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Last Updated: April 18, 2025

Mylan Institutional Company Profile


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What is the competitive landscape for MYLAN INSTITUTIONAL

MYLAN INSTITUTIONAL has thirty-three approved drugs.



Drugs and US Patents for Mylan Institutional

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Mylan Institutional BUSULFAN busulfan INJECTABLE;INJECTION 208536-001 Nov 20, 2017 AP RX No No ⤷  Try for Free ⤷  Try for Free
Mylan Institutional DURACLON clonidine hydrochloride INJECTABLE;INJECTION 020615-002 Apr 27, 1999 DISCN Yes No ⤷  Try for Free ⤷  Try for Free
Mylan Institutional NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 205014-001 Jun 29, 2016 AP RX No No ⤷  Try for Free ⤷  Try for Free
Mylan Institutional PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride INJECTABLE;INJECTION 040471-001 Nov 21, 2002 DISCN No No ⤷  Try for Free ⤷  Try for Free
Mylan Institutional ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 079199-002 Nov 26, 2008 AP RX No No ⤷  Try for Free ⤷  Try for Free
Mylan Institutional SOTRADECOL sodium tetradecyl sulfate INJECTABLE;INJECTION 040541-001 Nov 12, 2004 RX No Yes ⤷  Try for Free ⤷  Try for Free
Mylan Institutional THIAMINE HYDROCHLORIDE thiamine hydrochloride INJECTABLE;INJECTION 091623-001 Jun 25, 2012 AP 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
Showing 1 to 7 of 7 entries

Expired US Patents for Mylan Institutional

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Mylan Institutional RIMSO-50 dimethyl sulfoxide SOLUTION;INTRAVESICAL 017788-001 Approved Prior to Jan 1, 1982 3,549,770 ⤷  Try for Free
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-001 Jul 12, 1996 5,866,591*PED ⤷  Try for Free
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-002 Jul 12, 1996 5,019,583*PED ⤷  Try for Free
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-002 Jul 12, 1996 5,466,700*PED ⤷  Try for Free
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-001 Jul 12, 1996 5,019,583*PED ⤷  Try for Free
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-002 Jul 12, 1996 5,866,591*PED ⤷  Try for Free
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-003 Jul 12, 1996 5,866,591*PED ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 7 of 7 entries
Paragraph IV (Patent) Challenges for MYLAN INSTITUTIONAL drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe for Injection 1 mg/vial, 2 mg/vial and 5 mg/vial ➤ Subscribe 2013-12-27
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: Mylan Institutional – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, Mylan Institutional has emerged as a significant player, carving out a unique position for itself. This comprehensive analysis delves into Mylan Institutional's market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

Mylan Institutional: An Overview

Mylan Institutional, a subsidiary of Mylan N.V. (now part of Viatris), is a key player in the pharmaceutical industry, focusing on providing high-quality, affordable medications to institutional customers. The company's product portfolio spans a wide range of therapeutic areas, including injectable and unit dose offerings[6].

Historical Context

Mylan Institutional was created in 2010 by combining the product lines of Mylan Institutional LLC (formerly Bioniche Pharma USA, LLC) and Mylan Institutional Inc. (formerly UDL Laboratories, Inc.), Mylan's unit dose business[6]. This strategic move allowed Mylan to consolidate its institutional offerings and strengthen its position in the market.

Market Presence

Mylan Institutional has established a strong presence in the North American market, particularly in the United States. The company's focus on institutional customers, including hospitals and long-term care facilities, has allowed it to capture a significant market share in this segment[6].

Mylan Institutional's Market Position

Mylan Institutional holds a leading position in the U.S. pharmaceutical market, particularly in the generics sector. The company's market position is bolstered by its parent company's (Mylan N.V., now Viatris) global presence and extensive product portfolio.

Market Share and Ranking

While specific market share data for Mylan Institutional is not readily available, its parent company, Mylan, has consistently ranked among the top generic pharmaceutical companies globally. In the U.S., one in every 11 prescriptions dispensed is a Mylan product, highlighting the company's significant market penetration[6].

Product Portfolio

Mylan Institutional's product portfolio is diverse, focusing on injectable and unit dose products. This specialized offering sets it apart from competitors and allows it to cater to the specific needs of institutional customers[6].

Key Strengths of Mylan Institutional

Mylan Institutional's success can be attributed to several key strengths that give it a competitive edge in the pharmaceutical market.

Robust Research and Development

Mylan, the parent company of Mylan Institutional, has a strong focus on research and development. With over 3,000 R&D professionals and more than 4,000 patents filed globally, the company demonstrates a commitment to innovation and product development[3].

Vertically Integrated Operations

Mylan's vertically integrated platform, which includes Mylan Institutional, provides significant operational efficiencies and economies of scale. This integration allows for better control over the supply chain and quality of products[1].

Global Reach and Local Expertise

While Mylan Institutional primarily serves the North American market, it benefits from Mylan's global presence in over 165 countries. This global reach, combined with local market expertise, allows the company to adapt to diverse regulatory environments and market needs[1].

Quality and Compliance Focus

Mylan Institutional, like its parent company, places a strong emphasis on quality control and regulatory compliance. This focus is crucial in the pharmaceutical industry and helps build trust with institutional customers and regulatory bodies[1].

"Mylan's dedication to quality is evident in its adherence to rigorous regulatory standards and its commitment to continuously enhancing manufacturing processes. By maintaining a focus on quality, Mylan aims to instill confidence in patients and healthcare providers, ensuring that every product that bears its name is safe, effective, and reliable."[1]

Strategic Insights: Mylan Institutional's Approach to Market Dominance

Mylan Institutional's strategy for market dominance is multifaceted, leveraging its strengths and addressing market opportunities.

