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Last Updated: March 21, 2025

Exelixis Company Profile


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Summary for Exelixis
International Patents:210
US Patents:11
Tradenames:2
Ingredients:1
NDAs:2
Patent Litigation for Exelixis: See patent lawsuits for Exelixis

Drugs and US Patents for Exelixis

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-001 Apr 25, 2016 RX Yes No 11,098,015 ⤷  Try for Free ⤷  Try for Free
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-001 Apr 25, 2016 RX Yes No 8,877,776 ⤷  Try for Free Y Y ⤷  Try for Free
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-001 Nov 29, 2012 RX Yes No 11,298,349 ⤷  Try for Free Y ⤷  Try for Free
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-002 Apr 25, 2016 RX Yes No 9,724,342 ⤷  Try for Free Y ⤷  Try for Free
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-001 Apr 25, 2016 RX Yes No 10,034,873 ⤷  Try for Free ⤷  Try for Free
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-001 Nov 29, 2012 RX Yes No 7,579,473 ⤷  Try for Free Y Y ⤷  Try for Free
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-001 Apr 25, 2016 RX Yes No 7,579,473 ⤷  Try for Free Y 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

Expired US Patents for Exelixis

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-001 Apr 25, 2016 8,497,284 ⤷  Try for Free
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-002 Apr 25, 2016 8,497,284 ⤷  Try for Free
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 8,497,284 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for Exelixis Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2213661 1490053-4 Sweden ⤷  Try for Free PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/13/890 20140326
2213661 92508 Luxembourg ⤷  Try for Free PRODUCT NAME: CABOZANTINIB ET TOUTES LES FORMES THERAPEUTIQUEMENT EQUIVALENTES QUI EN DERIVENT TELLES QUE PROTEGEES PAR LE BREVET DE BASE, Y COMPRIS LES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140326
2213661 C02213661/01 Switzerland ⤷  Try for Free PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66471 15.12.2017
2213661 300678 Netherlands ⤷  Try for Free PRODUCT NAME: CABOZANTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326
2213661 14C0067 France ⤷  Try for Free PRODUCT NAME: CABOZANTINIB ET TOUTE FORME THERAPEUTIQUEMENT EQUIVALENTE COUVERTE PAR LE BREVET DE BASE,INCLUANT SES SELS PHARMACEUTIQUEMENT EQUIVALENTS.; REGISTRATION NO/DATE: EU/1/13/890 20140326
2213661 132014902289810 Italy ⤷  Try for Free PRODUCT NAME: CABOZANTINIB(COMETRIQ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/890/001,002,003, 20140326
2213661 CR 2014 00039 Denmark ⤷  Try for Free PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140326
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

In the dynamic and fiercely competitive pharmaceutical industry, Exelixis has emerged as a formidable player, carving out a significant niche in the oncology market. This comprehensive analysis delves into Exelixis's market position, strengths, and strategic insights, offering a detailed look at how the company is navigating the complex landscape of cancer therapeutics.

Exelixis: A Brief Overview

Founded in 1994, Exelixis has evolved from a functional genomics startup to a fully integrated biopharmaceutical company focused on developing and commercializing novel therapies for cancer treatment[5]. The company's name, derived from the Greek word for evolution, aptly reflects its journey and adaptability in the ever-changing pharmaceutical landscape.

Core Focus and Product Portfolio

Exelixis has established itself as a leader in the development of kinase inhibitors for cancer treatment, with a particular emphasis on renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC)[2]. The company's flagship product, Cabometyx (cabozantinib), has been the cornerstone of its success, generating significant revenue and positioning Exelixis as a key player in the oncology market.

In fiscal year 2024, the Cabozantinib franchise achieved approximately $1.805 billion in preliminary U.S. net product revenues[6], underscoring its importance to Exelixis's financial performance and market position.

Market Position and Competitive Landscape

Exelixis has carved out a strong position in the oncology market, particularly in genitourinary (GU), gastrointestinal (GI), and thoracic oncology[2]. This focus aligns with areas of high unmet medical need and significant market potential, allowing the company to compete effectively against both established pharmaceutical giants and emerging biotech firms.

