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Last Updated: April 21, 2025

Mylan Speciality Lp Company Profile


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Summary for Mylan Speciality Lp
International Patents:86
US Patents:7
Tradenames:14
Ingredients:9
NDAs:11

Drugs and US Patents for Mylan Speciality Lp

Showing 1 to 5 of 5 entries

Expired US Patents for Mylan Speciality Lp

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 8,163,723*PED ⤷  Try for Free
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 9,259,428*PED ⤷  Try for Free
Mylan Speciality Lp FELBATOL felbamate TABLET;ORAL 020189-001 Jul 29, 1993 5,082,861 ⤷  Try for Free
Mylan Speciality Lp FELBATOL felbamate SUSPENSION;ORAL 020189-003 Jul 29, 1993 5,082,861 ⤷  Try for Free
Mylan Speciality Lp ROWASA mesalamine ENEMA;RECTAL 019618-001 Dec 24, 1987 4,657,900 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 5 of 5 entries
Paragraph IV (Patent) Challenges for MYLAN SPECIALITY LP drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection (Auto-injector) 0.15 mg/0.3 mL and 0.3 mg/0.3 mL ➤ Subscribe 2008-11-21
➤ Subscribe Injection (Auto-injector) 0.15 mg/0.3 mL and 0.3 mg/0.3 mL ➤ Subscribe 2008-11-21
➤ Subscribe Nasal Spray 137 mcg/50 mcg per spray ➤ Subscribe 2014-06-13

Supplementary Protection Certificates for Mylan Speciality Lp Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1519731 132013902182575 Italy ⤷  Try for Free PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
1519731 13C0067 France ⤷  Try for Free PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
1519731 C01519731/01 Switzerland ⤷  Try for Free PRODUCT NAME: AZELASTIN + FLUTICASON; REGISTRATION NO/DATE: SWISSMEDIC 62675 06.05.2013
1519731 CA 2013 00023 Denmark ⤷  Try for Free PRODUCT NAME: AZELASTIN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG EN FARMACEUTISK ACCEPTABEL ESTER AF FLUTICASON, HERUNDER AZELASTIN HYDROCHLORID OG FLUTICASON PROPIONAT; NAT. REG. NO/DATE: MT49785 20130219; FIRST REG. NO/DATE: SK 24/0055/13-S 20130215
1519731 PA2013023 Lithuania ⤷  Try for Free PRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 5 of 5 entries
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: MYLAN SPECIALTY LP – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, understanding the competitive landscape is crucial for companies to maintain their edge and drive growth. Mylan Specialty LP, a key player in this sector, has established itself as a formidable force with a unique market position and strategic approach. Let's dive deep into Mylan Specialty's strengths, market position, and strategic insights to gain a comprehensive understanding of its role in the pharmaceutical competitive landscape.

Mylan Specialty LP: An Overview

Mylan Specialty LP, a subsidiary of Mylan Inc., focuses on developing and marketing specialty pharmaceutical products. The company's primary focus areas include respiratory, allergy, and psychiatric therapies[1]. As part of the larger Mylan organization, Mylan Specialty benefits from the parent company's global reach and extensive resources.

Core Business Areas

Mylan Specialty's operations primarily revolve around:

  1. Respiratory treatments
  2. Allergy medications
  3. Psychiatric therapies

These focus areas allow Mylan Specialty to carve out a niche within the broader pharmaceutical market, targeting specific patient needs and healthcare challenges.

Market Position and Global Presence

Mylan, as a whole, has established a strong global presence, operating in over 165 countries[2]. This extensive reach provides Mylan Specialty with a solid foundation to expand its specialty pharmaceutical offerings worldwide.

Mylan ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in approximately 140 countries and territories[1].

Key Markets

While Mylan Specialty's products are available globally, some of its key markets include:

  1. North America (United States and Canada)
  2. Europe
  3. Middle East and Africa
  4. India and Australia

This diverse geographical presence allows Mylan Specialty to tap into various market dynamics and healthcare systems, potentially offsetting risks associated with dependency on a single market.

Product Portfolio and Pipeline

Mylan Specialty's product portfolio is diverse, focusing on addressing unmet medical needs in its core therapeutic areas. The company's pipeline is robust, with a significant number of products in various stages of development.

Notable Products

Some of Mylan Specialty's notable products include:

  1. EpiPen® (epinephrine injection) for severe allergic reactions
  2. Perforomist® (formoterol fumarate) for chronic obstructive pulmonary disease (COPD)
  3. TOBI® Podhaler™ (tobramycin inhalation powder) for cystic fibrosis patients

Pipeline Strength

Mylan's overall pipeline is one of the industry's largest, with numerous products pending regulatory approval[1]. This robust pipeline positions Mylan Specialty for potential future growth and market expansion.

Competitive Advantages

Mylan Specialty's competitive advantages stem from its parent company's strengths and its own specialized focus. Let's explore some of these key advantages:

1. Vertical Integration

Mylan's vertically integrated structure, including one of the world's largest active pharmaceutical ingredient (API) operations, provides Mylan Specialty with significant cost advantages and supply chain control[1].

2. Research and Development Capabilities

With global R&D centers of excellence in locations such as Morgantown, West Virginia, and Hyderabad, India, Mylan Specialty benefits from robust research capabilities[6]. This allows for continuous innovation and product development.

