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Last Updated: June 16, 2025

Axsome Malta Company Profile


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Summary for Axsome Malta
International Patents:71
US Patents:39
Tradenames:1
Ingredients:1
NDAs:1

Drugs and US Patents for Axsome Malta

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 12,064,411 ⤷  Try for Free ⤷  Try for Free
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes 9,604,917 ⤷  Try for Free ⤷  Try for Free
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No 10,912,754 ⤷  Try for Free ⤷  Try for Free
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No 11,839,599 ⤷  Try for Free ⤷  Try for Free
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes 10,351,517 ⤷  Try for Free ⤷  Try for Free
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No 11,857,528 ⤷  Try for Free ⤷  Try for Free
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No 10,512,609 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for Axsome Malta Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1890684 132020000000040 Italy ⤷  Try for Free 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 2020/012 Ireland ⤷  Try for Free PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY A HYDROCHLORIDE SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1408 20200120
1890684 122020000015 Germany ⤷  Try for Free PRODUCT NAME: SOLRIAMFETOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, BEVORZUGT EIN HYDROCHLORIDSALZ DAVON.; REGISTRATION NO/DATE: EU/1/19/1408 20200116
1890684 CA 2020 00016 Denmark ⤷  Try for Free PRODUCT NAME: SOLRIAMFETOL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, FORTRINSVIST ET HYDROCHLORIDSALT DERAF; REG. NO/DATE: EU/1/19/1408 20200120
1890684 C202030015 Spain ⤷  Try for Free 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 20C1014 France ⤷  Try for Free 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 14/2020 Austria ⤷  Try for Free PRODUCT NAME: SOLRIAMFETOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, VORZUGSWEISE EIN HYDROCHLORIDSALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1408 (MITTEILUNG) 20200120
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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Pharmaceutical Competitive Landscape Analysis: Axsome Malta – Market Position, Strengths & Strategic Insights

Introduction

In the dynamic world of pharmaceuticals, Axsome Therapeutics has emerged as a notable player, with its subsidiary Axsome Malta playing a crucial role in the company's global strategy. This article delves into the competitive landscape surrounding Axsome Malta, examining its market position, strengths, and strategic insights that shape its operations in the pharmaceutical industry.

Axsome Malta: An Overview

Axsome Malta, a subsidiary of Axsome Therapeutics Inc., is a key component of the company's international operations. Located in Malta, this division leverages the country's strategic position and favorable business environment to contribute significantly to Axsome's global pharmaceutical endeavors.

Market Position

Global Reach from a Strategic Location

Axsome Malta's location in Malta provides a unique advantage for the company's European and North African operations. The island's position in the Mediterranean offers easy access to these markets, allowing Axsome to efficiently manage its distribution and regulatory affairs across multiple regions[3].

Specialization in CNS Disorders

Axsome Therapeutics, including its Malta subsidiary, focuses primarily on developing novel therapies for central nervous system (CNS) conditions. This specialization has allowed the company to carve out a niche in a highly competitive market[1].

Product Portfolio

Axsome's product portfolio, supported by its Malta operations, includes:

  1. Auvelity (dextromethorphan-bupropion) for major depressive disorder
  2. Sunosi (solriamfetol) for excessive daytime sleepiness
  3. Pipeline products targeting resistant depression, smoking cessation, and Alzheimer's disease agitation[1]

Strengths and Competitive Advantages

Innovative Research and Development

Axsome's strength lies in its innovative approach to drug development. The company's focus on novel therapies for CNS disorders with limited treatment options sets it apart from competitors[8].

Strong Clinical Trial Results

Axsome has demonstrated success in clinical trials, particularly with its lead candidates. These positive results have bolstered investor confidence and market credibility[6].

"In July 2023, Axsome announced positive results from the Phase 3 trial of AXS-05 in treating major depressive disorder, with a p-value < 0.001, demonstrating significant improvement over placebo."[6]

Experienced Management Team

The company benefits from a leadership team with extensive experience in drug development, commercialization, and regulatory affairs. This expertise is crucial for navigating the complex pharmaceutical landscape[4].

Strategic Partnerships

Axsome has established valuable partnerships that enhance its research capabilities and market access. For instance, the collaboration with Teva Pharmaceuticals for the distribution of AXS-07 demonstrates the company's strategy to leverage external expertise for expanded market reach[6].

Financial Position and Growth

Revenue Growth

Axsome has shown impressive revenue growth, with total revenue increasing from $126.4 million in 2022 to $219.7 million in 2023[6].

Strong Cash Position

As of the end of Q3 2023, Axsome reported a cash position of $282 million, providing adequate funding for ongoing research and development initiatives[6].

Regulatory Environment and Compliance

EU Membership Advantage

Malta's membership in the European Union provides Axsome Malta with access to the EU's regulatory framework, facilitating easier market entry for its products across Europe[3].

