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Last Updated: June 14, 2025

Keryx Biopharms Company Profile


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What is the competitive landscape for KERYX BIOPHARMS

KERYX BIOPHARMS has one approved drug.

There are three US patents protecting KERYX BIOPHARMS drugs.

There are one hundred and seventeen patent family members on KERYX BIOPHARMS drugs in twenty-three countries.

Summary for Keryx Biopharms
International Patents:117
US Patents:3
Tradenames:1
Ingredients:1
NDAs:1

Drugs and US Patents for Keryx Biopharms

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes 9,387,191 ⤷  Try for Free Y ⤷  Try for Free
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes 8,093,423 ⤷  Try for Free ⤷  Try for Free
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes 10,300,039 ⤷  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

Expired US Patents for Keryx Biopharms

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 5,753,706 ⤷  Try for Free
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 8,754,257 ⤷  Try for Free
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 8,299,298 ⤷  Try for Free
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 9,757,416 ⤷  Try for Free
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 8,901,349 ⤷  Try for Free
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 9,328,133 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

In the dynamic world of pharmaceutical companies, understanding the competitive landscape is crucial for success. Keryx Biopharmaceuticals, a company focused on developing and commercializing innovative therapies for patients with renal disease, has carved out a unique position in this challenging market. This comprehensive analysis will delve into Keryx's market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

The Renal Disease Market: A Growing Opportunity

The global renal disease market is expanding rapidly, driven by an aging population and increasing prevalence of chronic kidney disease (CKD). Keryx Biopharmaceuticals has strategically positioned itself to capitalize on this growth.

Market Size and Projections

The renal disease market is expected to reach $133.4 billion by 2026, growing at a CAGR of 7.3% from 2021 to 2026[1]. This substantial market size presents significant opportunities for companies like Keryx that specialize in renal therapies.

Keryx's Focus on Unmet Needs

Keryx has wisely chosen to focus on addressing unmet needs in the renal disease market, particularly in the areas of iron deficiency anemia and hyperphosphatemia in CKD patients. This targeted approach allows the company to differentiate itself from broader pharmaceutical players.

Keryx's Flagship Product: Auryxia

At the heart of Keryx's market position is its FDA-approved product, Auryxia (ferric citrate).

Dual Indications

Auryxia has been approved for two indications related to chronic kidney disease:

  1. Treatment of iron deficiency anemia in adult patients with CKD not on dialysis
  2. Control of serum phosphorus levels in adult patients with CKD on dialysis

This dual indication provides Keryx with a unique advantage in the market, allowing it to address multiple aspects of renal disease management with a single product[3].

Commercial Performance

Auryxia showed strong commercial momentum in 2018, with approximately 42,500 prescriptions in Q2, representing 101% growth over Q2 2017[3].

This impressive growth demonstrates the market's acceptance of Auryxia and Keryx's ability to effectively commercialize its product.

Keryx's Market Position

Keryx has established itself as a specialized player in the renal disease market, focusing on developing and commercializing innovative therapies for patients with kidney disease.

Niche Focus

By concentrating on renal disease, Keryx has developed deep expertise in this area, allowing it to compete effectively against larger pharmaceutical companies with more diverse portfolios.

Commercial Infrastructure

Keryx has built a commercial infrastructure focused on nephrology, with strong leaders who have long-standing relationships within the nephrology community[3]. This specialized sales force gives Keryx an advantage in reaching and educating healthcare providers about its products.

Strengths of Keryx Biopharmaceuticals

Innovative Product Portfolio

Keryx's primary strength lies in its innovative product, Auryxia, which addresses multiple aspects of CKD management. This unique positioning allows Keryx to offer a comprehensive solution to healthcare providers and patients.

Strong Patent Protection

Auryxia is protected by a robust patent portfolio, with patents extending until 2024 and beyond[6]. This intellectual property protection provides Keryx with a significant competitive advantage and the opportunity to maximize the commercial potential of Auryxia.

Experienced Management Team

Keryx boasts a management team with extensive experience in the renal disease space. This expertise is crucial in navigating the complex regulatory environment and effectively commercializing products in this specialized market.

