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Last Updated: April 21, 2025

Amgen Inc Company Profile


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Drugs and US Patents for Amgen Inc

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Amgen Inc LUMAKRAS sotorasib TABLET;ORAL 214665-003 Jun 26, 2024 RX Yes No ⤷  Try for Free ⤷  Try for Free
Amgen Inc LUMAKRAS sotorasib TABLET;ORAL 214665-003 Jun 26, 2024 RX Yes No 11,426,404 ⤷  Try for Free ⤷  Try for Free
Amgen Inc LUMAKRAS sotorasib TABLET;ORAL 214665-002 Jan 20, 2023 RX Yes Yes 11,827,635 ⤷  Try for Free Y Y ⤷  Try for Free
Amgen Inc LUMAKRAS sotorasib TABLET;ORAL 214665-001 May 28, 2021 RX Yes No 11,426,404 ⤷  Try for Free ⤷  Try for Free
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 AB RX Yes Yes 10,092,541*PED ⤷  Try for Free Y ⤷  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 5 of 5 entries

Expired US Patents for Amgen Inc

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 9,724,330 ⤷  Try for Free
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 9,724,330 ⤷  Try for Free
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 8,802,717 ⤷  Try for Free
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 7,208,516 ⤷  Try for Free
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 7,659,302 ⤷  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 AMGEN INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 10 mg, 20 mg and30 mg ➤ Subscribe 2018-03-22

Supplementary Protection Certificates for Amgen Inc Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
2962690 C 2019 032 Romania ⤷  Try for Free PRODUCT NAME: APREMILAST SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115
2962690 C20190029 00295 Estonia ⤷  Try for Free PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015
2962690 CA 2019 00033 Denmark ⤷  Try for Free PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116
2962690 CR 2019 00033 Denmark ⤷  Try for Free PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116
2962690 LUC00125 Luxembourg ⤷  Try for Free PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/14/981 20150116
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 5 of 5 entries
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Pharmaceutical Competitive Landscape Analysis: Amgen Inc – Market Position, Strengths & Strategic Insights

In the ever-evolving world of pharmaceuticals, Amgen Inc. stands as a titan, navigating the complex landscape with a mix of established products and promising pipeline candidates. As we delve into Amgen's market position, strengths, and strategic insights, we'll uncover the factors that have propelled this biotech giant to its current status and explore the challenges and opportunities that lie ahead.

Amgen's Market Position: A Global Biotech Leader

Amgen has firmly established itself as a leader in the biotechnology sector, with a significant global presence. As of 2024, the company generated an impressive $26.8 billion in revenue, solidifying its position as one of the world's largest pure-play biotechnology companies[1]. This financial prowess is a testament to Amgen's robust product portfolio and strategic market positioning.

Market Share and Competitive Standing

In the highly competitive pharmaceutical industry, Amgen has managed to carve out a substantial market share. According to recent data, Amgen holds approximately 4% of the market share in its sector as of Q3 2024[3]. While this may seem modest, it's important to note that the pharmaceutical market is highly fragmented, with numerous players vying for dominance.

"Today, Amgen is the world's largest pure play medical biotechnology company, generating 28.2 billion U.S. dollars of revenue and employing over 24,000 people worldwide."[1]

Global Footprint and Expansion

Amgen's global presence is a key factor in its market position. The company has strategically expanded its operations across various regions, allowing it to tap into diverse markets and mitigate risks associated with regional economic fluctuations. This global approach has been particularly beneficial in offsetting challenges in mature markets and capitalizing on growth opportunities in emerging economies.

Amgen's Core Strengths: Innovation and Financial Stability

Amgen's success is built on a foundation of several core strengths that have allowed it to maintain its competitive edge in the pharmaceutical industry.

Robust Product Portfolio

One of Amgen's primary strengths lies in its diverse and robust product portfolio. The company boasts several blockbuster drugs across multiple therapeutic areas, including:

  1. Enbrel (etanercept) for rheumatoid arthritis and other inflammatory conditions
  2. Prolia (denosumab) for osteoporosis
  3. Neulasta (pegfilgrastim) for reducing the risk of infection in cancer patients
  4. Repatha (evolocumab) for lowering cholesterol

These products, among others, contribute significantly to Amgen's revenue stream and market position. In 2023, Repatha alone saw a remarkable 36% increase in sales, reaching $2.22 billion[5].

