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Last Updated: June 20, 2025

Mallinckrodt Inc Company Profile


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Summary for Mallinckrodt Inc
International Patents:31
US Patents:12
Tradenames:4
Ingredients:4
NDAs:4
Drug Master File Entries: 67
Patent Litigation for Mallinckrodt Inc: See patent lawsuits for Mallinckrodt Inc

Drugs and US Patents for Mallinckrodt Inc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt Inc HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate SOLUTION;ORAL 040508-001 Aug 29, 2003 DISCN No No ⤷  Try for Free ⤷  Try for Free
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No 7,976,870 ⤷  Try for Free ⤷  Try for Free
Mallinckrodt Inc METHADONE HYDROCHLORIDE methadone hydrochloride POWDER;FOR RX COMPOUNDING 006383-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No 8,992,975 ⤷  Try for Free Y ⤷  Try for Free
Mallinckrodt Inc METHADONE HYDROCHLORIDE methadone hydrochloride POWDER;FOR RX COMPOUNDING 006383-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free
Mallinckrodt Inc METHADONE HYDROCHLORIDE methadone hydrochloride POWDER;FOR RX COMPOUNDING 006383-002 Approved Prior to Jan 1, 1982 DISCN 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
Paragraph IV (Patent) Challenges for MALLINCKRODT INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 7.5 mg/325 mg ➤ Subscribe 2014-04-03
Premature patent expirations for MALLINCKRODT INC

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
⤷  Try for Free ⤷  Try for Free

Supplementary Protection Certificates for Mallinckrodt Inc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2465580 SPC/GB21/030 United Kingdom ⤷  Try for Free PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
2666774 CA 2020 00037 Denmark ⤷  Try for Free PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
0473687 SPC/GB98/030 United Kingdom ⤷  Try for Free PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
2822954 SPC/GB18/031 United Kingdom ⤷  Try for Free PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625
0268956 1999C0030 Belgium ⤷  Try for Free PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
1758590 LUC00029 Luxembourg ⤷  Try for Free PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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Pharmaceutical Competitive Landscape Analysis: Mallinckrodt Inc – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, Mallinckrodt Inc stands as a notable player with a rich history and a diverse portfolio. Let's dive into a comprehensive analysis of Mallinckrodt's market position, strengths, and strategic insights to understand its competitive landscape better.

Company Overview

Mallinckrodt Pharmaceuticals is a multibillion-dollar specialty pharmaceutical company with a mission focused on "Listening for needs. Delivering solutions."[7] With a history spanning over 150 years, the company has established itself as a significant player in the pharmaceutical industry, particularly in the areas of specialty brands and specialty generics.

Key Business Segments

Mallinckrodt operates through two main business segments:

  1. Specialty Brands: This segment focuses on innovative therapies for autoimmune and rare diseases, immunotherapy, neonatal respiratory critical care, and analgesics and gastrointestinal products[7].

  2. Specialty Generics: This segment produces and distributes specialty generic pharmaceuticals and active pharmaceutical ingredients (APIs)[1].

Market Position

Mallinckrodt has carved out a significant position in the pharmaceutical market, particularly in the United States. In 2017, the company generated 90% of its sales from the U.S. healthcare system, with net sales of $3.2 billion[2]. However, recent years have seen some challenges and changes in the company's market position.

Specialty Generics Segment Performance

The Specialty Generics segment has shown strong performance in recent years. In fiscal 2023, this segment reported year-over-year net sales growth of 20.5%[1]. This growth was driven by:

  • Strong performance in the finished-dosage products business
  • Manufacturing excellence in the Acetaminophen (APAP) business
  • Successful launches of new products, including generic versions of Mydayis® and Vyvanse® capsules for ADHD, and morphine sulfate tablets

Specialty Brands Segment Challenges

While the Specialty Generics segment has shown growth, the Specialty Brands segment has faced some challenges. For instance, in the second quarter of 2023, Acthar Gel, one of the company's key products, saw a 4.0% decline in net sales[10].

Strengths and Competitive Advantages

Despite facing challenges, Mallinckrodt possesses several strengths that contribute to its competitive position in the pharmaceutical market.

1. Vertical Integration in Specialty Generics

Mallinckrodt's Specialty Generics business is vertically integrated, which provides several advantages:

  • Reliable and consistent supply chain
  • Stable pricing dynamics
  • Competitive advantage with customers, especially during supply chain constraints[1]

2. Strong R&D Capabilities

The company has a robust Research & Development (R&D) organization focusing on various therapeutic areas, including:

  • Neurology
  • Rheumatology
  • Hepatology
  • Nephrology
  • Pulmonology
  • Ophthalmology
  • Oncology[3]

This diverse R&D focus allows Mallinckrodt to develop innovative solutions across multiple medical fields.

3. Product Portfolio Diversity

Mallinckrodt's product portfolio spans a wide range of therapeutic areas, including:

  • Pain management products
  • Contrast agents for diagnostic imaging
  • Respiratory treatments
  • Specialty generics[2]

This diversity helps mitigate risks associated with reliance on a single product or therapeutic area.

