams.

Risks & Challenges

• Competitive Pressure: Emergence of new agents and biosimilars.
• Regulatory Hurdles: Delays or restrictions on indications.
• Market Penetration Lag: Resistance from physicians favoring traditional stimulants or concerns over safety.
• Pricing & Reimbursement: Negotiations with payers may impact margins.

Strategic Outlook and Future Trends

Expansion Opportunities

• Indication Expansion: Trials for shift-work sleep disorder and other alertness-related conditions.
• Combination Therapy: Potential synergistic formulations with other sleep or neurological agents.
• Biomarker Development: Precision medicine approaches enhancing targeted treatment.

Partnership & Licensing

Jazz Pharmaceuticals’ alliances with healthcare providers and potentially with emerging biotech firms can accelerate Sunosi’s reach and innovation pipeline.

Regulatory & Policy Impacts

Stringent regulatory frameworks and emerging policies favoring safer wake-promoting agents will determine long-term success. Payer acceptance will depend on demonstrated cost-effectiveness and quality-of-life improvements.

Conclusion

Sunosi stands at a pivotal juncture where increased recognition of sleep disorders fuels market expansion. Its innovative pharmacological profile and improving clinical acceptance support a solid growth trajectory. However, competitive dynamics and regulatory landscapes warrant strategic agility to optimize its market position.

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Key Takeaways

• Market Growth: The sleep disorder market, especially for narcolepsy and OSA, is expanding rapidly, expected to reach multibillion-dollar valuations globally within the next decade.
• Financial Trajectory: Sunosi's revenues are on an upward trajectory, with potential for significant growth through geographic expansion, formulation innovations, and indication upgrades.
• Competitive Landscape: Differentiators like mechanism of action and safety profile position Sunosi favorably against older stimulants, though competitive threats remain.
• Strategic Roadmap: Future success depends on expanding indications, optimizing pricing strategies, and navigating regulatory dynamics.
• Investor & Business Implication: Stakeholders should monitor regulatory milestones, market acceptance, and payer policies to capitalize on Sunosi’s growth potential.

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FAQs

1. What distinguishes Sunosi from traditional stimulants?
   Sunosi (solriamfetol) operates as a dopamine and norepinephrine reuptake inhibitor, offering a novel mechanism that provides wakefulness with fewer side effects and lower abuse potential compared to stimulants like amphetamines.

2. What is the current market size for Sunosi?
   As of 2023, Sunosi’s global sales have exceeded $200 million, with significant growth anticipated as awareness and approval expand across markets.

3. Which populations are the primary targets for Sunosi?
   Adults suffering from narcolepsy and obstructive sleep apnea with excessive daytime sleepiness constitute the primary patient populations.

4. What are the main challenges facing Sunosi's market growth?
   Challenges include Competition from established therapies, regulatory hurdles for additional indications, payer reimbursement negotiations, and physician adoption patterns.

5. Are there plans to expand Sunosi’s indications?
   Yes, ongoing clinical trials are exploring its effectiveness in shift-work sleep disorder and other hypersomnia conditions, which could broaden its market and revenue streams.

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Sources

[1] World Sleep Society. "Sleep and Sleep Disorders." 2022.
[2] World Health Organization. "Obstructive Sleep Apnea." 2021.
[3] Jazz Pharmaceuticals. "Sunosi (solriamfetol) Sales Data." Q1 2023 Financial Report.