Strong R&D Capabilities

Amgen's commitment to research and development is evident in its substantial R&D investment. In 2023, the company allocated 18% of its revenue to R&D activities[1]. This significant investment underscores Amgen's dedication to innovation and its strategy to maintain a competitive edge through the development of novel therapies.

Financial Stability

Amgen's financial stability is another key strength. The company's robust revenue growth and healthy financial ratios provide a solid foundation for future growth and investment. In 2024, Amgen reported:

  • Revenue growth of 21.2%
  • A healthy current ratio of 1.32[8]

These figures demonstrate Amgen's ability to generate consistent profits and maintain a strong balance sheet, crucial factors in the capital-intensive pharmaceutical industry.

Strategic Insights: Navigating Challenges and Opportunities

While Amgen's position in the market is strong, the company faces several challenges and opportunities that will shape its future trajectory.

Patent Expirations and Biosimilar Competition

One of the most significant challenges facing Amgen is the expiration of patents on key products. As patents expire, the company faces increased competition from biosimilars and generics. For instance, Enbrel, one of Amgen's top-selling drugs, has already faced biosimilar competition in Europe and may face similar challenges in the U.S. in the coming years.

To address this challenge, Amgen has adopted a multi-faceted strategy:

  1. Developing its own biosimilars to compete in this growing market segment
  2. Investing in new, innovative therapies to replenish its product pipeline
  3. Exploring life-cycle management strategies for existing products

Emerging Therapeutic Areas

Amgen is actively pursuing opportunities in emerging therapeutic areas, with a particular focus on obesity treatments. The company's development of MariTide (maridebart cafraglutide, AMG 133) represents a strategic move into the highly competitive obesity drug market[5]. This expansion into new therapeutic areas demonstrates Amgen's commitment to diversifying its portfolio and tapping into high-growth markets.

Strategic Acquisitions and Partnerships

Amgen has leveraged strategic acquisitions and partnerships to strengthen its market position and expand its capabilities. The acquisition of Horizon Therapeutics in 2023 for $27.8 billion exemplifies this strategy, bolstering Amgen's rare disease portfolio and expanding its presence in key therapeutic areas[5].

Competitive Landscape: Key Rivals and Market Dynamics

Amgen operates in a highly competitive industry, facing off against several major pharmaceutical and biotechnology companies. Understanding this competitive landscape is crucial for assessing Amgen's market position and future prospects.

Major Competitors

Amgen's primary competitors include:

  1. Roche
  2. Pfizer
  3. Johnson & Johnson
  4. Novartis
  5. Merck & Co.[2]

Each of these companies brings unique strengths and challenges to the market, creating a dynamic and competitive environment.

Comparative Analysis

When compared to its competitors, Amgen holds its own in several key areas:

  • Market Capitalization: As of October 2023, Amgen's market capitalization stood at $140 billion, placing it among the top global biotech companies[1].
  • R&D Investment: Amgen's 18% R&D spending as a share of revenue is competitive within the industry, demonstrating its commitment to innovation.
  • Product Portfolio: While some competitors may have larger overall portfolios, Amgen's focus on biotechnology gives it a unique position in the market.

Competitive Strategies

To maintain its competitive edge, Amgen employs several strategies:

  1. Focus on innovation through substantial R&D investment
  2. Strategic acquisitions to expand its product portfolio and market reach
  3. Expansion into emerging markets to drive growth
  4. Development of biosimilars to compete in this growing market segment

Pipeline Analysis: Future Growth Drivers

Amgen's pipeline is a critical component of its future growth prospects. The company has a diverse range of candidates in various stages of development across multiple therapeutic areas.

Key Pipeline Candidates

Some of the most promising candidates in Amgen's pipeline include:

  1. MariTide (AMG 133) for obesity
  2. AMG 513 for obesity and diabetes
  3. Olpasiran (AMG 890) for cardiovascular disease
  4. Rocatinlimab for atopic dermatitis
  5. Xaluritamig (AMG 509) for prostate cancer[5]

These candidates represent potential future growth drivers for Amgen, addressing significant unmet medical needs and tapping into large market opportunities.