Market Share and Financial Performance

As of Q3 2024, Exelixis held a 0.40% market share relative to its competitors in its segment[10]. While this may seem modest, it's important to consider the company's focused approach and the highly fragmented nature of the oncology market. Exelixis's financial performance has been robust, with the company reporting:

  • Total revenue of $2.08 billion over the last twelve months
  • 17.3% revenue growth year-over-year
  • Strong liquidity with a current ratio of 3.93[2]

These figures demonstrate Exelixis's solid financial footing and its ability to compete effectively in the market.

Strengths and Competitive Advantages

Exelixis's success in the pharmaceutical industry can be attributed to several key strengths and competitive advantages:

1. Strong Oncology Focus

Exelixis's unwavering focus on oncology has positioned the company as a leader in cancer therapies. This specialization has allowed the company to develop deep expertise and build strong relationships within the oncology community.

2. Established Product Portfolio

The company's approved products, particularly Cabometyx, provide a stable revenue base and demonstrate Exelixis's ability to bring successful therapies to market. In 2022, Exelixis reported the following sales figures for its key products:

  • Cabometyx: $1,095 million
  • Cotellic (cobimetinib): $150 million
  • Zykadia (ceritinib): $70 million[3]

3. Robust R&D Capabilities

Exelixis invested approximately $317 million in R&D in 2022, highlighting its commitment to innovation[3]. The company's research capabilities are further evidenced by its pipeline of over 20 clinical programs, focusing on novel therapeutic targets in oncology.

4. Strategic Partnerships

Exelixis has established valuable partnerships with leading pharmaceutical companies for the commercialization of its products outside the U.S. and Japan. These collaborations extend the company's global reach and provide additional revenue streams[2].

Strategic Insights and Future Growth Drivers

Exelixis is pursuing several strategies to drive future growth and maintain its competitive edge in the oncology market:

1. Label Expansions

The company is actively seeking to expand the indications for Cabometyx, with a particular focus on neuroendocrine tumors (NET). A supplemental New Drug Application (sNDA) for Cabometyx in advanced NET has been accepted by the FDA, with a target action date set for April 3, 2025[2].

2. Pipeline Advancement

Zanzalintinib, Exelixis's next-generation tyrosine kinase inhibitor, is viewed as a significant growth driver. Analysts project potential U.S. sales of $5 billion by 2033 for this promising drug candidate[2].

3. Business Development

Exelixis is actively pursuing business development opportunities, focusing on late-stage assets in GI, GU, and thoracic oncology. This strategy aims to diversify the company's portfolio and reduce reliance on Cabometyx[2].

4. International Expansion

Through partnerships with companies like IPSEN, Exelixis is expanding its global footprint, providing additional revenue streams and access to new markets[2].

Challenges and Risks

Despite its strong position, Exelixis faces several challenges that could impact its future performance:

1. Patent Litigation

While Exelixis recently secured a favorable ruling extending Cabometyx's patent protection until 2030, the risk of future patent challenges remains a concern for investors[2].

2. Clinical Trial Outcomes

The success of Exelixis's pipeline, particularly zanzalintinib, is crucial for long-term growth. Negative trial results could significantly impact the company's prospects[2].

3. Competitive Pressures

The oncology market is rapidly evolving, with new therapies and treatment modalities emerging. Exelixis must continue to innovate to maintain its competitive edge[2].

4. Regulatory Hurdles

Exelixis's growth strategy relies heavily on label expansions and new drug approvals, which are subject to regulatory scrutiny and potential delays[2].

Exelixis's Corporate Values and Sustainability

Exelixis's commitment to innovation and patient care is reflected in its corporate values and sustainability efforts. The company's 2024 Corporate Values & Sustainability Report highlights its dedication to:

  • Driving results for patients
  • Resilience in the face of adversity
  • Celebrating a history of prolific drug discovery
  • Uniting to launch innovative medicines
  • Giving people hope through drug development[7]

These values underscore Exelixis's patient-centric approach and its commitment to sustainable growth in the pharmaceutical industry.

