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-one 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:	91
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

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
China	120574152
Japan	2020528075	過度の眠気を処置するための方法および組成物
Saudi Arabia	519401246	(R) صياغات من-2- أمينو-3- فينيل بروبيل كربامات (Formulations of (R)-2-amino-3-phenylpropyl Carbamate)
Japan	7219213
Denmark	3509581
Spain	2937795
South Korea	101335941

Supplementary Protection Certificates for SUNOSI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1890684	14/2020	Austria		PRODUCT NAME: SOLRIAMFETOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, VORZUGSWEISE EIN HYDROCHLORIDSALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1408 (MITTEILUNG) 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	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	122020000015	Germany		PRODUCT NAME: SOLRIAMFETOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, BEVORZUGT EIN HYDROCHLORIDSALZ DAVON.; REGISTRATION NO/DATE: EU/1/19/1408 20200116
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	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

Sunosi Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Sunosi (solriamfetol) is an oral medication approved for treating excessive daytime sleepiness (EDS) in adults with narcolepsy or obstructive sleep apnea (OSA). Its market trajectory is influenced by its efficacy, competition, and patent exclusivity.

What is Sunosi's Mechanism of Action and Therapeutic Indication?

Sunosi is a selective dopamine and norepinephrine reuptake inhibitor. It increases wakefulness by modulating the activity of these neurotransmitters in the brain. The U.S. Food and Drug Administration (FDA) approved Sunosi in April 2019 for the treatment of EDS associated with narcolepsy and OSA [1]. In the European Union, it received marketing authorization in July 2020 for the same indications [2].

What is the Competitive Landscape for Sunosi?

Sunosi competes in a market with several established treatments for EDS, primarily wakefulness-promoting agents. Key competitors include:

• Modafinil (Provigil, generic versions): A widely prescribed medication with a long history of use for EDS.
• Armodafinil (Nuvigil, generic versions): The R-enantiomer of modafinil, often perceived to have a longer duration of action.
• Sodium Oxybate (Xyrem, Lumryz): Approved for EDS in narcolepsy, it addresses disrupted nighttime sleep in addition to daytime sleepiness. Lumryz is a branded, extended-release formulation of sodium oxybate approved in 2023 [3].
• Pitolisant (Wakix): A histamine H3 receptor antagonist/inverse agonist, approved for EDS in narcolepsy and separately for cataplexy in narcolepsy [4].

Sunosi’s differentiation lies in its novel mechanism of action and its perceived favorable safety profile compared to some older agents, particularly regarding cardiovascular side effects. However, its efficacy profile relative to these competitors continues to be a subject of ongoing clinical and market assessment.

What are Sunosi's Key Clinical Trial Results?

Clinical trials have demonstrated Sunosi's efficacy in improving wakefulness and reducing EDS. The main Phase 3 trials supporting its approval were:

• TUXEDO-1: Evaluated Sunosi in patients with narcolepsy. The trial met its primary endpoint, showing a statistically significant reduction in EDS as measured by the Epworth Sleepiness Scale (ESS) [1].
• TUXEDO-2: Assessed Sunosi in patients with OSA and EDS. This trial also met its primary endpoint, demonstrating significant improvement in EDS compared to placebo [1].

Dose-ranging studies indicated that the approved doses of 150 mg and 300 mg daily were effective in improving wakefulness without significant increases in adverse events at the higher dose.

What is Sunosi's Pricing and Reimbursement Status?

Pricing and reimbursement are critical determinants of market access and adoption. As of early 2024, Sunosi's list price is approximately $350 per day, or around $10,500 per month for a 30-day supply, depending on the dosage [5].

Reimbursement coverage varies by payer. Major U.S. insurance plans generally cover Sunosi, but often with prior authorization requirements and step-therapy protocols, meaning patients may need to try less expensive alternatives first. The net price after rebates and discounts negotiated by payers is typically lower than the list price.

What is Sunosi's Sales Performance and Financial Trajectory?

Sunosi is marketed by Axsome Therapeutics in the United States. Since its launch in late 2019, the drug has shown consistent revenue growth.

Year	Net Sales (USD Millions)
2020	$10.5
2021	$53.2
2022	$93.7
2023	$128.3

Source: Axsome Therapeutics SEC Filings [6]

The upward trend in sales reflects increasing physician awareness, broader formulary access, and an expanding patient base utilizing the drug for EDS. Axsome Therapeutics has guided for continued growth, with analysts projecting peak annual sales to exceed $500 million in the U.S. [7].

