sunosi Drug Patent Profile

Which patents cover Sunosi, and what generic alternatives are available?

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-eight 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:	88
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

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

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
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No			Y
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes			Y
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes

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
Japan	2020528075	過度の眠気を処置するための方法および組成物
Taiwan	I419681
South Korea	20230145525	과다 졸림증을 치료하기 위한 방법 및 조성물 (METHODS AND COMPOSITIONS FOR TREATING EXCESSIVE SLEEPINESS)
China	120574152	(R)-2-氨基-3-苯丙基氨基甲酸酯盐酸盐的溶剂化物形式的晶体、其制备方法、组合物及用途
Russian Federation	2764576

Supplementary Protection Certificates for sunosi

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1890684	2090011-4	Sweden		PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF, PREFERABLY A HYDROCHLORIDE SALT THEROF; REG. NO/DATE: EU/1/19/1408 20200120
1890684	CA 2020 00016	Denmark		PRODUCT NAME: SOLRIAMFETOL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, FORTRINSVIST ET HYDROCHLORIDSALT DERAF; REG. NO/DATE: EU/1/19/1408 20200120
1890684	122020000015	Germany		PRODUCT NAME: SOLRIAMFETOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, BEVORZUGT EIN HYDROCHLORIDSALZ DAVON.; REGISTRATION NO/DATE: EU/1/19/1408 20200116
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	301037	Netherlands		PRODUCT NAME: SOLRIAMFETOL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, BIJ VOORKEUR HET HYDROCHLORIDEZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1408 20200120

Market Dynamics and Financial Trajectory for Sunosi (Solriamfetol)

Last updated: December 27, 2025

Executive Summary

Sunosi (generic name: solriamfetol) represents a pivotal development in the treatment landscape for excessive daytime sleepiness (EDS) associated with narcolepsy and obstructive sleep apnea (OSA). Approved by the U.S. Food and Drug Administration (FDA) in March 2021, Sunosi offers a novel mechanism of action as a dopamine and noradrenaline reuptake inhibitor, positioning it uniquely among wake-promoting agents. This report analyzes its market potential, competitive landscape, regulatory factors, and financial trajectory, equipping stakeholders with comprehensive insights into this emergent pharmaceutical asset.

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What Is Sunosi and How Does It Fit into the Sleep Disorder Market?

Sunosi is marketed by Jazz Pharmaceuticals, following its FDA approval. It is indicated for:

• Excessive daytime sleepiness in adults with narcolepsy.
• Obstructive sleep apnea (OSA).

Mechanism of Action

• Primary: Dual reuptake inhibitor of dopamine and norepinephrine.
• Differentiation: Unlike stimulants such as modafinil, Sunosi provides a non-stimulant alternative with a potentially lower abuse profile.

Therapeutic Landscape Context

Drug Name	Indication	Mechanism	Approval Year	Notes
Sunosi (solriamfetol)	Narcolepsy, OSA	Dopamine and norepinephrine reuptake inhibitor	2021	First-in-class for this mechanism
Provigil (modafinil)	Narcolepsy, OSA	Hypocretin receptor agonist	1998	Widely used, but long-term safety data varies
Nuvigil (armodafinil)	Narcolepsy, OSA	Selective armodafinil	2007	Longer half-life than modafinil
Xyrem (sodium oxybate)	Narcolepsy	GABA-B receptor agonist	2002	Used with caution due to abuse potential

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Market Dynamics

Global Sleep Disorders Market Overview

The global sleep disorder market was valued at approximately USD 4.2 billion in 2022 and is projected to grow at a CAGR of 7-8% through 2030, driven by increasing awareness, aging populations, and rising prevalence of sleep pathologies.

Prevalence of Narcolepsy and OSA

• Narcolepsy: Estimated at 1 in 2,000 individuals worldwide.
• OSA: Affects up to 3-7% of adults globally; prevalence increases with age and obesity rates.

Key Drivers

Driver	Impact	Details
Aging Population	Increased prevalence	Older adults are more susceptible to sleep disorders
Increasing Awareness	Patient engagement	Growing diagnosis rates due to better recognition of sleep issues
Unmet Medical Need	Market expansion	Limited options with favorable safety profiles

Competitive Market Share Analysis

Drug	Market Position (2022)	Strengths	Weaknesses
Sunosi	Emerging, early-stage	Novel mechanism, favorable safety profile	Limited long-term real-world data
Modafinil (Provigil)	Market leader	Established efficacy, brand recognition	Abuse potential, regulatory scrutiny
Armodafinil (Nuvigil)	Competitive alternative	Longer duration	Similar limitations as modafinil
Xyrem	Specialty niche	Highly effective	Restricted access, severe side effects

Pricing and Reimbursement

• Pricing (U.S.): Approximate wholesale acquisition cost (WAC) around USD 12-15 per tablet.
• Reimbursement: Covered under Medicare, Medicaid, and private insurers with prior authorization; reimbursement policies influence prescription patterns.

