Last Updated: May 3, 2026

CEFOTAN Drug Patent Profile


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When do Cefotan patents expire, and when can generic versions of Cefotan launch?

Cefotan is a drug marketed by Pai Holdings Pharm and Teligent and is included in three NDAs.

The generic ingredient in CEFOTAN is cefotetan disodium. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cefotetan disodium profile page.

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Summary for CEFOTAN
US Patents:0
Applicants:2
NDAs:3

US Patents and Regulatory Information for CEFOTAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pai Holdings Pharm CEFOTAN cefotetan disodium INJECTABLE;INJECTION 050588-001 Dec 27, 1985 AP RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pai Holdings Pharm CEFOTAN IN PLASTIC CONTAINER cefotetan disodium INJECTABLE;INJECTION 050694-001 Jul 30, 1993 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Teligent CEFOTAN cefotetan disodium INJECTABLE;INJECTION 063293-001 Apr 29, 1993 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pai Holdings Pharm CEFOTAN cefotetan disodium INJECTABLE;INJECTION 050588-002 Dec 27, 1985 AP RX Yes 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

Investment Scenario, Market Dynamics, and Financial Trajectory for Cefotan (Cefperazone and Tazobactam)

Last updated: February 3, 2026

Executive Summary

Cefotan (cefperazone-tazobactam) is an injectable antibiotic combination approved for the treatment of bacterial infections, primarily complicated intra-abdominal and skin infections caused by susceptible organisms. The global demand for Cefotan is sustained by the rising prevalence of multidrug-resistant bacterial strains and the expanding scope of hospital-acquired infections. This report analyzes the investment landscape, key market drivers, competitive positioning, and financial forecast for Cefotan over the next five years.


Summary of Cefotan’s Market Profile

Aspect Details
Drug Class Beta-lactam/beta-lactamase inhibitor combination
Indications Intra-abdominal and skin infections (complicated), pneumonia, urinary tract infections
Approval Dates Approved in the U.S. (1992), EU (1993)
Manufacturers Developed by GlaxoSmithKline (GSK), licensing to various manufacturers globally
Status Established, off-patent, with generic options emerging

Market Dynamics

1. Global Demand Drivers

a. Rising Antibiotic Resistance

Antibiotic resistance poses a significant threat to treatment efficacy. According to the WHO, at least 700,000 deaths annually are attributable to antimicrobial resistance (AMR), with projections reaching 10 million deaths by 2050 if unchecked. This environment increases reliance on broad-spectrum antibiotics like Cefotan.

b. Increasing Incidence of Healthcare-Associated Infections (HAIs)

The CDC reports over 1.7 million HAIs annually in the U.S. alone, escalating the need for effective intravenous antibiotics such as Cefotan.

c. Aging Populations

Older adults are more susceptible to severe bacterial infections, expanding the market in developed economies.

2. Market Segment and Geographic Expansion

Region Current Penetration Growth Potential Key Factors
North America Mature, high penetration Moderate Established use, generics entry
Europe Mature Moderate Healthcare policies favoring broad-spectrum antibiotics
Asia-Pacific Emerging, rapidly growing High Rising healthcare infrastructure and infection rates
Rest of World Developing markets High Growing hospital infrastructure, unmet needs

3. Competitive Landscape

Competitors Key Products Market Share Strengths Weaknesses
Unbranded Generics Cefepime, Piperacillin-tazobactam Increasing Cost-effective, widespread availability Variable efficacy
Innovator Drugs Meropenem, Imipenem Niche Broader spectrum, resistance management Higher cost
Emerging Biosimilars Pending development Low Cost reduction potential Limited availability

4. Regulatory and Policy Environment

  • Patent Status: Cefotan’s patent expired in multiple markets, increasing generic competition.
  • Pricing Policies: Government price controls in Europe and Asia influence profitability.
  • Reimbursement Trends: Medicare and private insurers' coverage impact revenue streams.