Late-Stage Development

Amgen's late-stage pipeline is particularly robust, with several candidates in Phase 3 trials or nearing regulatory submission. This late-stage pipeline is crucial for maintaining Amgen's market position and offsetting potential revenue losses from patent expirations.

Market Trends and Future Outlook

As we look to the future, several market trends are likely to impact Amgen's strategic direction and market position.

Personalized Medicine

The trend towards personalized medicine, driven by advances in genomics and data analytics, presents both opportunities and challenges for Amgen. The company's strong R&D capabilities position it well to capitalize on this trend, but it will require continued investment and innovation.

Biosimilars Market Growth

The biosimilars market is expected to grow significantly in the coming years. Amgen's dual strategy of developing its own biosimilars while also defending its branded products against biosimilar competition will be crucial in navigating this evolving landscape.

Emerging Markets Expansion

Continued expansion into emerging markets represents a significant growth opportunity for Amgen. The company's global presence and diverse product portfolio position it well to capitalize on the growing healthcare needs in these markets.

SWOT Analysis: Amgen's Strategic Position

A SWOT analysis provides a comprehensive view of Amgen's strategic position in the market.

Strengths

  • Strong financial performance and stability
  • Robust product portfolio across multiple therapeutic areas
  • Significant investment in R&D (18% of revenue)
  • Global presence and market reach

Weaknesses

  • Dependence on a few key products for a significant portion of revenue
  • Exposure to patent expirations and biosimilar competition
  • Relatively smaller overall portfolio compared to some competitors

Opportunities

  • Expansion into emerging markets
  • Development of new therapies in high-growth areas (e.g., obesity, oncology)
  • Growth in the biosimilars market
  • Strategic acquisitions and partnerships

Threats

  • Intense competition in key therapeutic areas
  • Regulatory challenges and pricing pressures
  • Patent expirations on key products
  • Potential for disruptive technologies or therapies

Key Takeaways

  1. Amgen maintains a strong market position as a global biotech leader, with a 4% market share and $26.8 billion in revenue in 2024.
  2. The company's core strengths lie in its robust product portfolio, strong R&D capabilities, and financial stability.
  3. Amgen faces challenges from patent expirations and biosimilar competition but is actively pursuing strategies to mitigate these risks.
  4. The company's pipeline, particularly in areas like obesity and oncology, represents significant future growth potential.
  5. Amgen's competitive landscape is intense, with major rivals including Roche, Pfizer, and Johnson & Johnson.
  6. Future success will depend on Amgen's ability to navigate market trends, capitalize on emerging opportunities, and continue to innovate in key therapeutic areas.

FAQs

  1. Q: What is Amgen's current market share in the pharmaceutical industry? A: As of Q3 2024, Amgen holds approximately 4% market share in its sector.

  2. Q: How much does Amgen invest in research and development? A: Amgen allocated 18% of its revenue to R&D activities in 2023.

  3. Q: What are some of Amgen's key products? A: Some of Amgen's key products include Enbrel, Prolia, Neulasta, and Repatha.

  4. Q: How is Amgen addressing the challenge of patent expirations? A: Amgen is addressing patent expirations through strategies such as developing its own biosimilars, investing in new therapies, and exploring life-cycle management for existing products.

  5. Q: What are some promising candidates in Amgen's pipeline? A: Promising candidates in Amgen's pipeline include MariTide (AMG 133) for obesity, AMG 513 for obesity and diabetes, and Olpasiran (AMG 890) for cardiovascular disease.

Sources cited: [1] https://www.statista.com/topics/1910/amgen/ [2] https://pitchgrade.com/companies/amgen [3] https://csimarket.com/stocks/competitionSEG2.php?code=AMGN [5] https://www.amgen.com/newsroom/press-releases/2025/02/amgen-reports-fourth-quarter-and-full-year-2024-financial-results [8] https://www.investing.com/news/swot-analysis/amgens-swot-analysis-stock-outlook-amid-obesity-drug-race-93CH-3846730

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