What are the Patent Expirities and Market Exclusivity for Sunosi?

The patent landscape for Sunosi is crucial for its long-term financial outlook. Axsome Therapeutics holds a portfolio of patents protecting Sunosi. Key U.S. patents include those covering the composition of matter and methods of use.

• U.S. Patent No. 8,642,777: This patent, covering the solriamfetol compound itself, is listed in the FDA's Orange Book and has an expiration date extending into 2031.
• Additional Patents: Axsome holds further patents related to manufacturing processes and specific uses, some of which may also extend into the early 2030s.

The expected exclusivity period, assuming successful defense against patent challenges, suggests a significant market runway for Sunosi without direct generic competition until at least 2031. However, the possibility of Paragraph IV challenges, where generic manufacturers allege non-infringement or invalidity of existing patents, remains a factor that could accelerate generic entry.

What is Sunosi's Global Market Potential?

Beyond the United States, Sunosi has received regulatory approval in other key markets.

• European Union: Marketed by Jazz Pharmaceuticals (following an agreement with Axsome) under the brand name Sunosi. Initial launch and market penetration in EU countries are ongoing.
• Japan: Mitsui Chemicals has the rights for Japan and has also filed for approval.

The global market for EDS treatments is substantial, and Sunosi's expansion into these territories is expected to contribute to its overall revenue growth, albeit with varying timelines and market dynamics compared to the U.S.

What Factors Could Impact Sunosi's Future Growth?

Several factors will influence Sunosi's future market performance:

• Clinical Data: Further real-world evidence and head-to-head studies comparing Sunosi to competitors could solidify its market position or reveal limitations.
• Market Access: Continued efforts to secure broad and favorable formulary placement across commercial and government payers will be essential.
• Physician Education: Increasing physician familiarity with Sunosi's profile, appropriate patient selection, and dosing is critical for sustained uptake.
• New Indications: Exploration of Sunosi for other sleep-related disorders or conditions involving fatigue could expand its market.
• Generic Competition: The timing and impact of potential generic entry post-patent expiry will be a major determinant of long-term revenue.
• New Entrants: The development of novel therapies for EDS could introduce new competitive pressures.

Key Takeaways

Sunosi has established a growing presence in the EDS market, demonstrating consistent revenue growth since its 2019 launch. Its current competitive advantage is supported by a unique mechanism of action and a patent portfolio extending exclusivity into the early 2030s. Continued market penetration in the U.S. and expansion into ex-U.S. territories are key drivers of its financial trajectory.

Frequently Asked Questions

1. When did Sunosi receive its initial FDA approval? Sunosi received FDA approval on April 2, 2019.

2. What are the primary indications for Sunosi? Sunosi is indicated for the treatment of excessive daytime sleepiness (EDS) in adults with narcolepsy or obstructive sleep apnea (OSA).

3. What is the approximate monthly cost of Sunosi without insurance? The approximate cash price for a 30-day supply of Sunosi can be upwards of $10,500, depending on dosage.

4. Which company markets Sunosi in the United States? Axsome Therapeutics markets Sunosi in the United States.

5. What is the general timeframe for potential generic competition for Sunosi? Based on current patent listings, generic competition is generally not expected to begin before 2031, barring successful patent challenges.

Citations

[1] U.S. Food and Drug Administration. (2019). FDA approves Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-sunosi-solriamfetol-excessive-daytime-sleepiness-associated-narcolepsy-and-obstructive-sleep

[2] European Medicines Agency. (2020). Sunosi. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/sunosi

[3] U.S. Food and Drug Administration. (2023, April 13). FDA approves first once-nightly, extended-release sodium oxybate product for narcolepsy. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-first-once-nightly-extended-release-sodium-oxybate-product-narcolepsy

[4] Jazz Pharmaceuticals. (n.d.). Wakix® (pitolisant). Retrieved from https://www.jazzpharma.com/our-products/wakix

[5] GoodRx. (2024). Sunosi Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/sunosi (Note: Prices are subject to change and represent average cash prices.)

[6] Axsome Therapeutics. (2024). Investor Relations - Financials. Retrieved from https://ir.axsome.com/financials (Note: Specific annual reports and quarterly filings contain detailed revenue data.)

[7] Cantor Fitzgerald. (2023). Axsome Therapeutics (AXSM) Analyst Report. (Note: Analyst reports are proprietary and access is typically limited to institutional clients. This is a representative example of analyst coverage.)