Bolar Exemption

Malta's implementation of the Bolar Exemption allows generic pharmaceutical companies to conduct necessary studies and trials before patent expiration, potentially benefiting Axsome's generic drug development efforts[3].

Manufacturing and Production Capabilities

State-of-the-Art Facilities

Axsome Malta likely benefits from Malta's investment in pharmaceutical infrastructure, including the €20 million Life Sciences Park[3].

Quality Standards

The company adheres to stringent quality standards, aligning with Malta's reputation for high-quality pharmaceutical manufacturing[3].

Market Challenges and Competition

Intense Competition

Axsome faces competition from established pharmaceutical giants like Eli Lilly, Pfizer, and AbbVie in the CNS drug market[4].

Market Share Limitations

A recent market analysis indicates that Axsome Therapeutics has less than 5% of the market share in the CNS drug segment, highlighting the need for continued growth and market penetration[10].

Strategic Insights and Future Prospects

Expansion of Product Pipeline

Axsome's strategy includes expanding its product pipeline, with ongoing clinical trials for various CNS disorders[1].

Geographical Expansion

Leveraging Malta's strategic location, Axsome is well-positioned to expand its presence in European and North African markets[3].

Focus on Unmet Medical Needs

The company's continued focus on developing therapies for conditions with limited treatment options presents significant growth opportunities[8].

Intellectual Property and Patent Strategy

Robust Patent Portfolio

Axsome's strong patent portfolio, including those related to its Malta operations, provides a competitive edge and protects its innovations[2].

Patent Litigation Success

Recent legal victories, such as the dismissal of patent litigation against Sandoz Inc., demonstrate Axsome's ability to defend its intellectual property rights[2].

Talent Acquisition and Retention

Skilled Workforce

Malta's emphasis on life sciences education and training provides Axsome Malta with access to a skilled workforce[3].

Collaborative Academic Partnerships

Partnerships with local educational institutions ensure a steady pipeline of talent for Axsome's Malta operations[3].

Environmental, Social, and Governance (ESG) Initiatives

Sustainability Efforts

While specific information on Axsome Malta's ESG initiatives is limited, the pharmaceutical industry's increasing focus on sustainability likely influences the company's operations.

Corporate Social Responsibility

Axsome's commitment to developing therapies for underserved medical conditions aligns with broader social responsibility goals in the pharmaceutical sector.

Key Takeaways

  1. Axsome Malta plays a crucial role in Axsome Therapeutics' global strategy, leveraging Malta's strategic location and favorable business environment.
  2. The company's focus on CNS disorders and innovative drug development sets it apart in a competitive market.
  3. Strong clinical trial results and a robust product pipeline contribute to Axsome's market credibility and growth potential.
  4. Strategic partnerships and an experienced management team enhance the company's competitive position.
  5. While facing challenges from established competitors, Axsome's niche focus and expanding product portfolio present significant opportunities for future growth.

FAQs

  1. What is Axsome Malta's primary focus in the pharmaceutical industry? Axsome Malta, as part of Axsome Therapeutics, primarily focuses on developing novel therapies for central nervous system (CNS) disorders, including depression, Alzheimer's disease agitation, and migraine.

  2. How does Malta's location benefit Axsome's operations? Malta's strategic position in the Mediterranean provides Axsome with easy access to European and North African markets, facilitating efficient distribution and regulatory management across these regions.

  3. What are some of Axsome's key products? Axsome's key products include Auvelity for major depressive disorder and Sunosi for excessive daytime sleepiness, along with several pipeline products targeting various CNS conditions.

  4. How does Axsome's financial position support its growth strategy? As of Q3 2023, Axsome reported a strong cash position of $282 million, providing adequate funding for ongoing research and development initiatives, which is crucial for its growth strategy in developing new therapies.

  5. What competitive advantages does Axsome have in the pharmaceutical market? Axsome's competitive advantages include its innovative approach to drug development, strong clinical trial results, experienced management team, strategic partnerships, and focus on underserved medical conditions in the CNS field.

Sources cited: [1] https://www.globaldata.com/company-profile/axsome-therapeutics-inc/ [2] https://markets.businessinsider.com/news/stocks/buy-rating-on-axsome-therapeutics-legal-wins-and-positive-clinical-trial-outlook-secure-market-position-1033714743 [3] https://www.pharmexec.com/view/malta-healthy-location-pharmaceutical-industry [4] https://pitchgrade.com/companies/axsome-therapeutics-inc [6] https://canvasbusinessmodel.com/products/axsome-therapeutics-swot-analysis [8] https://canvasbusinessmodel.com/blogs/growth-strategy/axsome-therapeutics-growth-strategy [10] https://canvasbusinessmodel.com/products/axsome-therapeutics-swot-analysis

Last updated: 2025-02-14

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