You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 11, 2025

Fresenius Kabi Company Profile


✉ Email this page to a colleague

« Back to Dashboard


Drugs and US Patents for Fresenius Kabi

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa XYLOCAINE VISCOUS lidocaine hydrochloride SOLUTION;ORAL 009470-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa IOPAMIDOL-250 iopamidol INJECTABLE;INJECTION 074679-001 Apr 2, 1997 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 017584-001 Approved Prior to Jan 1, 1982 AP RX No No ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa XYLOCAINE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 016801-005 Jan 19, 1988 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4 magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate INJECTABLE;INJECTION 215371-001 Jun 8, 2022 AP RX No No ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa OMEGAVEN fish oil triglycerides EMULSION;INTRAVENOUS 210589-001 Jul 27, 2018 RX Yes Yes ⤷  Get Started Free ⤷  Get Started 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 Fresenius Kabi

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-001 Jan 11, 1984 6,589,960 ⤷  Get Started Free
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-005 Apr 30, 2009 6,589,960 ⤷  Get Started Free
Fresenius Kabi Usa OMEGAVEN fish oil triglycerides EMULSION;INTRAVENOUS 210589-002 Jul 27, 2018 10,350,186 ⤷  Get Started Free
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-002 Aug 4, 1994 6,589,960 ⤷  Get Started Free
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-006 Sep 24, 1996 7,828,787 ⤷  Get Started Free
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 4,695,576 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for FRESENIUS KABI drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 2 mg/mL, 100 mL ➤ Subscribe 2015-01-30
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe Oral Solution 5 mg/5mL ➤ Subscribe 2011-02-25
➤ Subscribe Tablets 2 mg, 4 mg, and 8 mg ➤ Subscribe 2013-08-05
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe Injection 2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials ➤ Subscribe 2006-11-13
➤ Subscribe Injection 2 mg/mL, 200 mL ➤ Subscribe 2015-09-03
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe Injection 2 mg/mL ➤ Subscribe 2011-06-22
➤ Subscribe Injection 10 mg/mL ➤ Subscribe 2011-11-04
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01

International Patents for Fresenius Kabi Drugs

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2012047845 ⤷  Get Started Free
Australia 2004289353 ⤷  Get Started Free
Japan 2016512455 ⤷  Get Started Free
European Patent Office 2968132 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2014081443 ⤷  Get Started Free
Australia 2014230834 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for Fresenius Kabi Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1718641 2012/008 Ireland ⤷  Get Started Free PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209
1635783 122014000024 Germany ⤷  Get Started Free PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
2768484 2019/054 Ireland ⤷  Get Started Free PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
1175904 2007C/048 Belgium ⤷  Get Started Free PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
0247633 62/1997 Austria ⤷  Get Started Free PRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
1874117 SPC/GB14/041 United Kingdom ⤷  Get Started Free PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
>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: Fresenius Kabi – Market Position, Strengths & Strategic Insights

Last updated: July 30, 2025

Introduction

Fresenius Kabi, a global healthcare company headquartered in Germany, specializing in lifesaving medicines and infusion therapies, has established a significant presence within the pharmaceutical and medical device sectors. As part of the Fresenius Group, the company leverages its extensive innovative R&D capabilities, robust manufacturing network, and strategic market positioning to compete effectively across multiple therapeutic areas. This analysis deconstructs Fresenius Kabi’s current market position, delineates its core strengths, and provides strategic insights to inform future positioning and competitive actions within the evolving pharmaceutical landscape.

