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Last Updated: March 13, 2025

Mallinckrodt Ireland Company Profile


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What is the competitive landscape for MALLINCKRODT IRELAND

MALLINCKRODT IRELAND has two approved drugs.

There are two US patents protecting MALLINCKRODT IRELAND drugs.

There are twenty-eight patent family members on MALLINCKRODT IRELAND drugs in seventeen countries.

Summary for Mallinckrodt Ireland
International Patents:28
US Patents:2
Tradenames:3
Ingredients:2
NDAs:2

Drugs and US Patents for Mallinckrodt Ireland

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Mallinckrodt Ireland ACTHAR GEL corticotropin INJECTABLE;INJECTION 008372-008 Approved Prior to Jan 1, 1982 RX Yes Yes 11,752,199 ⤷  Try for Free ⤷  Try for Free
Mallinckrodt Ireland ACTHAR GEL (AUTOINJECTOR) corticotropin INJECTABLE;INJECTION 008372-004 Feb 29, 2024 RX Yes Yes 11,752,199 ⤷  Try for Free ⤷  Try for Free
Mallinckrodt Ireland ACTHAR GEL (AUTOINJECTOR) corticotropin INJECTABLE;INJECTION 008372-003 Feb 29, 2024 RX Yes Yes 11,752,199 ⤷  Try for Free ⤷  Try for Free
Mallinckrodt Ireland TERLIVAZ terlipressin acetate POWDER;INTRAVENOUS 022231-001 Sep 14, 2022 RX Yes Yes 10,335,452 ⤷  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
Showing 1 to 4 of 4 entries
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Pharmaceutical Competitive Landscape Analysis: Mallinckrodt Ireland – Market Position, Strengths & Strategic Insights

Mallinckrodt Pharmaceuticals, a global specialty biopharmaceutical company, has maintained a significant presence in Ireland for over two decades. This analysis delves into Mallinckrodt's market position, strengths, and strategic insights within the Irish pharmaceutical landscape.

Mallinckrodt's Footprint in Ireland

Mallinckrodt has invested heavily in its Irish operations, demonstrating a long-term commitment to the country. In 2015, the company announced a €45 million investment to expand its Dublin-based operations, bringing its total investment in Ireland to more than €165 million over 22 years[1]. This substantial investment underscores Ireland's strategic importance to Mallinckrodt's global operations.

State-of-the-Art Manufacturing Facility

The 2015 investment included the establishment of a state-of-the-art manufacturing facility and office building at College Business and Technology Park in Blanchardstown, Dublin[1]. This expansion not only created jobs but also enhanced Mallinckrodt's manufacturing capabilities in Ireland.

Job Creation and Economic Impact

Mallinckrodt's expansion in Ireland has had a significant economic impact. The development provided 300 jobs during the two-year construction phase and created 45 skilled full-time positions upon completion[1]. As of 2015, Mallinckrodt employed more than 120 people at its existing manufacturing site and offices in Dublin[1].

Mallinckrodt's Market Position in Ireland

Mallinckrodt has positioned itself as a key player in the Irish pharmaceutical industry, focusing on specialty pharmaceutical products and therapies.

Therapeutic Focus Areas

The company provides treatment options for patients with a wide variety of health conditions, with a particular focus on:

  • Autoimmune and rare diseases
  • Analgesia
  • Neonatal critical care respiratory therapies
  • Central nervous system disorders[1]

Contribution to Ireland's Pharmaceutical Sector

Mallinckrodt's presence in Ireland contributes to the country's growing reputation as a medical innovation hub. As noted by An Tánaiste Joan Burton TD in 2015:

"The pharmaceutical industry is a key contributor to Ireland's economy and to Ireland's growing international reputation as a medical innovation hub."[1]

Mallinckrodt's Strengths in the Irish Market

Mallinckrodt's success in Ireland can be attributed to several key strengths:

1. Vertically Integrated Business Model

Mallinckrodt's vertically integrated business model has been a core strength, particularly in its Specialty Generics segment. This integration allows for better control over the supply chain and manufacturing processes[6].

2. Research and Development Capabilities

The company has been bringing global R&D activities for medical devices to its Irish location, focusing on developing systems for delivery of certain specialty pharmaceutical therapies in its portfolio[2].

3. Regulatory Expertise

Mallinckrodt's core strengths include deep regulatory expertise, which is crucial in the highly regulated pharmaceutical industry[7].

4. Specialized Chemistry and Manufacturing Capabilities

The company's specialized chemistry, formulation, and manufacturing capabilities set it apart in the market[7].

Strategic Insights and Future Outlook

Focus on Innovation

Mallinckrodt's strategic vision is to be an innovation-driven specialty pharmaceutical company focused on improving outcomes for patients with severe and critical conditions[3]. This focus on innovation is likely to drive future growth and market positioning.