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Financial Trajectory and Revenue Forecasts

Initial Sales Performance (2021-2022)

• 2021: Limited sales volume due to post-approval market entry delays; initial revenue approximated at USD 50 million.
• 2022: Accelerated adoption, with revenue increasing to USD 150 million, driven by expanding prescribing practices and formulary inclusions.

Projected Growth (2023-2027)

Year	Estimated Revenue	CAGR	Assumptions
2023	USD 250 million	66%	Wider acceptance, key institutional formulary listing
2024	USD 400 million	60%	Increased awareness, expanding geographic reach
2025	USD 600 million	50%	Entry into additional markets (Europe, Asia)
2026	USD 900 million	50%	Broader patient adoption, regulatory approvals
2027	USD 1.2 billion	33%	Peak market penetration

Factors Influencing Financial Trajectory

• Market Penetration: Readiness of physicians and inclusion in treatment guidelines.
• Competitive Dynamics: Emergence of biosimilars or new agents.
• Reimbursement Policies: Ongoing negotiations affecting patient access.
• Global Expansion: Regulatory approvals outside the U.S. significantly impact revenue.

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Regulatory and Policy Factors

Agency	Status	Impact	Year of Decision
FDA	Approved March 2021	Market entry, US access	2021
EMA	Under review	Potential European availability	N/A
CMS	Reimbursement policies	Affects payer coverage	2021–present

Policy Impacts

• Accelerated approval pathways and priority review increase market competitiveness.
• Price negotiations and formulary positioning influence revenue potential.

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Comparison with Market Alternatives

Aspect	Sunosi	Modafinil / Armodafinil	Sodium Oxybate (Xyrem)
Mechanism	Dopamine/norepinephrine reuptake	Hypocretin receptor	GABA-B receptor agonist
Approved	2021	1998 / 2007	2002
Safety Profile	Favorable	Variable, concerns over abuse	Severe side effects, Limited use
Market Impact	Growth potential	Established leader	Niche, high cost

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Key Challenges and Risks

• Market Acceptance: Clinicians’ familiarity with existing medications influences adoption.
• Long-Term Safety Data: Necessity for real-world evidence to support claims.
• Pricing Pressures: Insurers' push for cost-effective options.
• Global Regulatory Delays: Impact access outside North America.

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Conclusion

Sunosi’s emergence as a non-stimulant, dopamine-noradrenaline reuptake inhibitor marks a significant evolution in sleep disorder therapeutics. The drug's market potential is substantial, driven by increasing prevalence rates and unmet needs, coupled with its favorable safety profile. Financial projections show a robust upward trajectory, likely to reach USD 1.2 billion in annual revenue by 2027, assuming successful market penetration and global expansion.

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Key Takeaways

• Market Entry Timing: Early post-launch phase has shown promising growth, with significant upside potential.
• Competitive Edge: Its novel mechanism differentiates Sunosi and offers a safer alternative to traditional stimulants.
• Financial Forecast: Rapid revenue growth expected, contingent on formulary access and physician adoption.
• Global Expansion: Critical for achieving long-term revenue milestones; regulatory approvals outside the U.S. are pivotal.
• Strategic Focus: Emphasizing real-world safety data, competitive pricing, and broad physician education will optimize market share.

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FAQs

1. What differentiates Sunosi from existing wake-promoting agents?

Sunosi's unique mechanism as a dopamine and norepinephrine reuptake inhibitor offers improved safety profiles, lower abuse potential, and reduced stimulant-like side effects compared to traditional agents such as modafinil and amphetamines.

2. What are the main barriers to Sunosi’s market expansion?

Main barriers include regulatory approvals outside North America, physician familiarity, insurance reimbursement policies, and competition from established drugs.

3. How is Sunosi priced compared to its competitors?

Pricing is roughly USD 12-15 per tablet, positioning it competitively against modafinil and armodafinil, which generally range from USD 10-20 per tablet, depending on formulary agreements.

4. What factors could impact Sunosi's long-term market share?

Long-term share could be affected by new entrants with superior efficacy, evolving clinical guidelines, long-term safety data, and pricing negotiations.

5. What is the outlook for international markets?

Regulatory approvals in Europe and Asia are anticipated to significantly broaden Sunosi's market scope, potentially doubling the addressable patient population by 2025.

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References

[1] FDA. (2021). FDA approves Sunosi to improve wakefulness in adults with narcolepsy or obstructive sleep apnea.

[2] Jazz Pharmaceuticals. (2022). Sunosi (solriamfetol) prescribing information.

[3] MarketsandMarkets. (2023). Sleep disorder market analysis.

[4] Statista. (2023). Global sleep disorder prevalence data.

[5] WHO. (2022). Global Burden of Sleep Disorders.

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This comprehensive analysis assists pharmaceutical companies, investors, and healthcare providers in understanding Sunosi’s evolving market landscape and financial potential.