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Last Updated: April 18, 2025

Shire Company Profile


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What is the competitive landscape for SHIRE

SHIRE has twenty-four approved drugs.



Drugs and US Patents for Shire

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Shire DOPAR levodopa CAPSULE;ORAL 016913-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-002 Dec 24, 1991 DISCN No No ⤷  Try for Free ⤷  Try for Free
Shire Richwood X-TROZINE phendimetrazine tartrate CAPSULE;ORAL 087394-001 Sep 22, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free
Shire Richwood X-TROZINE L.A. phendimetrazine tartrate CAPSULE, EXTENDED RELEASE;ORAL 087371-001 Aug 24, 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
Showing 1 to 4 of 4 entries

Expired US Patents for Shire

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-001 Jun 19, 1990 3,740,395 ⤷  Try for Free
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-001 Jun 19, 1990 3,864,487 ⤷  Try for Free
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-003 Dec 24, 1991 4,244,946 ⤷  Try for Free
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-001 Dec 24, 1991 4,244,946 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Shire – Market Position, Strengths & Strategic Insights

Shire plc, a leading global biotechnology company, has established itself as a formidable player in the pharmaceutical industry. With a focus on rare diseases and specialty therapies, Shire has carved out a unique position in the market. This analysis delves into Shire's market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

Shire's Market Position

Shire has consistently demonstrated strong growth and market presence, particularly in its core therapeutic areas. The company's strategic focus on rare diseases and specialty pharmaceuticals has allowed it to build a robust portfolio and establish leadership positions in key markets.

Revenue Growth and Market Share

Shire has experienced impressive revenue growth over the years. In 2007, the company reported total revenue of $2.4 billion, which grew to $3.5 billion by 2010[5]. This growth trajectory continued, with Shire aiming to reach $10 billion in product sales by 2020[1]. The company's ability to consistently increase revenue demonstrates its strong market position and effective growth strategies.

Geographic Expansion

While Shire initially had a strong focus on the US market, the company has made significant strides in expanding its global presence. By 2010, sales outside North America and the UK had more than tripled to $900 million[5]. This geographic diversification has not only reduced Shire's dependence on a single market but also opened up new growth opportunities.

Therapeutic Area Leadership

Shire has established leadership positions in several key therapeutic areas:

  1. Rare Diseases: By 2013, Shire's rare disease portfolio generated $2.0 billion in product sales, with expectations to exceed $3 billion by 2020[1].

  2. Neuroscience: The company's neuroscience products, including treatments for ADHD, brought in $1.6 billion in 2013, with projections to surpass $3 billion by 2020[1].

  3. Gastrointestinal (GI): Shire's GI franchise generated $0.8 billion in 2013, with expectations to reach over $1.3 billion by 2020[1].

"We have created leading franchises in Rare Diseases, Neuroscience and Gastrointestinal (GI) and are moving into promising new therapeutic areas such as ophthalmology, as well as boosting our innovative pipeline." - Flemming Ornskov, Chief Executive Officer of Shire[1]

Shire's Key Strengths

Shire's success in the pharmaceutical industry can be attributed to several key strengths that set it apart from competitors.

Focused Strategy

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of specialist physicians[3]. This focused approach allows the company to concentrate its resources on specific therapeutic areas, leading to deeper expertise and stronger market positions.

Innovative Pipeline

Shire has consistently invested in research and development to maintain a robust and innovative pipeline. The company's pipeline includes promising candidates in rare diseases, neuroscience, and gastrointestinal disorders. For example, Shire has made progress with SHP465 for ADHD in adults and LDX for Binge Eating Disorder[1].

Strategic Acquisitions

Shire has effectively used acquisitions to strengthen its portfolio and enter new therapeutic areas. Notable acquisitions include:

  • ViroPharma, which bolstered Shire's rare disease business[1]
  • Lumena, expanding Shire's presence in rare GI disorders[1]
  • Premacure, entering the ophthalmology space[1]
  • Fibrotech, adding assets in diabetic nephropathy[1]

Efficient Operating Model

Under new management, Shire has significantly improved its operational efficiency. The company increased its Non GAAP EBITDA margins from 37% in Q1 2013 to 45% in Q1 2014[1]. This improvement was achieved through:

  • Transitioning to a 'One Shire' organization structure
  • Integrating R&D under a single leadership team
  • Creating a consolidated international structure
  • Streamlining corporate functions

Strong Intellectual Property Protection

Shire focuses on products with strong intellectual property protection, particularly in the US and Europe[3]. This strategy helps protect the company's market position and ensures sustained revenue streams from key products.

Strategic Insights

Shire's strategic decisions and market approach offer valuable insights for pharmaceutical industry professionals and investors.

Focus on Niche Markets

Shire's success demonstrates the value of focusing on niche markets with high unmet needs. By concentrating on rare diseases and specialty pharmaceuticals, Shire has been able to build strong market positions with less competition from larger pharmaceutical companies.