Competitive Analysis: Exelixis vs. Key Rivals

To better understand Exelixis's position in the market, it's important to compare the company to some of its key competitors:

1. Bristol-Myers Squibb

  • Larger market cap and broader portfolio
  • Strong presence in immuno-oncology with Opdivo
  • Greater resources for R&D and acquisitions

2. Merck

  • Industry leader with blockbuster drug Keytruda
  • Extensive global reach and diverse pipeline
  • Significant financial resources for expansion and innovation

3. Pfizer

  • Diversified portfolio across multiple therapeutic areas
  • Strong oncology presence with drugs like Ibrance
  • Substantial resources for M&A and pipeline development

While these larger pharmaceutical companies have certain advantages in terms of scale and resources, Exelixis's focused approach and expertise in kinase inhibitors allow it to compete effectively in its chosen market segments.

Future Outlook and Market Trends

The future of cancer care is likely to be shaped by new chemical entities and combination regimens. Exelixis is well-positioned to capitalize on these trends with its:

  • Expanding pipeline of small molecules and biotherapeutics
  • Focus on antibody-drug conjugates
  • Ongoing clinical trials exploring combination therapies

As the company continues to invest in R&D and expand its product portfolio, it has the potential to strengthen its market position and drive long-term growth in the oncology space.

Key Takeaways

  • Exelixis has established a strong position in the oncology market, particularly in renal cell carcinoma and hepatocellular carcinoma.
  • The company's flagship product, Cabometyx, continues to drive revenue growth and market expansion.
  • Exelixis's focused R&D efforts and robust pipeline, including promising candidates like zanzalintinib, position it for future growth.
  • Strategic partnerships and international expansion efforts are extending Exelixis's global reach.
  • While facing challenges such as patent litigation and intense competition, Exelixis's specialized expertise and innovative approach provide a solid foundation for continued success in the oncology market.

FAQs

  1. Q: What is Exelixis's primary focus in the pharmaceutical industry? A: Exelixis primarily focuses on developing and commercializing novel therapies for cancer treatment, with a particular emphasis on kinase inhibitors for renal cell carcinoma and hepatocellular carcinoma.

  2. Q: How does Exelixis's market share compare to its competitors? A: As of Q3 2024, Exelixis held a 0.40% market share relative to its competitors in its segment, reflecting its focused approach in the highly fragmented oncology market.

  3. Q: What are the key growth drivers for Exelixis in the coming years? A: Key growth drivers include label expansions for Cabometyx, advancement of pipeline candidates like zanzalintinib, strategic business development, and international expansion through partnerships.

  4. Q: How is Exelixis addressing the challenge of patent protection for its products? A: Exelixis has recently secured a favorable ruling extending Cabometyx's patent protection until 2030, but continues to actively manage its intellectual property portfolio and explore new innovations to maintain its competitive edge.

  5. Q: What sets Exelixis apart from larger pharmaceutical competitors in the oncology space? A: Exelixis's focused approach, deep expertise in kinase inhibitors, and agile R&D capabilities allow it to compete effectively against larger rivals, particularly in its chosen market segments within oncology.

Sources cited: [1] https://ipira.berkeley.edu/exelixis-inc [2] https://www.investing.com/news/swot-analysis/exelixiss-swot-analysis-cancer-drug-makers-stock-faces-patent-cliff-pipeline-promise-93CH-3838641 [3] https://canvasbusinessmodel.com/products/exelixis-swot-analysis [5] https://www.exelixis.com/our-story/ [6] https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-preliminary-fiscal-year-2024-financial [7] https://www.exelixis.com/wp-content/uploads/2024/10/FINAL-EXEL-2024-CVS-Report.pdf [10] https://csimarket.com/stocks/competitionSEG2.php?code=EXEL

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