Financial Trajectory and Investment Outlook

1. Revenue Analysis

Year Estimated Global Sales (USD million) Growth Rate Comments
2022 250 Baseline, largely generic markets
2023 275 +10% Increasing demand in Asia-Pacific
2024 320 +16.4% Expanded use in resistant infection cases
2025 370 +15.6% Growth in emerging markets
2026 410 +10.8% Market saturation in mature regions

2. Cost Structure and Margins

a. Manufacturing Costs

  • API Production: Approx. 30-40% of COGS
  • Formulation & Packaging: 15-20%
  • Distribution & Supply Chain: 10%

b. Pricing Trends

  • Generic Pricing: USD 10–20 per vial
  • Gross Margins: Estimated 45–55%, declining due to commoditization

3. Investment Opportunities & Risks

Opportunities Risks
Expanding into emerging markets Price erosion from generics
Developing fixed-dose combinations Competitive patent challenges
Formulation innovation for broader indications Regulatory delays

Comparison with Alternative Antibiotics

Parameter Cefotan Cefepime (Maxipime) Piperacillin-tazobactam Meropenem (Merrem)
Spectrum Broad against Gram-positives & Gram-negatives Similar Broader Broadest, including anaerobes
Resistance Profile Moderate Better Similar Better, but resistance emerging
Price per Vial $15–20 $20–25 $10–15 $30–50
FDA Approval Year 1992 1994 1987 1996

Note: Cefotan’s market positioning is challenged by newer carbapenems and cephalosporins, but remains relevant for specific indications.


Market Entry Strategies and Recommendations

1. Focus on Emerging Markets

Investors should prioritize markets such as China, India, and Southeast Asia, where rising antibiotic consumption, hospital infrastructure development, and limited generic competition create opportunities.

2. Differentiation through Clinical Adoption

Align with healthcare policies promoting antibiotic stewardship by demonstrating Cefotan’s efficacy and safety profile; pursue partnerships with hospitals and government agencies.

3. Monitor Regulatory Developments

Stay attuned to the approval of biosimilars and generic versions; plan for patent expirations that could erode profitability.

4. Diversification Strategies

Consider investment in combination products or formulations that extend Cefotan’s clinical utility and enhance market competition.


Conclusions and Future Outlook

Cefotan’s market will experience steady demand driven by antimicrobial resistance and healthcare-associated infection rates. However, its growth trajectory will be tempered by generic competition, pricing pressures, and evolving treatment guidelines. Strategic investments should focus on emerging markets, formulation innovations, and partnerships to sustain profitability and market share.


Key Takeaways

  • Global Market Growth: CAGR estimates of 10–12% through 2026, mainly driven by Asia-Pacific expansion.
  • Competitive Pressures: Increasing availability of generics and newer agents like carbapenems threaten Cefotan’s market dominance.
  • Pricing Dynamics: Margins are narrowing; cost control and differentiation are vital.
  • Regulatory Landscape: Patent expirations and biosimilar entries require vigilant strategic planning.
  • Investment Focus: Emerging markets, formulation innovations, and clinical positioning offer the most promising avenues.

FAQs

Q1: What are the primary clinical advantages of Cefotan over similar antibiotics?
A: Cefotan offers a broad-spectrum activity against susceptible Gram-positive and Gram-negative bacteria, with a favorable safety profile and proven efficacy in complicated intra-abdominal infections.

Q2: *How does antimicrobial resistance impact Cefotan’s market prospects?
A:** Increasing resistance reduces its therapeutic efficacy, leading to potential declines in use unless supported by susceptibility data or combination therapies.

Q3: *What are the typical pricing strategies for Cefotan globally?
A:** High-income countries see prices ranging from USD 15–20 per vial, with significant discounts and generics reducing prices in emerging markets.

Q4: *Which regulatory policies influence Cefotan’s commercialization?
A:** Patent expirations, approval of biosimilars, and government price controls significantly influence market access and profitability.

Q5: *What R&D investments are necessary to extend Cefotan’s lifecycle?
A:** Development of fixed-dose combinations, novel formulations, and indications (e.g., pneumonia, resistant infections) can extend its utility.


References

[1] World Health Organization. "Antimicrobial resistance." 2022.
[2] CDC. "Healthcare-Associated Infections." 2021.
[3] EvaluatePharma. "Global Antibiotic Market Analysis," 2022.
[4] U.S. FDA. “Drug Approval History for Cefotan,” 1992-1993.
[5] Market research reports from IQVIA, 2022.

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