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Last Updated: June 18, 2025

Aucta Company Profile


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Summary for Aucta
International Patents:6
US Patents:3
Tradenames:5
Ingredients:5
NDAs:5

Drugs and US Patents for Aucta

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aucta ARFORMOTEROL TARTRATE arformoterol tartrate SOLUTION;INHALATION 218380-001 Feb 3, 2025 AN RX No No ⤷  Try for Free ⤷  Try for Free
Aucta MOTPOLY XR lacosamide CAPSULE, EXTENDED RELEASE;ORAL 216185-002 May 4, 2023 RX Yes No 11,337,943 ⤷  Try for Free Y ⤷  Try for Free
Aucta MOTPOLY XR lacosamide CAPSULE, EXTENDED RELEASE;ORAL 216185-001 May 4, 2023 RX Yes No 11,337,943 ⤷  Try for Free Y ⤷  Try for Free
Aucta MOTPOLY XR lacosamide CAPSULE, EXTENDED RELEASE;ORAL 216185-003 May 4, 2023 RX Yes Yes 11,883,374 ⤷  Try for Free Y ⤷  Try for Free
Aucta MOTPOLY XR lacosamide CAPSULE, EXTENDED RELEASE;ORAL 216185-003 May 4, 2023 RX Yes Yes 12,042,474 ⤷  Try for Free Y ⤷  Try for Free
Aucta VIGADRONE vigabatrin FOR SOLUTION;ORAL 210196-001 Jun 21, 2018 AA RX No No ⤷  Try for Free ⤷  Try for Free
Aucta DEFERASIROX deferasirox GRANULE;ORAL 214559-002 Mar 9, 2021 AB RX No No ⤷  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 Aucta Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0888289 C300376 Netherlands ⤷  Try for Free PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829
0914118 C00914118/01 Switzerland ⤷  Try for Free PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005
0914118 PA2007001 Lithuania ⤷  Try for Free PRODUCT NAME: DEFERASIROXUM; REGISTRATION NO/DATE: EU/1/06/356/001 2006 08 28, EU/1/06/356/002 2006 08 28, EU/1/06/356/003 2006 08 28, EU/1/06/356/004 2006 08 28, EU/1/06/356/005 2006 08 28, EU/1/06/356/00 20060828
0888289 09C0006 France ⤷  Try for Free PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/08/470/001 DU 20080829; REGISTRATION NO/DATE AT EEC: EU/1/08/470/001 DU 20080829
0914118 SPC/GB07/002 United Kingdom ⤷  Try for Free SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/002 GRANTED TO NOVARTIS AG IN RESPECT OF THE PRODUCT DEFERASIROX AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY 4-(3,5-BIS(2-HYDROXYPHENYL)-(1,2,4) TRIAZOL-L-YL) BENZOIC ACID, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6179 DATED 24 OCTOBER 2007 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 30 AUGUST 2021.
0914118 PA2007001,C0914118 Lithuania ⤷  Try for Free PRODUCT NAME: DEFERASIROXUM; REGISTRATION NO/DATE: EU/1/06/356/001 2006-08-28, EU/1/06/356/002 2006-08-28, EU/1/06/356/003 2006-08-28, EU/1/06/356/004 2006-08-28, EU/1/06/356/005 2006-08-28, EU/1/06/356/00 20060828
0914118 06C0049 France ⤷  Try for Free PRODUCT NAME: DEFERASIROX OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/06/356/001 DU 20060828; REGISTRATION NO/DATE AT EEC: EU/1/06/356/001 DU 20060828
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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Pharmaceutical Competitive Landscape Analysis: Aucta – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, understanding the competitive landscape is crucial for companies to thrive and innovate. This analysis focuses on Aucta Pharmaceuticals, a rising player in the pharmaceutical sector, examining its market position, strengths, and strategic insights. By delving into Aucta's operations and comparing them with industry trends, we can gain valuable insights into the company's potential and challenges in the current pharmaceutical market.

Aucta Pharmaceuticals: An Overview

Aucta Pharmaceuticals, Inc. is an emerging technology-based pharmaceutical company that has been making waves in the industry. Founded in 2012, Aucta has operations in both New Jersey, U.S., and Shanghai, China[1][7]. The company's name, derived from the Latin word for "enhanced" or "improved," reflects its core mission of creating better products from proven molecules.