Market Position Overview

Fresenius Kabi excels as a leader in intravenous (IV) drugs, infusion solutions, clinical nutrition, and generic pharmaceuticals. The company operates in over 100 countries, with substantial footprints in North America, Europe, and Asia. Its global revenue exceeds $7 billion (as of 2022), reflecting consistent growth driven by the demand for critical care and hospital-focused medicines.[1]

In the context of the broader pharmaceutical industry, Fresenius Kabi positions itself as a provider of essential medicines rather than a blockbuster-focused entity. Its emphasis on hospital-administered products, rather than consumer portfolios, differentiates its strategic approach—particularly in critical care, chemotherapy, and anesthesia markets. The company's revenues are primarily derived from sterile IV medicines, which account for approximately 60% of its sales, highlighting its specialization focus.[2]

While competing with pharmaceutical giants like Pfizer, Novartis, and local players such as Hikma Pharmaceuticals, Fresenius Kabi maintains distinct market niches through its specialization, quality standards, and global reach. Its presence in the growing biosimilar and generic segments further cements its strategic footprint.

Core Strengths

1. Robust Portfolio of Critical Care and Infusion Solutions

Fresenius Kabi’s core competency lies in its comprehensive portfolio of infusion therapies, including parenteral nutrition, electrolyte solutions, and cytotoxic drugs used in chemotherapy. The company's products are embedded within hospital protocols worldwide, ensuring consistent demand. Its portfolio’s breadth and depth allow for cross-selling opportunities, increasing customer loyalty and market share (notably in ICU and oncology segments).

2. Extensive Manufacturing and Supply Chain Infrastructure

The company operates over 30 manufacturing sites globally, with stringent compliance to international quality standards such as ISO and cGMP. This infrastructure ensures reliable product supply, even amid disruptions such as the COVID-19 pandemic. Its strategic regional manufacturing hubs, especially in Europe and Asia, reduce logistical costs and compliance risks.

3. Focus on Innovation and Biosimilars

Fresenius Kabi invests heavily in R&D, particularly in biosimilars, which represent a strategic growth avenue amid patent expirations for innovator biologics. Its biosimilar product pipeline includes monoclonal antibodies and growth factors, aiming to capture the expanding biologics segment that is projected to reach $300 billion globally by 2025.[3]

4. Commitment to Quality and Regulatory Compliance

Fresenius Kabi’s emphasis on high safety and efficacy standards enhances its reputation among healthcare providers, especially in highly regulated markets like the EU and North America. Its compliance with global pharmacovigilance frameworks and quality benchmarks positions it as a trusted supplier.

5. Strategic Market Expansion and Collaborations

The company’s proactive market expansion into emerging economies like India and China aligns with global healthcare demand growth. Strategic collaboration with local healthcare players facilitates market access and broadens distribution channels.

Strategic Insights

1. Capitalizing on Critical Care and Oncology Markets

Fresenius Kabi’s entrenched position in critical care, driven by its infusion solutions and cytotoxics, affords it a competitive advantage amid increasing hospital admissions and cancer treatment needs globally. Expanding its oncology portfolio through strategic acquisitions or development of next-generation chemotherapies presents an opportunity for sustained revenue growth.

2. Leveraging Biosimilar Pipelines

The biosimilar segment offers significant margin potential and market penetration opportunities, especially given the patent cliffs of blockbuster biologics. Fresenius Kabi should prioritize advancing its biosimilar development programs and fostering strategic partnerships with biotech firms to accelerate time-to-market and enhance regulatory acceptance globally.

3. Digital Transformation and Supply Chain Optimization

Investing in digital supply chain management platforms can enhance operational agility, improve forecast accuracy, and mitigate global logistical disruptions. Additionally, leveraging real-world evidence and big data analytics can inform R&D and go-to-market strategies.

4. Focused Geographic Expansion

Emerging markets like India, China, and Southeast Asia present high-growth opportunities. Tailoring product portfolios to local needs, navigating regulatory environments efficiently, and forging local partnerships will consolidate Fresenius Kabi’s regional dominance.

5. Emphasizing Sustainability and Corporate Responsibility

Healthcare regulators and consumers increasingly prioritize sustainability. Implementing eco-friendly manufacturing practices, reducing carbon footprint, and ensuring ethical sourcing will enhance brand reputation and future-proof market access.

