Last Updated: May 10, 2026

CEFOTETAN Drug Patent Profile


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SponsorPhase
Oregon Health and Science UniversityPHASE2
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

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Pharmacology for CEFOTETAN

US Patents and Regulatory Information for CEFOTETAN

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 CEFOTETAN cefotetan disodium INJECTABLE;INJECTION 065374-001 Aug 9, 2007 AP RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER cefotetan disodium INJECTABLE;INJECTION 065430-001 Aug 9, 2007 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma CEFOTETAN cefotetan disodium INJECTABLE;INJECTION 091031-001 Oct 26, 2011 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 Cefotetan

Last updated: February 20, 2026

What Is Cefotetan?

Cefotetan is a second-generation cephalosporin antibiotic indicated primarily for surgical prophylaxis, intra-abdominal infections, and gynecological infections. It exhibits broad-spectrum activity against gram-positive and gram-negative bacteria, including anaerobes. The drug is administered via intravenous or intramuscular routes.

Global Market Overview

The global demand for cefotetan is driven by surgical procedures, hospital-acquired infections, and antibiotic resistance trends. As of 2022, the global cephalosporin antibiotics market valued at approximately USD 22 billion is projected to grow at a compound annual growth rate (CAGR) of 4.2% until 2030.[1] Cefotetan's share within this segment remains relatively niche but stable due to its specific clinical indications.

Market Players

The primary manufacturers include**

  • Pharmaceutical companies in China and India
  • Limited presence of multinational firms due to generic manufacturing

Major generic producers dominate the supply chain.[2] No recent approvals for new formulations or indications have emerged from top regulatory agencies, which limits export potential.

Regulatory and Patent Landscape

Cefotetan is off-patent. Patent expirations have facilitated generic entry, suppressing prices but increasing market volume. Regulatory agencies such as the FDA and EMA approve cefotetan based on established safety and efficacy profiles. No significant patent applications for modifications or novel delivery systems are observed, constraining innovation-driven market expansion.

Pricing and Revenue Trends

Pricing varies significantly by region, influenced by healthcare infrastructure and reimbursement policies. In the US, average wholesale prices (AWP) for cefotetan are approximately USD 15–20 per vial. The US market alone contributed an estimated USD 50 million in sales in 2022.[3] In Asian markets, price points average USD 5–10 per vial, with higher volumes compensating for lower per-unit revenue.

Market Drivers

  • Increasing surgical procedures globally
  • Rising hospital-acquired infections
  • Expanding antibiotic stewardship programs that favor broad-spectrum agents like cefotetan

Market Challenges

  • Competition from other cephalosporins and antibiotics
  • Growing antibiotic resistance reducing therapeutic utility
  • Regulatory pressure for antimicrobial stewardship leading to restrictions on broad-spectrum antibiotics
  • Limited pipeline innovations, with no new indications or formulations in advanced clinical development

Financial Trajectory Predictions

Revenue for cefotetan is expected to remain stable through 2025, with a compound annual growth rate (CAGR) of 1–2%. Geographic expansion in emerging markets could slightly enhance sales volume. However, pricing pressures, especially in developed regions, are likely to temper revenue growth.

Future Outlook

In the absence of new formulations or marked clinical benefits over existing antibiotics, cefotetan's market position is expected to plateau. Investors and manufacturers should monitor:

  • Antibiotic stewardship trends that may restrict use
  • Emerging resistance patterns diminishing efficacy
  • Potential generic price erosion

Key Takeaways

  • Cefotetan's market is consolidated, driven by generic manufacturing and hospital use.
  • The global market size was valued at roughly USD 50 million in the US in 2022, with steady demand in hospitals.
  • No significant pipeline innovations are under development, constraining future growth.
  • Price sensitivity and resistance development will likely cap revenue expansion.
  • Geographic expansion offers limited upside due to pricing and regulatory hurdles.

FAQs

1. What are the primary clinical indications of cefotetan?
Cefotetan is used for surgical prophylaxis, intra-abdominal infections, and gynecological infections.

2. How does cefotetan compare with other cephalosporins?
It has broad-spectrum activity, including anaerobes, which differentiates it from first-generation cephalosporins.

3. Is there potential for increased market volume?
Yes, particularly via expansion into emerging markets; however, growth is limited by generic competition and stewardship policies.

4. Are there ongoing developments to improve cefotetan?
No significant pipeline innovations or new formulations are publicly reported.

5. How might antibiotic resistance impact cefotetan?
Resistance could reduce effectiveness, leading to decreased use and revenue.

References

[1] MarketsandMarkets. (2022). Cephalosporin Antibiotics Market.
[2] GlobalData. (2022). Generic Drug Market Analysis.
[3] IQVIA. (2023). Pharmaceutical Sales Data.

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