Focus on Institutional Customers

By specializing in products for institutional customers, Mylan Institutional has carved out a niche for itself in the pharmaceutical market. This focus allows the company to tailor its offerings to the specific needs of hospitals, long-term care facilities, and other healthcare institutions[6].

Expansion of Product Portfolio

Mylan Institutional continually works on expanding its product portfolio, particularly in high-value areas such as complex generics and biosimilars. This strategy allows the company to stay competitive and meet evolving market demands[3].

Leveraging Parent Company Resources

As part of the larger Mylan (now Viatris) organization, Mylan Institutional benefits from shared resources, including research and development capabilities, manufacturing facilities, and global distribution networks. This synergy allows for more efficient operations and faster time-to-market for new products[1].

Strategic Partnerships and Acquisitions

Mylan has a history of strategic partnerships and acquisitions to strengthen its market position. While specific to Mylan Institutional, this approach has likely contributed to its growth and expansion of capabilities[4].

Competitive Landscape: Mylan Institutional's Position Among Rivals

The pharmaceutical industry is highly competitive, with several major players vying for market share. Mylan Institutional faces competition from both generic and branded pharmaceutical companies.

Key Competitors

Some of Mylan Institutional's main competitors include:

  1. Teva Pharmaceutical Industries Ltd.
  2. Sandoz (a Novartis division)
  3. Pfizer Inc.
  4. Fresenius Kabi
  5. Hikma Pharmaceuticals[1]

Competitive Advantages

Mylan Institutional's competitive advantages include:

  1. Specialized focus on institutional customers
  2. Broad product portfolio in injectable and unit dose formats
  3. Access to Mylan's global resources and vertically integrated platform
  4. Strong quality control and regulatory compliance track record[1][6]

Market Trends and Future Outlook

The pharmaceutical industry is constantly evolving, influenced by various factors such as technological advancements, regulatory changes, and shifting healthcare needs.

Growing Demand for Generic Drugs

The demand for generic drugs continues to grow globally, driven by the need for cost-effective healthcare solutions. This trend presents significant opportunities for companies like Mylan Institutional[1].

Biosimilars Market Expansion

The biosimilars market is expected to grow substantially in the coming years. Mylan, including Mylan Institutional, has identified this as a key area for future growth[1].

Increasing Focus on Specialty Pharmaceuticals

There's a growing emphasis on specialty pharmaceuticals, particularly in areas like oncology and autoimmune diseases. Mylan Institutional's parent company has been expanding its presence in this high-value segment[1].

Challenges and Potential Threats

While Mylan Institutional has a strong market position, it faces several challenges and potential threats.

Pricing Pressures

The generic pharmaceutical industry faces ongoing pricing pressures, which can impact profitability. Mylan Institutional must continually find ways to optimize its operations to maintain competitiveness[1].

Regulatory Hurdles

The pharmaceutical industry is heavily regulated, and changes in regulations can significantly impact operations. Mylan Institutional must stay agile to adapt to evolving regulatory landscapes[1].

Patent Expirations

While patent expirations create opportunities for generic manufacturers, they also intensify competition. Mylan Institutional must continually innovate and expand its portfolio to maintain its market position[1].

Strategic Recommendations for Mylan Institutional

Based on the analysis of Mylan Institutional's market position, strengths, and challenges, several strategic recommendations can be made:

  1. Continue to focus on expanding the product portfolio, particularly in high-value areas like complex generics and biosimilars.
  2. Invest in research and development to stay ahead of market trends and maintain a competitive edge.
  3. Leverage the parent company's global presence to expand into new markets and diversify revenue streams.
  4. Strengthen partnerships with healthcare institutions to deepen market penetration and customer loyalty.
  5. Explore opportunities in emerging markets to drive growth and offset potential challenges in mature markets.

Key Takeaways

  • Mylan Institutional holds a strong position in the U.S. pharmaceutical market, particularly in the institutional segment.
  • The company's strengths include a robust R&D pipeline, vertically integrated operations, and a focus on quality and compliance.
  • Mylan Institutional faces competition from major pharmaceutical companies but maintains competitive advantages through its specialized focus and broad product portfolio.
  • Future growth opportunities lie in expanding into biosimilars and specialty pharmaceuticals, while challenges include pricing pressures and regulatory hurdles.
  • Continued innovation, strategic partnerships, and market expansion will be crucial for Mylan Institutional's future success.

FAQs

  1. What is Mylan Institutional's primary focus? Mylan Institutional primarily focuses on providing injectable and unit dose pharmaceutical products to institutional customers such as hospitals and long-term care facilities.

  2. How does Mylan Institutional differentiate itself from competitors? Mylan Institutional differentiates itself through its specialized focus on institutional customers, broad product portfolio, and access to Mylan's global resources and vertically integrated platform.

  3. What are the main challenges facing Mylan Institutional? The main challenges include pricing pressures in the generic drug market, regulatory hurdles, and intense competition from both generic and branded pharmaceutical companies.

  4. What growth opportunities exist for Mylan Institutional? Key growth opportunities include expanding into the biosimilars market, focusing on specialty pharmaceuticals, and leveraging Mylan's global presence to enter new markets.

  5. How does Mylan Institutional ensure product quality and compliance? Mylan Institutional, as part of Mylan, places a strong emphasis on quality control and regulatory compliance, adhering to rigorous standards and continuously enhancing manufacturing processes.

Sources cited: [1] https://pitchgrade.com/companies/mylan [3] https://investor.mylan.com/static-files/fb76cbc6-4ad0-4e72-b70f-5c2dfdd12969 [6] https://investor.mylan.com/static-files/290595fd-691c-4caa-b79e-aaabc8b7cd9c

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.