SUNOSI Drug Patent Profile

When do Sunosi patents expire, 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 ninety-four 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 twenty 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:	94
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
Axsome Therapeutics, Inc.	Phase 2
Johns Hopkins University	Phase 2
National Multiple Sclerosis Society	Phase 2

See all SUNOSI clinical trials

Pharmacology for SUNOSI

Drug Class	Dopamine and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors

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
Mexico	390083
European Patent Office	1890684	Traitement de troubles du cycle sommeil-éveil (Treatment of sleep-wake disorders)
China	109906078	(R)-2-氨基-3-苯丙基氨基甲酸酯的制剂 (FORMULATIONS OF ( R)-2-AMINO-3-PHENYLPROPYL CARBAMATE)
China	121202731	(R)-2-氨基-3-苯丙基氨基甲酸酯盐酸盐的晶体、其组合物及用途
Russian Federation	2417077	СПОСОБ ЛЕЧЕНИЯ ЧРЕЗМЕРНОЙ ДНЕВНОЙ СОНЛИВОСТИ (ВАРИАНТЫ) (METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS (VERSIONS))
Spain	2937795
China	120574152

Supplementary Protection Certificates for SUNOSI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1890684	2020C/004	Belgium		PRODUCT NAME: SOLRIAMFETOL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, BIJ VOORKEUR EEN HYDROCHLORIDE ZOUT DAARVAN; AUTHORISATION NUMBER AND 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	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	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	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	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

SUNOSI (Solriamfetol): Market Dynamics and Financial Trajectory

Last updated: April 23, 2026

How is SUNOSI positioned in the market?

SUNOSI (solriamfetol) is an oral, once-daily treatment for excessive daytime sleepiness associated with obstructive sleep apnea (OSA) and narcolepsy. Commercially, the drug sits at the intersection of sleep medicine and psychiatry-adjacent wakefulness pharmacology, with demand driven by diagnosis rates, adherence, payer coverage, and competitive substitution within wake-promoting therapy classes.

Key market posture:

• Indication breadth across both OSA and narcolepsy supports label expansion tailwinds when clinicians follow diagnostic workflows.
• Wake-promotion efficacy claims align with a clear patient-relevant endpoint (daytime sleepiness), supporting formulary narratives for targeted patient subsets.
• Class competition comes from other wake-promoting agents and treatment paradigms that reduce reliance on sleepiness-directed monotherapy.

What demand drivers shape sales over time?

Sales dynamics typically follow four levers for sleepiness medicines:

1. Diagnosis and treatment penetration

   • OSA diagnosis and titration pipelines determine the addressable base.
   • Narcolepsy is rarer, but it is commercially sticky when patients achieve functional improvement and remain adherent.

2. Payer access and formulary placement

   • Wake-promoting therapies often require prior authorization for coverage of non-preferred agents and to document excessive sleepiness severity.
   • Copay design and step therapy can materially affect uptake in managed care.

3. Adherence to long-term daily therapy

   • SUNOSI is taken chronically for sustained wakefulness benefit.
   • Long-term persistence is sensitive to perceived efficacy, tolerability, and prescriber switching patterns.

4. Clinical and competitive substitution

   • The presence of alternative therapies for both OSA-related sleepiness and narcolepsy changes marginal switching behavior.
   • Any new evidence, guideline shifts, or formulary updates can re-route share within class.

What is the financial trajectory for SUNOSI based on reported results?

For a defensible financial trajectory, the most reliable anchor is company-reported revenue (not estimates). SUNOSI’s commercialization is tied to its marketing owner’s reporting. The reporting baseline below uses the company’s disclosed revenue for the product.

Reported product revenue (SUNOSI)	Reporting period	SUNOSI revenue	Source
Full year 2023	Not provided in the available dataset here
Full year 2024	Not provided in the available dataset here
Quarterly 2024/2025	Not provided in the available dataset here

No numeric revenue figures are included in the input material available in this chat, so a complete and accurate financial trajectory with growth rates, quarterly inflections, and segment attribution cannot be produced under the operating constraints.

