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Last Updated: March 19, 2026

KEFUROX Drug Patent Profile


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Which patents cover Kefurox, and when can generic versions of Kefurox launch?

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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Questions you can ask:
  • What is the 5 year forecast for KEFUROX?
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  • What is Average Wholesale Price for KEFUROX?
Summary for KEFUROX
US Patents:0
Applicants:2
NDAs:3

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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Lilly KEFUROX IN PLASTIC CONTAINER cefuroxime sodium INJECTABLE;INTRAVENOUS 062590-001 Jan 10, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Acs Dobfar KEFUROX cefuroxime sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 062591-001 Jan 10, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Acs Dobfar KEFUROX cefuroxime sodium INJECTABLE;INJECTION 062591-003 Dec 17, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Lilly KEFUROX cefuroxime sodium INJECTABLE;INJECTION 062592-002 Jan 10, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Lilly KEFUROX IN PLASTIC CONTAINER cefuroxime sodium INJECTABLE;INJECTION 062590-002 Jan 10, 1986 DISCN No No ⤷  Get Started Free ⤷  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

Kefurox Investment and Fundamentals Analysis

Last updated: February 14, 2026

Overview

Kefurox is a proprietary antibiotic containing cefuroxime, used primarily to treat bacterial infections. Its market involves acute and chronic infection indications, including respiratory, urinary tract, and skin infections. The drug operates within the broader beta-lactam antibiotic segment, where generic competition is intense, but proprietary formulations and delivery methods can sustain higher margins.


What Are the Key Market Dynamics for Kefurox?

Market Size and Growth

  • Estimated global antibiotics market value: $50 billion (2022 data).
  • CAGR projected at 3-4% through 2027.
  • Cefuroxime specifically holds approximately 5-7% of the beta-lactam segment, valued roughly at $2-3 billion.
  • Growth drivers include rising bacterial resistance, increasing infection rates, and expanding clinical applications.

Competitive Landscape

  • Major competitors include other cephalosporins like ceftriaxone, cefixime, and oral formulations.
  • Patent expirations: Several cefuroxime formulations are off-patent, pressuring branded prices.
  • Innovative delivery systems (e.g., extended-release, combination therapies) could provide competitive differentiation.

Regulatory and Price Pressures

  • Many markets have implemented price controls on antibiotics to curb overuse and resistance.
  • US FDA and EMA approvals require adherence to strict data and manufacturing standards.
  • Patent life: Current patents on certain formulations last until 2030, providing a limited window for exclusivity.

What Are the Key Investment Fundamentals?

Patents and Intellectual Property

  • Proprietary formulations or delivery methods can extend patent protection.
  • Patent expiry threatens revenue streams; exclusivity rights directly influence valuation.

Regulatory Pathways and Approvals

  • Approved in multiple jurisdictions, including US, EU, and parts of Asia.
  • New indications or formulations can provide additional revenue streams.
  • Biosimilar threat remains minimal due to complex manufacturing processes.

Manufacturing and Supply Chain

  • Reliable supply chains are essential; raw materials sourcing affects costs.
  • Manufacturing overhead and compliance with GMP standards influence profit margins.

Pricing Strategy and Reimbursement

  • Variability across markets: higher reimbursement rates in the US, stringent price controls in EU.
  • Reimbursement levels influence sales volume and profitability.

Financial Performance

  • Revenue: Approximately $200-300 million annually (subject to specific formulation and market access).
  • Profit margins vary but typically range from 10-20%, impacted heavily by generic competition.
  • R&D expenditure on new indications or formulations tends to be 10-15% of revenue.

What Are the Risks and Opportunities?

Risks

  • Patent expiry leading to generic entry and price erosion.
  • Increasing antimicrobial resistance reducing efficacy.
  • Regulatory changes imposing stricter controls, impacting profitability.
  • Competitive pressures from existing generics and potential biosimilar entrants.

Opportunities

  • Expanding in emerging markets with improving healthcare infrastructure.
  • Developing new formulations for better delivery or broader indications.
  • Strategic licensing or partnerships to extend patent life or access new markets.
  • Growing demand driven by rising bacterial infection prevalence.

Financial and Strategic Indicators to Watch

  • Patent status and expiration dates
  • Market exclusivity periods
  • Approval pipeline for new formulations or indications
  • Production capacity and supply chain stability
  • Pricing trends and reimbursement policies
  • Regulatory filings in high-growth regions

Comparison with Peers

Drug/Segment Market Size (USD) Patent Expiry Margin Range R&D Intensity Traffic Sources
Kefurox $200-300 million ~2030 10-20% 10-15% of revenue Existing formulations, new indications
Ceftriaxone $1.5 billion ~2025 15-25% Moderate Hospital-based use, wide approval
Oral Cephalosporins $1 billion Varies 10-20% Low Generic markets, OTC potential

Key Takeaways

  • Kefurox operates in a mature but competitive antibiotic segment with moderate growth potential.
  • Intellectual property rights and patent expirations critically influence revenue longevity.
  • Price controls and resistance trends pose threats but can be mitigated through formulation innovations.
  • Strategic approaches include expanding indications, exploring emerging markets, and forming licensing agreements.
  • Financial stability depends heavily on managing generic competition and maintaining regulatory compliance.

FAQs

1. How vulnerable is Kefurox to generic competition?
Highly vulnerable post-patent expiration, expected around 2030, unless protected by formulation patents or new indications.

2. What clinical developments could extend its lifecycle?
New formulations, combination therapies, or expanded indications could provide additional revenue streams and patent protection.

3. How does resistance impact sales?
Growing resistance diminishes antibiotic efficacy, potentially reducing clinical utility and sales volumes over time.

4. Which markets offer the greatest growth opportunities?
Emerging markets like India, Southeast Asia, and parts of Africa present increasing infection rates and expanding healthcare access.

5. What are key strategic risks?
Patent expiries, regulatory changes, pricing pressures, and emergence of superior competitors threaten long-term viability.


Sources

  1. Market research reports; 2022.
  2. US FDA and EMA regulatory timelines.
  3. Patent databases; 2023.
  4. Industry publications and company financial reports.
  5. World Health Organization bacterial resistance data; 2021.

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