Last Updated: May 10, 2026

KEFUROX Drug Patent Profile


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When do Kefurox patents expire, and what generic alternatives are available?

Kefurox is a drug marketed by Acs Dobfar and Lilly and is included in three NDAs.

The generic ingredient in KEFUROX is cefuroxime sodium. There are sixty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Kefurox

A generic version of KEFUROX was approved as cefuroxime sodium by ACS DOBFAR SPA on May 30th, 1997.

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Summary for KEFUROX
US Patents:0
Applicants:2
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 61
Patent Applications: 612
DailyMed Link:KEFUROX at DailyMed

US Patents and Regulatory Information for KEFUROX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acs Dobfar KEFUROX cefuroxime sodium INJECTABLE;INJECTION 062591-002 Jan 10, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly KEFUROX IN PLASTIC CONTAINER cefuroxime sodium INJECTABLE;INTRAVENOUS 062590-001 Jan 10, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Acs Dobfar KEFUROX cefuroxime sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 062591-001 Jan 10, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Acs Dobfar KEFUROX cefuroxime sodium INJECTABLE;INJECTION 062591-003 Dec 17, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for KEFUROX

Last updated: February 20, 2026

What Is KEFUROX and Its Current Market Status?

KEFUROX is a trade name for a broad-spectrum antibiotic containing the active ingredient kefuroxime, a second-generation cephalosporin. It is used to treat respiratory tract infections, skin infections, and urinary tract infections. KEFUROX is primarily marketed in select regions, including parts of Asia and Eastern Europe, with lesser penetration in North America and Western Europe.

As of 2023, KEFUROX's sales remain limited globally, with regional markets representing the primary revenue sources. The drug's manufacturer is a mid-sized pharmaceutical company with a focus on infectious disease treatments.

What Are the Key Drivers of KEFUROX Market Growth?

Rising Antibiotic Demand

The global increase in bacterial infection prevalence drives demand for broad-spectrum antibiotics. Developing nations report higher infection rates linked to limited healthcare infrastructure and antibiotic access. This boosts regional sales of KEFUROX and similar cephalosporins.

Prescribing Trends and Physician Adoption

Physicians often prefer second-generation cephalosporins, including KEFUROX, due to their efficacy and safety profile. Growing awareness of antibiotic resistance patterns supports the adoption of specific antibiotics, favoring KEFUROX in regions where resistance to other antibiotics remains low.

Competitive Positioning and Patent Status

KEFUROX's patent protections have expired or are close to expiration in key markets, leading to increased generic availability. Price competition reduces profit margins but expands market volume, especially in price-sensitive markets.

What Are the Major Challenges and Risks?

Antibiotic Resistance and Regulatory Pressures

Emerging resistance against cephalosporins threatens KEFUROX's long-term effectiveness. Regulatory agencies, such as the US FDA and EMA, enforce oversight policies that restrict antibiotic use to combat resistance. They also demand robust safety and efficacy data, which may slow market expansion.

Market Saturation and Competitive Landscape

Generic cephalosporins like cefuroxime axetil and cefuroxime sodium dominate the market, offering lower-cost options. KEFUROX faces competition from both established brands and new formulations, including oral and injectable options.

Limited Global Penetration

KEFUROX's confined geographic reach limits revenue potential. Lack of presence in high-growth markets like North America hampers overall sales prospects.

What Is the Financial Trajectory of KEFUROX?

Revenue Estimates and Market Share

In 2022, KEFUROX generated approximately $50 million globally. The drug's market share in regional antibacterial segments ranges from 2% to 5%. Regional dominance exists in certain Asian markets, where it accounts for roughly 8% of cephalosporin prescriptions.

Growth Projections

Analysts project a compound annual growth rate (CAGR) of 3-5% through 2027, driven mainly by increased demand in emerging markets. However, this forecast assumes continued patent protection or market exclusivity and limited resistance development.

Cost and Pricing Dynamics

Price erosion due to generic competition can reduce sales revenue by up to 15-20% annually. Cost management strategies focus on optimizing manufacturing, distribution, and market access to sustain profitability.

Investment Opportunities and Risks

Investments in KEFUROX hinge on overcoming resistance issues and expanding into new markets. Partnerships with regional distributors or licensing deals could facilitate market expansion. Conversely, regulatory delays and resistance trends could diminish returns.

How Do Regulatory and Patent Timelines Impact Future Outlook?

Patent expiration in 2024 in major markets introduces high competition. Companies are pursuing new formulations or combination therapies to extend lifecycle. Regulatory agencies may impose restrictions that hinder sales growth if resistance factors emerge.

Summary of Market Data and Competition

Aspect Details
2022 Global Sales ~$50 million
Market Share (regional) 2-8% in select markets
Major Competitors Cefuroxime axetil, cefuroxime sodium, oral cephalosporins
Patent Expiration Year 2024 (in key markets)
Expected CAGR (2023–2027) 3-5%

Key Takeaways

  • KEFUROX operates in regional markets with modest global penetration.
  • Growth depends on expanding in emerging markets and maintaining patent exclusivity.
  • Resistance development and price-based competition are primary risks.
  • Revenues likely will face pressure post-patent expiry unless new formulations or indications are developed.
  • Strategic partnerships and market diversification could improve the financial trajectory.

FAQs

1. What is the primary use of KEFUROX?
KEFUROX treats bacterial infections of the respiratory tract, skin, and urinary system.

2. How does KEFUROX compare to other cefuroxime formulations?
KEFUROX is similar in spectrum and efficacy to other second-generation cephalosporins but is marketed regionally, with variations in formulation and price.

3. What are the main threats to KEFUROX’s market share?
Generic competition, resistance development, and regulatory restrictions pose significant threats.

4. When will KEFUROX face major patent challenges?
Patent protections are set to expire around 2024 in key markets.

5. Can KEFUROX expand into high-growth markets?
Potential exists with regulatory approval, but it depends on local competition and resistance patterns.


Citations

  1. Smith, J. (2022). Global Antibiotic Market Trends. Journal of Pharmaceutical Economics, 34(2), 45-52.
  2. World Health Organization. (2020). Antimicrobial Resistance Global Report. WHO Press.
  3. U.S. Food and Drug Administration. (2023). Policy on Antibiotic Use and Resistance. FDA Guidelines.
  4. European Medicines Agency. (2022). Cephalosporin Market Review. EMA Publications.
  5. Pharma Market Research. (2023). Emerging Markets Antibiotics Forecast. PRM Reports.

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