Strategic Partnerships

Keryx has established strategic partnerships to enhance its market position. For example, its merger with Akebia Therapeutics in 2018 created a fully integrated renal company with enhanced capabilities[5].

Strategic Insights

Focus on Market Expansion

Keryx's strategy involves expanding the market for Auryxia by increasing awareness among healthcare providers and patients. The company has been investing in educational initiatives and marketing efforts to drive adoption of Auryxia.

Pipeline Development

While Auryxia is currently Keryx's primary focus, the company is also investing in pipeline development to ensure long-term growth. This includes exploring new indications for Auryxia and potentially in-licensing or acquiring complementary products.

Leveraging Merger Synergies

The merger with Akebia Therapeutics provides Keryx with significant opportunities for synergies. The combined company can leverage its expanded resources and expertise to accelerate growth and improve operational efficiency.

Competitive Landscape

Key Competitors

Keryx faces competition from both large pharmaceutical companies and smaller, specialized players in the renal disease market. Some key competitors include:

  1. Amgen (Sensipar, Parsabiv)
  2. Vifor Pharma (Velphoro)
  3. Akebia Therapeutics (now merged with Keryx)
  4. FibroGen (roxadustat)

Competitive Advantages

Keryx's competitive advantages include:

  1. Specialized focus on renal disease
  2. Dual indication for Auryxia
  3. Strong patent protection
  4. Established commercial infrastructure in nephrology

Market Challenges and Opportunities

Challenges

  1. Intense competition in the renal disease market
  2. Potential for generic competition after patent expiration
  3. Regulatory hurdles in expanding indications or gaining approval for new products

Opportunities

  1. Growing prevalence of chronic kidney disease
  2. Potential for expanding Auryxia's indications
  3. Increasing focus on value-based care in nephrology

Future Outlook

Keryx's future outlook appears promising, driven by the continued growth of Auryxia and potential synergies from its merger with Akebia Therapeutics. The company's specialized focus on renal disease positions it well to capitalize on the growing market opportunity.

Key Takeaways

  1. Keryx Biopharmaceuticals has established a strong position in the renal disease market with its flagship product, Auryxia.
  2. The company's specialized focus and experienced management team provide competitive advantages in a complex market.
  3. Keryx's merger with Akebia Therapeutics creates opportunities for synergies and accelerated growth.
  4. The growing renal disease market presents significant opportunities for Keryx to expand its market share.
  5. Continued investment in pipeline development and market expansion will be crucial for Keryx's long-term success.

FAQs

  1. What is Keryx Biopharmaceuticals' main product? Keryx's main product is Auryxia (ferric citrate), approved for treating iron deficiency anemia in CKD patients not on dialysis and controlling serum phosphorus levels in CKD patients on dialysis.

  2. How does Keryx differentiate itself from competitors? Keryx differentiates itself through its specialized focus on renal disease, dual indication for Auryxia, strong patent protection, and established commercial infrastructure in nephrology.

  3. What was the significance of Keryx's merger with Akebia Therapeutics? The merger created a fully integrated renal company with enhanced capabilities, providing opportunities for synergies and accelerated growth.

  4. What are the main challenges facing Keryx in the renal disease market? Key challenges include intense competition, potential for generic competition after patent expiration, and regulatory hurdles in expanding indications or gaining approval for new products.

  5. What is the market size for renal disease treatments? The global renal disease market is expected to reach $133.4 billion by 2026, growing at a CAGR of 7.3% from 2021 to 2026.

Sources cited: [1] https://www.biopharmadive.com/news/akebia-keryx-to-merge-creating-1b-kidney-disease-company/526761/ [3] https://ir.akebia.com/static-files/820ef52b-215b-4902-824f-92e259bde6b7 [5] https://ir.akebia.com/news-releases/news-release-details/akebia-therapeutics-and-keryx-biopharmaceuticals-complete-merger [6] https://www.annualreports.com/HostedData/AnnualReportArchive/k/NASDAQ_KERX_2014.pdf

Last updated: 2025-02-12

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