Competitive Landscape Analysis

Major Competitors

  • Hikma Pharmaceuticals: Focused on generics and biosimilars in the Middle East and North America, Hikma offers intense price competition, particularly in sterile injectables.
  • Baxter International: A direct competitor in infusion therapies and renal care, Baxter’s extensive product portfolio and innovation initiatives challenge Fresenius Kabi’s market share.
  • Fresenius Medical Care: While adjacent, its dominance in dialysis devices poses opportunities for cross-selling biologics and compatible therapies.

Positioning Strategies of Competitors

Competitors emphasize innovation, acquisitions, and digital health integration. Baxter invests heavily in high-margin biologics and advanced infusion technology, targeting hospital procurement channels similar to Fresenius Kabi. Hikma's aggressive pricing and local manufacturing in emerging markets create pressure but also open pathways for strategic differentiation in quality and safety standards.

Market Differentiators

Fresenius Kabi’s key differentiators include:

  • Deep focus on hospital-critical therapies.
  • Presence in highly regulated, hospital-focused supply chains.
  • Continued investments in biosimilars and biologics.
  • Extensive global manufacturing footprint ensuring supply chain resilience.

Implications for Future Strategies

Fresenius Kabi must continue emphasizing product quality, innovation, and regional expansion, particularly in Asia's emerging markets. Developing robust digital tools and maintaining regulatory agility will be critical in staying ahead of competitors and capturing new therapeutic segments.

Key Takeaways

  • Market Leadership in Critical Care & Infusion Therapies: Fresenius Kabi’s entrenched position in hospital-administered medicines provides resilience against market fluctuations and positions it well amid rising global healthcare demands.
  • Biosimilars as Growth Catalyst: With patent expirations for blockbuster biologics, the biosimilar pipeline is vital for future revenue streams. Strategic partnerships and regulatory alignment will expedite growth.
  • Global Manufacturing & Supply Chain Resilience: Its extensive manufacturing capabilities underpin supply stability. Digital supply chain enhancements can further optimize operations.
  • Regional Expansion & Localized Strategies: Targeted growth in emerging markets complements its global footprint, with local partnerships and tailored offerings being pivotal.
  • Innovation & Sustainability: Investment in R&D, coupled with sustainability initiatives, will bolster long-term competitiveness and brand trust.

Conclusion

Fresenius Kabi’s strategic focus on hospital-centric medicines, biosimilars, and global manufacturing positions it favorably within the pharmaceutical landscape. Its commitment to quality, innovation, and regional expansion aligns with evolving healthcare trends and regulatory environments. To sustain competitive advantage, the company must deepen its biosimilar pipeline, leverage digital transformation, and pursue strategic collaborations—especially in emerging markets—thus reinforcing its leadership and fostering sustainable growth.


FAQs

1. How does Fresenius Kabi differentiate itself from competitors?
Fresenius Kabi’s differentiation stems from its hospital-focused product portfolio, extensive manufacturing footprint, prioritization of critical care therapies, and strategic investments in biosimilars, creating a niche in essential, hospital-administered medicines.

2. What growth opportunities exist for Fresenius Kabi in emerging markets?
Emerging markets like China, India, and Southeast Asia present high-growth opportunities through localized manufacturing, tailored product offerings, and strategic partnerships, capitalizing on expanding healthcare infrastructure and rising disease burdens.

3. How significant is biosimilar development in Fresenius Kabi’s strategy?
Biosimilars are central to Fresenius Kabi’s growth outlook, especially as patents for blockbuster biologics expire. They offer higher margins, greater market share, and diversify revenue streams.

4. What challenges does Fresenius Kabi face in the current competitive landscape?
Key challenges include price competition from generics, regulatory hurdles for biosimilars, supply chain disruptions, and the need for continuous innovation to stay ahead of aggressive competitors like Baxter and Hikma.

5. What strategic moves should Fresenius Kabi consider to sustain its market position?
Fresenius Kabi should deepen R&D investments in biosimilars, accelerate digital supply chain initiatives, expand regionally with local partnerships, and prioritize sustainability to reinforce its competitive edge.


Sources

[1] Fresenius Kabi Annual Report 2022.
[2] Company Portfolio and Market Data.
[3] Global Biosimilars Market Report, 2022.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.