3. Manufacturing Excellence

Mylan's state-of-the-art manufacturing facilities across different geographies ensure quality control, cost efficiency, and timely delivery of products[2].

4. Diverse Product Portfolio

Mylan Specialty's focus on complex, difficult-to-manufacture products in niche therapeutic areas helps differentiate it from competitors and potentially reduces pricing pressures[1].

Strategic Insights and Future Directions

To maintain and enhance its competitive position, Mylan Specialty is likely to focus on several strategic initiatives:

1. Expansion into Biosimilars

The growing biosimilars market presents a significant opportunity for Mylan Specialty. By leveraging its expertise in complex generics, the company can potentially gain a competitive advantage in this emerging market segment[2].

2. Focus on Respiratory Products

With the acquisition of Pfizer's respiratory delivery platform, Mylan Specialty is well-positioned to expand its respiratory franchise. This move aligns with the company's focus on difficult-to-produce, limited competition products[6].

3. Strategic Partnerships and Acquisitions

Mylan has a history of growth through strategic acquisitions and partnerships. Mylan Specialty is likely to continue this trend, seeking opportunities to enhance its product portfolio and expand its market reach[2].

4. Emphasis on Emerging Markets

Given Mylan's strong presence in emerging markets, Mylan Specialty has the potential to tap into these high-growth regions for its specialty products[1].

Challenges and Potential Threats

Despite its strong position, Mylan Specialty faces several challenges in the competitive pharmaceutical landscape:

1. Intense Competition

The pharmaceutical industry is highly competitive, with numerous players vying for market share. This competition can impact pricing power and profitability[2].

2. Regulatory Hurdles

As with all pharmaceutical companies, Mylan Specialty must navigate complex regulatory environments across different markets. Changes in regulations can impact product approvals and market access.

3. Pricing Pressures

Increasing focus on healthcare costs globally can lead to pricing pressures, potentially impacting Mylan Specialty's revenue and profitability.

4. Patent Expirations

As patents expire on key products, Mylan Specialty may face increased competition from generic alternatives, potentially impacting market share and revenues.

Competitive Landscape Analysis

To fully understand Mylan Specialty's position, it's crucial to analyze its performance relative to key competitors:

1. Teva Pharmaceutical Industries Ltd.

Teva, a global leader in generic medicines, competes with Mylan Specialty in several therapeutic areas, including respiratory and central nervous system treatments.

2. Pfizer Inc.

While Pfizer is primarily known for its branded drugs, its Upjohn division competes with Mylan Specialty in the off-patent and generic medicine space.

3. Novartis AG

Novartis's Sandoz division is a major player in the generic and biosimilar markets, competing with Mylan Specialty across various therapeutic areas.

SWOT Analysis

Let's summarize Mylan Specialty's position using a SWOT analysis:

Strengths

  • Strong global presence
  • Diverse product portfolio
  • Robust manufacturing capabilities
  • Vertical integration

Weaknesses

  • Overreliance on certain key products
  • Potential vulnerability to patent expirations

Opportunities

  • Expansion into biosimilars
  • Growth in emerging markets
  • Strategic partnerships and acquisitions

Threats

  • Intense competition
  • Regulatory challenges
  • Pricing pressures

Key Takeaways

Mylan Specialty LP, leveraging the strengths of its parent company Mylan Inc., has established a strong position in the specialty pharmaceutical market. Its focus on complex, difficult-to-manufacture products in niche therapeutic areas provides a competitive advantage. The company's global presence, vertically integrated structure, and robust pipeline position it well for future growth.

However, Mylan Specialty faces challenges including intense competition, regulatory hurdles, and pricing pressures. To maintain and enhance its competitive position, the company will likely focus on expanding into biosimilars, strengthening its respiratory franchise, pursuing strategic partnerships and acquisitions, and tapping into emerging markets.

As the pharmaceutical landscape continues to evolve, Mylan Specialty's ability to innovate, adapt to market changes, and leverage its strengths will be crucial in determining its future success and market position.

FAQs

  1. Q: What are Mylan Specialty's main therapeutic focus areas? A: Mylan Specialty primarily focuses on respiratory, allergy, and psychiatric therapies.

  2. Q: How does Mylan Specialty benefit from Mylan Inc.'s global presence? A: Mylan's global presence in over 165 countries provides Mylan Specialty with a solid foundation to expand its specialty pharmaceutical offerings worldwide.

  3. Q: What is one of Mylan Specialty's key competitive advantages? A: One key advantage is Mylan's vertically integrated structure, including one of the world's largest active pharmaceutical ingredient (API) operations, which provides significant cost advantages and supply chain control.

  4. Q: What potential growth area is Mylan Specialty likely to explore? A: Mylan Specialty is likely to focus on expanding into the biosimilars market, leveraging its expertise in complex generics.

  5. Q: What are some of the main challenges facing Mylan Specialty? A: Key challenges include intense competition in the pharmaceutical industry, regulatory hurdles, pricing pressures, and potential impacts from patent expirations.

Sources cited: [1] https://investor.mylan.com/static-files/958618e3-6c6d-4478-92af-6c6ac0030d98 [2] https://pitchgrade.com/companies/mylan [6] https://investor.mylan.com/static-files/290595fd-691c-4caa-b79e-aaabc8b7cd9c

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