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Last Updated: December 23, 2024

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SUNOSI Drug Patent Profile


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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

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Drug patent expirations by year for SUNOSI
Drug Prices for SUNOSI

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SUNOSI
Generic Entry Date for SUNOSI*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Johns Hopkins UniversityPhase 2
National Multiple Sclerosis SocietyPhase 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 thirty-six US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SUNOSI is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 17324855
Patent: Formulations of ( R)-2-amino-3-phenylpropyl carbamate
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 36068
Patent: FORMULATIONS DE (R)-2-AMINO-3-PHENYLPROPYL-CARBAMATE (FORMULATIONS OF (R)-2-AMINO-3-PHENYLPROPYL CARBAMATE)
Estimated Expiration: ⤷  Subscribe

Chile

Patent: 19000571
Patent: Formulaciones de carbamato de (r) -2-amino-3-fenilpropilo.
Estimated Expiration: ⤷  Subscribe

China

Patent: 9906078
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 09581
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 09581
Patent: FORMULATIONS DE (R (FORMULATIONS OF (R)
Estimated Expiration: ⤷  Subscribe

Finland

Patent: 09581
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 5193
Patent: פורמולות של (r) -2- אמינו - 3- פאנילפרופיל קארבאמאט (Formulations of (r)-2-amino-3-phenylpropyl carbamate)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 48498
Estimated Expiration: ⤷  Subscribe

Patent: 19533640
Patent: (R)−2−アミノ−3−フェニルプロピルカルバメートの製剤
Estimated Expiration: ⤷  Subscribe

Malaysia

Patent: 7631
Patent: FORMULATIONS OF (R)-2-AMINO-3-PHENYLPROPYL CARBAMATE
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 19002606
Patent: FORMULACIONES DE (R)-2-AMINO-3-FENILPROPIL CARBAMATO. (FORMULATIONS OF ( R)-2-AMINO-3-PHENYLPROPYL CARBAMATE.)
Estimated Expiration: ⤷  Subscribe

Philippines

Patent: 019500494
Patent: FORMULATIONS OF (R)-2-AMINO-3-PHENYLPROPYL CARBAMATE
Estimated Expiration: ⤷  Subscribe

Russian Federation

Patent: 64576
Patent: СОСТАВЫ (R)-2-АМИНО-3-ФЕНИЛПРОПИЛКАРБАМАТА ((R)-2-AMINO-3-PHENYLPROPYL CARBAMATE FORMULAS)
Estimated Expiration: ⤷  Subscribe

Patent: 19110127
Patent: СОСТАВЫ (R)-2-АМИНО-3-ФЕНИЛПРОПИЛ КАРБАМАТА
Estimated Expiration: ⤷  Subscribe

Saudi Arabia

Patent: 9401246
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 201901996U
Patent: FORMULATIONS OF ( R)-2-AMINO-3-PHENYLPROPYL CARBAMATE
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 2464646
Estimated Expiration: ⤷  Subscribe

Patent: 190104510
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 37795
Estimated Expiration: ⤷  Subscribe

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
Brazil 112019025286 métodos e composições para tratamento de sonolência excessiva ⤷  Subscribe
Philippines 12019502723 METHODS AND COMPOSITIONS FOR TREATING EXCESSIVE SLEEPINESS ⤷  Subscribe
Denmark 3509582 ⤷  Subscribe
Israel 265193 פורמולות של (r) -2- אמינו - 3- פאנילפרופיל קארבאמאט (Formulations of (r)-2-amino-3-phenylpropyl carbamate) ⤷  Subscribe
Mexico 2019002606 FORMULACIONES DE (R)-2-AMINO-3-FENILPROPIL CARBAMATO. (FORMULATIONS OF ( R)-2-AMINO-3-PHENYLPROPYL CARBAMATE.) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SUNOSI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1890684 2090011-4 Sweden ⤷  Subscribe PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF, PREFERABLY A HYDROCHLORIDE SALT THEROF; REG. NO/DATE: EU/1/19/1408 20200120
1890684 SPC/GB20/017 United Kingdom ⤷  Subscribe 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 CA 2020 00016 Denmark ⤷  Subscribe PRODUCT NAME: SOLRIAMFETOL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, FORTRINSVIST ET HYDROCHLORIDSALT DERAF; REG. NO/DATE: EU/1/19/1408 20200120
1890684 122020000015 Germany ⤷  Subscribe PRODUCT NAME: SOLRIAMFETOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, BEVORZUGT EIN HYDROCHLORIDSALZ DAVON.; REGISTRATION NO/DATE: EU/1/19/1408 20200116
1890684 C01890684/01 Switzerland ⤷  Subscribe PRODUCT NAME: SOLRIAMFETOLUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68177 22.03.2022
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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"

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