Business Model and Focus Areas

Aucta's business model is centered around the development and commercialization of specialty brand and specialty generic products. The company employs a hybrid approach, combining elements of both branded and generic pharmaceutical strategies[5].

Key Focus Areas:

  1. CNS (Central Nervous System) disorders
  2. Orphan indications
  3. Ophthalmology
  4. Inhalation therapies

Aucta's strategic focus on these therapeutic areas allows it to target niche markets with high unmet medical needs, potentially leading to significant market opportunities.

Innovative Approach: The 505(b)(2) Regulatory Pathway

One of Aucta's key strategies is leveraging the 505(b)(2) regulatory pathway for drug development[1]. This approach allows the company to:

  1. Develop new formulations of existing drugs
  2. Create new dosage forms
  3. Explore new indications for proven molecules

By utilizing this pathway, Aucta can potentially bring improved therapies to market faster and with lower development costs compared to traditional drug development methods.

Technology Platforms and Product Development

Aucta's commitment to innovation is evident in its technology platforms, which include:

  1. Pediatric formulations
  2. Controlled release systems
  3. Novel delivery systems

These platforms enable Aucta to create patient-centric products that address specific needs in their target therapeutic areas.

"Through innovation, Aucta is creating new therapeutics, including new dosage forms, new dosing regimens, and new indications."[1]

Market Position and Recent Developments

Aucta has been steadily strengthening its market position, with a significant milestone achieved in early 2024:

Motpoly XR Launch

In mid-February 2024, Aucta successfully launched its first branded product, Motpoly XR, in the epilepsy space[5]. This launch marks Aucta's entry into the competitive neurology market and demonstrates the company's ability to bring innovative products to market.

Expansion Plans

Following the successful launch of Motpoly XR, Aucta is now expanding its commercial presence in the neurology/epilepsy sector. The company plans to increase its field sales territories to 20, indicating a strong commitment to growth and market penetration[5].

Strengths and Competitive Advantages

1. Innovative Product Development

Aucta's focus on improving existing molecules through novel formulations and delivery systems sets it apart from traditional pharmaceutical companies. This approach allows for potentially faster development times and lower risks compared to developing entirely new chemical entities.

2. Targeted Therapeutic Focus

By concentrating on specific therapeutic areas like CNS disorders and orphan indications, Aucta can develop deep expertise and build strong relationships with healthcare providers in these niches.

3. Hybrid Business Model

The combination of branded and generic strategies allows Aucta to generate near-term revenue from generic products while investing in longer-term, higher-value branded products.

4. Global Presence

With operations in both the United States and China, Aucta is well-positioned to tap into two of the world's largest pharmaceutical markets.

5. Regulatory Expertise

Aucta's proficiency in navigating the 505(b)(2) regulatory pathway gives it a competitive edge in bringing improved formulations to market efficiently.

Strategic Insights and Future Outlook

Expanding Product Pipeline

Aucta's success with Motpoly XR is likely to pave the way for future product launches. The company's focus on enhancing its marketing, managed care, and sales capabilities suggests a strong pipeline of products in development[5].

Market Expansion Opportunities

As Aucta continues to grow, it may explore opportunities to expand into additional therapeutic areas or geographic markets. The company's experience in both the U.S. and Chinese markets could be leveraged for further international expansion.

Potential for Strategic Partnerships

Given Aucta's innovative approach and growing market presence, the company may become an attractive partner for larger pharmaceutical companies looking to bolster their pipelines or enter niche markets.

Challenges and Competition

Patent Expirations and Generic Competition

Like all pharmaceutical companies, Aucta must navigate the challenges of patent expirations and potential generic competition for its branded products.

Regulatory Hurdles

The complex and ever-changing regulatory landscape in the pharmaceutical industry poses ongoing challenges, particularly as Aucta expands its product portfolio and enters new markets.

Intense Competition

Aucta faces competition from both established pharmaceutical giants and other emerging biotech companies. Key competitors in the broader pharmaceutical landscape include:

  1. Roche
  2. Pfizer
  3. Johnson & Johnson
  4. Novartis
  5. Merck & Co.[6]

While these companies may not directly compete with Aucta in all therapeutic areas, their significant resources and market presence pose a competitive challenge.