"We are pleased with the meaningful progress we made in 2023 as we exceeded the high end of our annual net sales and Adjusted EBITDA guidance."[4]

4. Manufacturing Excellence

The company's manufacturing capabilities, particularly in the Acetaminophen (APAP) business, have contributed to its strong performance in the Specialty Generics segment[1].

Strategic Insights

To maintain and improve its competitive position, Mallinckrodt has implemented several strategic initiatives.

1. Focus on New Product Launches

Mallinckrodt has been actively launching new products to drive growth. In 2023, the company successfully launched three new products in its Specialty Generics segment, including generic versions of popular ADHD medications[1].

2. Regulatory Approvals and Product Development

The company continues to invest in product development and seek regulatory approvals. For example:

  • In Q4 2023, Mallinckrodt gained regulatory approval for a reformulation of its fentanyl patch product[1].
  • The company received FDA clearance for the INOmax® EVOLVE™ DS Delivery System, with rollout planned for 2024[4].

3. Market Expansion for Existing Products

Mallinckrodt is working on expanding the market for its existing products. For instance, the company is planning to launch Acthar® Gel Single-Dose Pre-filled SelfJect™ Injector in 2024, potentially expanding the product's reach[4].

4. Strategic Pricing

While controversial, Mallinckrodt's pricing strategy for certain products, such as Acthar gel, has significantly impacted its revenue. The price of Acthar gel increased from $40 a vial in 2001 to $34,000 in 2014[2]. However, this strategy has also led to legal challenges and public scrutiny.

Challenges and Threats

Despite its strengths, Mallinckrodt faces several challenges and threats in the competitive pharmaceutical landscape.

1. Legal and Regulatory Issues

Mallinckrodt has faced legal challenges related to its pricing practices and alleged anti-competitive behavior. In 2017, the company settled a lawsuit with the Federal Trade Commission and five state attorneys general, agreeing to pay $100 million and license a competing product[2].

2. Opioid Crisis Involvement

The company has been implicated as a major contributor to the prescription opioid crisis in the United States[2]. This involvement has led to legal challenges and reputational damage.

3. Intense Competition

Mallinckrodt operates in a highly competitive market with both established pharmaceutical giants and emerging biotech firms. Competitors include:

  • Purdue Pharma
  • Horizon Therapeutics
  • Amgen
  • Eli Lilly[9]

4. Market Volatility

The pharmaceutical market is subject to rapid changes due to factors such as regulatory changes, patent expirations, and emerging technologies. This volatility can impact Mallinckrodt's market position and financial performance.

Future Outlook

Despite the challenges, Mallinckrodt's future outlook shows potential for growth and improvement.

1. Specialty Generics Growth

The company expects continued sales growth in the Specialty Generics segment throughout the year, positioning Mallinckrodt as an important source of consistent supply and high-quality products[10].

2. New Product Potential

The launch of new products, such as Terlivaz, shows promise. Based on early utilization data, the company expects peak year net sales for Terlivaz to be between $100-$200 million[10].

3. Market Expansion

Mallinckrodt is actively working on expanding its market presence. For instance, the company has gained formulary inclusion for Terlivaz at approximately 50% of targeted hospitals, ahead of the product's anticipated launch curve[10].

Key Takeaways

  1. Mallinckrodt Inc is a significant player in the pharmaceutical industry, with a strong presence in specialty brands and specialty generics.

  2. The company's Specialty Generics segment has shown strong growth, driven by new product launches and manufacturing excellence.

  3. Mallinckrodt faces challenges in its Specialty Brands segment and legal issues related to pricing and opioid crisis involvement.

  4. The company's strengths include vertical integration in Specialty Generics, strong R&D capabilities, and a diverse product portfolio.

  5. Future growth potential lies in continued expansion of the Specialty Generics segment and successful launches of new products.

FAQs

  1. Q: What are Mallinckrodt's main business segments? A: Mallinckrodt operates through two main segments: Specialty Brands and Specialty Generics.

  2. Q: How has Mallinckrodt's Specialty Generics segment performed recently? A: The Specialty Generics segment reported year-over-year net sales growth of 20.5% in fiscal 2023.

  3. Q: What are some of Mallinckrodt's key strengths? A: Key strengths include vertical integration in Specialty Generics, strong R&D capabilities, and a diverse product portfolio.

  4. Q: What challenges does Mallinckrodt face? A: Challenges include legal and regulatory issues, involvement in the opioid crisis, intense competition, and market volatility.

  5. Q: What is Mallinckrodt's strategy for future growth? A: Mallinckrodt is focusing on new product launches, regulatory approvals, market expansion for existing products, and continued growth in the Specialty Generics segment.

Sources cited: [1] https://www.mallinckrodt.com/about/news-and-media/news-detail/?id=30856 [2] https://en.wikipedia.org/wiki/Mallinckrodt [3] https://www.mallinckrodt.com/research/ [4] https://ir.mallinckrodt.com/news-releases/news-release-details/mallinckrodt-plc-reports-fourth-quarter-and-fiscal-year-2023 [7] https://www.mallinckrodt.com/about/ [9] https://pitchgrade.com/companies/collegium-pharmaceutical-inc [10] https://www.mallinckrodt.com/about/news-and-media/news-detail/?id=30126

Last updated: 2025-02-14

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