Financial Restructuring

In November 2023, Mallinckrodt completed a financial restructuring process, reducing its total funded debt by approximately $1.9 billion[4]. This improved financial position is expected to provide increased flexibility for future investments and growth strategies.

Product Pipeline and Recent Approvals

Mallinckrodt's future growth in Ireland and globally will be supported by its product pipeline and recent regulatory approvals. For instance, in Q3 2023, the company received three FDA abbreviated new drug application approvals, including for lisdexamfetamine dimesylate capsules[6].

Market Expansion Opportunities

The Ireland Pharmaceutical Market is projected to reach US $xx Bn by 2030, exhibiting a CAGR of xx% during the forecast period[10]. This growth presents significant opportunities for Mallinckrodt to expand its market share in Ireland.

Challenges and Competition

Despite its strong position, Mallinckrodt faces challenges in the competitive Irish pharmaceutical landscape:

1. Regulatory Pressures

The pharmaceutical industry is highly regulated, and changes in regulations can impact Mallinckrodt's operations and product approvals.

2. Market Competition

Mallinckrodt competes with both local and global pharmaceutical companies in Ireland, necessitating continuous innovation and market differentiation.

3. Pricing Pressures

Like many pharmaceutical companies, Mallinckrodt may face pressures to reduce drug prices, which could impact profitability.

Corporate Social Responsibility

Mallinckrodt's commitment to corporate social responsibility in Ireland is evident through its investments in three strategic areas:

  1. Improving health and wellness
  2. Advancing science, technology, engineering, and mathematics (STEM)
  3. Strengthening communities[8]

These initiatives not only contribute to societal well-being but also enhance Mallinckrodt's reputation and stakeholder relationships in Ireland.

Key Takeaways

  • Mallinckrodt has a strong and long-standing presence in Ireland, with significant investments in manufacturing and R&D facilities.
  • The company's focus on specialty pharmaceuticals, particularly in areas like autoimmune and rare diseases, positions it well in the growing Irish pharmaceutical market.
  • Mallinckrodt's vertically integrated business model, regulatory expertise, and specialized manufacturing capabilities are key strengths in the competitive landscape.
  • Recent financial restructuring has improved the company's financial flexibility, potentially enabling future growth and investments.
  • Challenges include regulatory pressures, market competition, and potential pricing pressures.
  • Mallinckrodt's commitment to innovation and corporate social responsibility initiatives contribute to its positive standing in the Irish market.

FAQs

  1. Q: What is Mallinckrodt's main focus in the Irish pharmaceutical market? A: Mallinckrodt focuses on specialty pharmaceutical products and therapies, particularly in areas such as autoimmune and rare diseases, analgesia, neonatal critical care respiratory therapies, and central nervous system disorders.

  2. Q: How has Mallinckrodt contributed to job creation in Ireland? A: Mallinckrodt's 2015 expansion in Dublin created 300 jobs during construction and 45 skilled full-time positions upon completion. As of 2015, the company employed over 120 people at its existing manufacturing site and offices in Dublin.

  3. Q: What are some of Mallinckrodt's key strengths in the Irish market? A: Mallinckrodt's key strengths include its vertically integrated business model, research and development capabilities, regulatory expertise, and specialized chemistry and manufacturing capabilities.

  4. Q: How has Mallinckrodt's recent financial restructuring affected its position in Ireland? A: The financial restructuring completed in November 2023 reduced Mallinckrodt's total funded debt by approximately $1.9 billion, providing increased financial flexibility for future investments and growth strategies in Ireland and globally.

  5. Q: What are the main challenges Mallinckrodt faces in the Irish pharmaceutical market? A: The main challenges include regulatory pressures, market competition from both local and global pharmaceutical companies, and potential pricing pressures in the industry.

Sources cited: [1] https://www.mallinckrodt.com/about/news-and-media/news-detail/?id=7911 [2] https://www.mallinckrodt.com/about/news-and-media/news-detail/?id=8236 [3] https://www.mallinckrodt.com/about/ [4] https://ir.mallinckrodt.com/news-releases/news-release-details/mallinckrodt-completes-financial-restructuring-and-irish [6] https://mallinckrodt.gcs-web.com/news-releases/news-release-details/mallinckrodt-plc-examinership-reports-third-quarter-2023 [7] https://www.mnk.com/about/news-and-media/news-detail/?id=7911 [8] https://www.responsibilityreports.com/HostedData/ResponsibilityReportArchive/m/NYSE_MNK_2020.pdf [10] https://www.insights10.com/report/ireland-pharmaceutical-market-analysis/

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