Financial Outlook and Investment Potential

As a privately held company, detailed financial information for Aucta is not publicly available. However, the company's recent product launch and expansion plans suggest a positive growth trajectory. Potential investors and industry analysts should consider the following factors:

  1. Revenue potential from Motpoly XR and future product launches
  2. R&D investment and pipeline strength
  3. Market penetration in target therapeutic areas
  4. Potential for strategic partnerships or acquisitions

Industry Trends and Aucta's Positioning

Focus on Patient-Centric Solutions

Aucta's commitment to developing improved formulations and delivery systems aligns well with the industry-wide trend towards more patient-centric healthcare solutions.

Rise of Specialty Pharmaceuticals

The growing importance of specialty drugs in the pharmaceutical market plays to Aucta's strengths, given its focus on niche therapeutic areas and innovative formulations.

Increasing Demand for CNS Therapies

With CNS disorders as one of its key focus areas, Aucta is well-positioned to capitalize on the growing demand for neurological and psychiatric treatments.

Aucta's Role in Addressing Unmet Medical Needs

Aucta's focus on orphan indications and improved formulations of existing drugs demonstrates its commitment to addressing unmet medical needs. This approach not only serves patients but also aligns with regulatory incentives for developing treatments for rare diseases.

Talent Acquisition and Company Culture

Aucta's growth and success will depend heavily on its ability to attract and retain top talent in the pharmaceutical industry. The company's job postings emphasize:

  1. A fast-growing environment
  2. Opportunities for career growth
  3. Competitive compensation and benefits[8]

These factors suggest that Aucta is positioning itself as an attractive employer in the competitive pharmaceutical job market.

Key Takeaways

  1. Aucta Pharmaceuticals is an emerging player in the pharmaceutical industry, focusing on specialty brand and generic products.
  2. The company's innovative use of the 505(b)(2) regulatory pathway allows for efficient development of improved formulations.
  3. Aucta's recent launch of Motpoly XR marks its entry into the branded product market, with plans for expansion in the neurology sector.
  4. Key strengths include a targeted therapeutic focus, hybrid business model, and global presence.
  5. Challenges include navigating patent expirations, regulatory hurdles, and competition from established pharmaceutical giants.
  6. Aucta's focus on patient-centric solutions and specialty pharmaceuticals aligns well with current industry trends.
  7. The company's commitment to addressing unmet medical needs, particularly in CNS disorders and orphan indications, positions it for potential growth in these areas.

As Aucta Pharmaceuticals continues to evolve and expand its presence in the pharmaceutical market, it will be an interesting company to watch for industry professionals, investors, and healthcare providers alike. Its innovative approach to drug development and targeted therapeutic focus could potentially disrupt traditional pharmaceutical business models and bring much-needed improvements to patient care.

FAQs

  1. What is Aucta Pharmaceuticals' primary business model? Aucta employs a hybrid model, focusing on both specialty brand and specialty generic products, with an emphasis on improving existing molecules through innovative formulations and delivery systems.

  2. How does Aucta's use of the 505(b)(2) regulatory pathway benefit the company? The 505(b)(2) pathway allows Aucta to develop new formulations of existing drugs more efficiently, potentially reducing development time and costs compared to traditional drug development methods.

  3. What are Aucta's main therapeutic focus areas? Aucta primarily focuses on CNS disorders, orphan indications, ophthalmology, and inhalation therapies.

  4. How does Aucta's recent product launch, Motpoly XR, impact its market position? The successful launch of Motpoly XR in the epilepsy space marks Aucta's entry into the branded product market and demonstrates its ability to bring innovative products to market, potentially paving the way for future growth and expansion.

  5. What are the key challenges Aucta faces in the pharmaceutical industry? Major challenges include navigating patent expirations, addressing regulatory hurdles, and competing with established pharmaceutical giants and other emerging biotech companies in a rapidly evolving market landscape.

Sources cited:

  1. https://www.auctapharma.com/about.html
  2. https://www.auctapharma.com/AuctaShow/44.html
  3. https://pitchgrade.com/companies/amgen
  4. https://www.drugs.com/manufacturer/aucta-pharmaceuticals-inc-659.html
  5. https://www.auctapharma.com/AuctaShow/50.html
Last updated: 2025-02-12

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