Balancing Portfolio Diversification

Shire has effectively balanced its portfolio to reduce dependence on any single product. In 2006, one product (Adderall) accounted for about 45% of sales. By 2010, no single product provided more than 20% of revenue[5]. This diversification strategy helps mitigate risks associated with patent expirations or market changes.

Leveraging Acquisitions for Growth

Shire's strategic use of acquisitions has been crucial to its growth strategy. The company has successfully integrated acquired assets to strengthen its existing franchises and enter new therapeutic areas. This approach allows Shire to quickly expand its portfolio and pipeline while leveraging its existing infrastructure.

Emphasis on Global Expansion

Recognizing the limitations of relying heavily on the US market, Shire has actively pursued international opportunities. This global expansion strategy has not only driven growth but also reduced the company's exposure to market-specific risks.

Investment in Innovation

Shire's continued investment in R&D and focus on innovative therapies have been key to its success. By maintaining a strong pipeline and entering new therapeutic areas like ophthalmology, Shire positions itself for future growth and maintains its competitive edge.

Competitive Landscape

To fully understand Shire's position, it's essential to consider the broader competitive landscape in the pharmaceutical industry.

Key Competitors

Shire faces competition from both large pharmaceutical companies and smaller biotechnology firms specializing in rare diseases and specialty pharmaceuticals. Some notable competitors include:

  1. Biogen
  2. Vertex Pharmaceuticals
  3. BioMarin Pharmaceutical
  4. Alexion Pharmaceuticals

Competitive Advantages

Shire's competitive advantages in the market include:

  1. Strong position in rare diseases
  2. Diversified portfolio across multiple therapeutic areas
  3. Global presence with a strong foothold in the US market
  4. Efficient operating model with high EBITDA margins
  5. Robust pipeline of innovative therapies

Market Trends

Several trends in the pharmaceutical industry impact Shire's competitive position:

  1. Increasing focus on rare diseases and orphan drugs
  2. Growing demand for specialty pharmaceuticals
  3. Emphasis on value-based healthcare
  4. Increasing importance of global markets
  5. Rising competition in key therapeutic areas

Future Outlook

Based on Shire's current position and strategic initiatives, the company's future outlook appears promising.

Growth Projections

Shire has set ambitious growth targets, aiming to reach $10 billion in product sales by 2020[1]. This goal is supported by expected growth across its key franchises:

  • Rare Diseases: Projected to exceed $3 billion by 2020
  • Neuroscience: Expected to surpass $3 billion by 2020
  • GI: Anticipated to reach over $1.3 billion by 2020

Pipeline Potential

Shire's pipeline includes several promising candidates that could drive future growth:

  1. Lifitegrast for dry eye disease (expected NDA filing in Q1 2015)[1]
  2. SHP465 for adult ADHD (expected launch in H1 2015)[1]
  3. LDX for Binge Eating Disorder (expected launch in Q1 2015)[1]

Emerging Therapeutic Areas

Shire is actively expanding into new therapeutic areas, which could provide additional growth opportunities:

  1. Ophthalmology
  2. Hematology/Oncology
  3. Fibrosis
  4. Intrathecal therapies

Key Takeaways

  1. Shire has established strong market positions in rare diseases, neuroscience, and gastrointestinal disorders.
  2. The company's focused strategy and efficient operating model have driven significant revenue growth and margin improvement.
  3. Strategic acquisitions and a robust pipeline have positioned Shire for continued growth and expansion into new therapeutic areas.
  4. Shire's global expansion efforts have reduced its dependence on the US market and opened up new growth opportunities.
  5. The company's emphasis on niche markets and innovative therapies provides a competitive advantage in the pharmaceutical industry.

FAQs

  1. Q: What are Shire's main therapeutic areas of focus? A: Shire focuses primarily on rare diseases, neuroscience, and gastrointestinal disorders.

  2. Q: How has Shire's revenue growth trajectory been in recent years? A: Shire has shown strong revenue growth, increasing from $2.4 billion in 2007 to $3.5 billion in 2010, with aims to reach $10 billion in product sales by 2020.

  3. Q: What strategies has Shire employed to expand globally? A: Shire has focused on international opportunities, tripling its sales outside North America and the UK to $900 million by 2010.

  4. Q: How has Shire improved its operational efficiency? A: Shire increased its Non GAAP EBITDA margins from 37% to 45% by transitioning to a 'One Shire' structure, integrating R&D, and streamlining corporate functions.

  5. Q: What are some of Shire's key pipeline candidates? A: Key pipeline candidates include Lifitegrast for dry eye disease, SHP465 for adult ADHD, and LDX for Binge Eating Disorder.

Sources cited: [1] https://www.biospace.com/b-shire-plc-b-release-the-path-to-us-10-billion-in-product-sales-by-2020 [3] https://www.biospace.com/shire-pharmaceuticals-excellent-performance-across-all-areas-of-the-business-and-accelerating-new-product-sales-drive-revenue-growth-of-36-percent [5] https://impact.econ-asia.com/perspectives/health/case-study/search-value-shire-pharmaceuticals-changes-its-business-model

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