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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 thirty-six patents protecting this drug and one Paragraph IV challenge.

This drug has seventy patent family members in twenty-three 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 has been one patent litigation case 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:	70
US Patents:	36
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	5
Patent Applications:	114
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 thirty-six US patents and two FDA Regulatory Exclusivities.

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	11,439,597		Y
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	10,351,517
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No	12,005,036
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	11,793,776
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	11,839,599
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	12,064,411

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

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
Philippines	12019502723	METHODS AND COMPOSITIONS FOR TREATING EXCESSIVE SLEEPINESS
World Intellectual Property Organization (WIPO)	2009112459
Japan	2011514906
Australia	2018278332	Methods and compositions for treating excessive sleepiness
Japan	2019533640	（Ｒ）−２−アミノ−３−フェニルプロピルカルバメートの製剤
World Intellectual Property Organization (WIPO)	2006133393

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
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 Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sunosi

Introduction to Sunosi

Sunosi, also known as solriamfetol, is a dual-acting dopamine and norepinephrine reuptake inhibitor developed by Axsome Therapeutics. It is indicated to improve wakefulness in adult patients with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA)[1].

Market Performance

Prescription Growth

In the second quarter of 2024, Sunosi demonstrated significant growth with over 45,000 prescriptions written in the United States. This represents an 8% increase from the first quarter of 2024 and a 15% growth compared to the second quarter of 2023. Notably, more than 4,200 new patients initiated Sunosi treatment during this quarter, and approximately 400 new prescribers were activated[1].

Market Share

While the overall wake-promoting agent market grew only 4% sequentially and declined 1% compared to the second quarter of 2023, Sunosi outperformed this trend. This strong performance indicates Sunosi's increasing adoption among sleep specialists in the United States[1].

Financial Performance

Revenue

For the second quarter of 2024, Sunosi generated $22.1 million in net product revenue, comprising $21.5 million in net product sales and $0.6 million in royalty revenue from out-licensed territories. This represents a 16% year-over-year growth from $19.1 million in the comparable period of 2023[1].

In the full year of 2023, Sunosi contributed significantly to Axsome Therapeutics' total product revenues. The drug generated $74.8 million in net product sales, with total Sunosi revenue, including license revenue, reaching $140.5 million[2].

Payer Coverage

Sunosi maintained stable payer coverage during the second quarter of 2024, with 95% of lives covered. This consistent coverage is crucial for the drug's continued market penetration and patient access[1].

Expansion and Development

New Indications

Axsome Therapeutics is actively pursuing additional indications for solriamfetol. These include attention deficit hyperactivity disorder (ADHD), major depressive disorder, binge eating disorder, and excessive sleepiness associated with shift work disorder. The SUSTAIN study, a phase 3 trial evaluating solriamfetol for shift work disorder, is ongoing with topline results anticipated in 2026[1].

Clinical Trials

The company's robust development pipeline includes other promising candidates like AXS-12, a novel norepinephrine reuptake inhibitor and cortical dopamine modulator for narcolepsy. AXS-12 has shown positive results in completed phase 3 and phase 2 trials and is currently in a phase 3 open-label safety extension trial with topline results expected in the fourth quarter of 2024[1].

Competitive Landscape

Market Competition

Despite stiff competition in the neuroscience and sleep disorder markets, Sunosi has managed to carve out a significant niche. The acquisition of Sunosi from Jazz Pharmaceuticals in May 2022 diversified Axsome's portfolio and helped the company reach a larger patient population, driving growth prospects[4].

Pipeline Candidates

Axsome's impressive pipeline, including candidates like AXS-07 for the acute treatment of migraine, further enhances the company's competitive position. The FDA's acceptance of the resubmitted new drug application (NDA) for AXS-07 is a positive indicator of the company's future growth potential[4].

Financial Outlook

Revenue Projections

Axsome Therapeutics estimates that Sunosi has peak revenue potential of greater than $1 billion, considering its current indications and potential new indications. This projection underscores the drug's significant contribution to the company's financial trajectory[3].

Expenses and Losses

While Sunosi has been a revenue driver, Axsome Therapeutics has incurred significant expenses related to research and development, commercialization, and other activities. For the first quarter of 2024, the company reported a net loss of $68.4 million, largely due to increased research and development expenses and commercialization activities[5].

Key Takeaways

• Prescription Growth: Sunosi saw an 8% increase in prescriptions from Q1 2024 and a 15% growth compared to Q2 2023.
• Revenue: Sunosi generated $22.1 million in net product revenue in Q2 2024, with a 16% year-over-year growth.
• Payer Coverage: Stable payer coverage with 95% of lives covered.
• New Indications: Ongoing trials for additional indications such as ADHD, major depressive disorder, and shift work disorder.
• Financial Outlook: Estimated peak revenue potential of over $1 billion.
• Competitive Position: Strong performance despite market competition, with a diversified portfolio and robust pipeline.

FAQs

Q: What is Sunosi used for? A: Sunosi is used to improve wakefulness in adult patients with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA).

Q: How has Sunosi performed in terms of prescriptions in 2024? A: Sunosi prescriptions increased by 8% in Q2 2024 compared to Q1 2024 and by 15% compared to Q2 2023.

Q: What is the current revenue status of Sunosi? A: In Q2 2024, Sunosi generated $22.1 million in net product revenue, representing a 16% year-over-year growth.

Q: Is Sunosi being developed for other indications? A: Yes, Axsome Therapeutics is pursuing additional indications for Sunosi, including ADHD, major depressive disorder, binge eating disorder, and excessive sleepiness associated with shift work disorder.

Q: What is the estimated peak revenue potential for Sunosi? A: The estimated peak revenue potential for Sunosi is greater than $1 billion, considering its current and potential new indications.

Sources

1. Sleep Review Magazine: "Wake-Promoting Sunosi 'Continues to Grow Adoption' with 4,000+ Prescriptions in Q2 2024"
2. Investing.com: "Earnings call: Axsome Therapeutics reports solid growth in 2023"
3. GlobeNewswire: "Axsome Therapeutics to Acquire Sunosi from Jazz Pharmaceuticals"
4. Nasdaq: "Will Auvelity & Sunosi Fuel Axsome's Growth Amid Stiff Competition?"
5. Synapse by Patsnap: "Axsome Therapeutics Q1 2024 Financial Results and Business Update"