Which market events typically move SUNOSI sales?

Even without numeric revenue here, SUNOSI’s sales trajectory usually reacts to the following event types that influence share and coverage:

• Formulary and utilization changes in major commercial plans (preferred status, prior authorization criteria, step edits).
• Pricing and rebate dynamics (net price erosion or improvements tied to contracting).
• Competitive launches or label updates across wake-promoting agents.
• Safety/tolerability trends that change persistence (dose adjustments, discontinuation patterns).
• Healthcare utilization shifts tied to sleep center capacity and patient diagnostic flow.

How does payer policy affect access for sleepiness drugs like SUNOSI?

Access is often governed by the two-stage process used for specialty and controlled cardiovascular-risk-adjacent therapies:

• Step therapy / prior authorization: documentation of excessive daytime sleepiness, confirmed OSA with appropriate evaluation (for that indication), or narcolepsy diagnosis criteria.
• Quantity limits: consistent with once-daily dosing, but coverage can still be constrained by early refill rules or plan-specific limits.
• Renewal requirements: continued coverage frequently depends on improvement in sleepiness or functional outcomes.

These mechanisms typically determine the speed of uptake after prescribing adoption and shape the slope of sales after formulary wins or losses.

What are the key commercialization implications for investors and R&D planners?

When a wake-promoting therapy’s revenue scales, the pattern is usually driven by:

• Share conversion from incumbent agents via payer narratives and perceived efficacy/tolerability.
• Sustained persistence through manageable side effects and consistent benefit.
• Channel strength from sleep specialists and durable referral networks (sleep labs, neurology sleep clinics, pulmonology).

For R&D strategy, the market structure implies that incremental product value must translate into:

• better persistence,
• easier formulary access,
• or clearer differentiation in patient subsets (OSA vs narcolepsy, comorbidity-driven choice).

Where does SUNOSI sit versus alternative wake-promoting options?

In the wake-promoting segment, clinicians often choose based on:

• indication fit (OSA vs narcolepsy),
• cardiovascular and psychiatric tolerability,
• dosing convenience,
• payer access,
• and patient-specific response.

SUNOSI’s commercial success depends on maintaining a value proposition that survives contracting and prescribing inertia.

What can be concluded from available data here?

This chat contains no disclosed revenue figures, net sales, gross-to-net details, or guidance language specific to SUNOSI. Under the constraints, a complete, accurate financial trajectory cannot be delivered without those numeric inputs.

What can be stated from the label-level market mechanics:

• SUNOSI demand is structurally driven by chronic use, managed care coverage, and diagnostic penetration for OSA and narcolepsy.
• Sales growth or decline typically maps to formulary outcomes, persistence, and competitive substitution within wake-promoting therapies.

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Key Takeaways

• SUNOSI’s market demand is anchored to chronic daily therapy for excessive daytime sleepiness in OSA and narcolepsy.
• Growth is mainly governed by diagnosis/titration pipelines, payer access (prior authorization and preferred status), and persistence.
• A numeric financial trajectory cannot be quantified from the provided material; no product revenue figures were included here to support year-by-year or quarter-by-quarter conclusions.

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FAQs

1. What indications drive SUNOSI sales?
   Excessive daytime sleepiness in obstructive sleep apnea and narcolepsy.

2. Why do payers influence SUNOSI uptake so strongly?
   Managed care commonly uses prior authorization and renewal criteria tied to documented sleepiness and diagnosis.

3. What factor most affects long-term SUNOSI revenue?
   Patient persistence on chronic daily therapy, which depends on sustained perceived benefit and tolerability.

4. How does competition typically affect SUNOSI’s market share?
   Competitive switching depends on payer placement, perceived efficacy, and tolerability, which influence both new starts and discontinuations.

5. What is required to build a precise financial trajectory?
   Disclosed SUNOSI net sales or product revenue by period (quarterly and full-year) and related guidance language.

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References

[1] U.S. Food and Drug Administration. SUNOSI (solriamfetol) prescribing information.