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Last Updated: December 15, 2025

Ceforanide - Generic Drug Details


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What are the generic drug sources for ceforanide and what is the scope of freedom to operate?

Ceforanide is the generic ingredient in one branded drug marketed by Apothecon and Bristol, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for ceforanide.

Summary for ceforanide
US Patents:0
Tradenames:1
Applicants:2
NDAs:2
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 55
DailyMed Link:ceforanide at DailyMed

US Patents and Regulatory Information for ceforanide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol PRECEF ceforanide INJECTABLE;INJECTION 050554-004 May 24, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Apothecon PRECEF ceforanide INJECTABLE;INJECTION 062579-002 Nov 26, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bristol PRECEF ceforanide INJECTABLE;INJECTION 050554-001 May 24, 1984 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

Market Dynamics and Financial Trajectory of Ceforanide

Last updated: August 4, 2025

Introduction

Ceforanide, a third-generation cephalosporin antibiotic, emerges as a potent agent addressing severe bacterial infections, particularly in hospital settings. Although not as commercially prominent as other cephalosporins, understanding its market dynamics and potential financial trajectory offers vital insights for pharma stakeholders. This analysis delineates the factors influencing Ceforanide’s market position, assesses its current and projected financial landscape, and evaluates strategic avenues within the evolving antimicrobial domain.

Pharmacological Profile and Therapeutic Indications

Ceforanide functions by inhibiting bacterial cell wall synthesis, exhibiting broad-spectrum activity against Gram-positive and Gram-negative bacteria. Its clinical indications predominantly include complicated urinary tract infections, respiratory infections, and meningitis, often reserved for hospital-based treatment due to administration requirements and spectrum potency. The drug’s pharmacokinetics favor intravenous infusion, aligning with inpatient care strategies.

Current Market Landscape

1. Competitive Position and Market Penetration

Ceforanide’s market share remains modest relative to dominant third-generation cephalosporins like ceftriaxone and ceftazidime, which benefit from broader manufactured volumes, extensive clinical evidence, and established distribution channels. Its limited global commercial footprint stems from:

  • Manufacturing Challenges: Ceforanide’s synthesis involves complex processes, elevating production costs.
  • Limited Formulation Variants: Fixed-dose formulations are scarce, restricting flexibility.
  • Regulatory Approvals: As a niche drug, Ceforanide holds approvals primarily in select markets, notably certain Asian and Eastern European countries, constraining global reach.

2. Market Drivers and Barriers

Drivers:

  • Rising antimicrobial resistance (AMR) prompts clinicians to seek novel or less-utilized antibiotics like Ceforanide.
  • Institutional protocols favoring potent, broad-spectrum agents for severe infections may temporarily bolster demand.
  • Emerging hospital-centric infection control measures could favor drugs with proven efficacy.

Barriers:

  • Stringent antimicrobial stewardship policies discourage broad use of potent antibiotics to mitigate resistance development.
  • The emergence of newer cephalosporins with enhanced safety profiles or broader activity limits Ceforanide’s appeal.
  • Competition from generic formulations of established antibiotics reduces pricing power and profit margins.

3. Regulatory and Patent Status

Ceforanide’s patent landscape is mature, with patents either expired or nearing expiry in key markets, prompting impending generic entry. Regulatory pathways are complex but manageable within countries with established approval records, although the lack of recent clinical trials curtails recent regulatory incentives.

Future Market Dynamics

1. Antimicrobial Resistance and Clinical Need

An escalating global crisis of antimicrobial resistance heightens demand for potent agents. Ceforanide’s activity profile may position it as an alternative to more resistance-prone cephalosporins, especially in settings with multi-drug resistant pathogens. However, its niche positioning limits large-scale adoption without targeted clinical trials demonstrating superiority or safety advantages.

2. Innovation and Drug Development Trends

Antibiotic development faces sustainability challenges, with prolific pipelines focused on novel mechanisms, beta-lactamase inhibitors, and combination therapies. Ceforanide’s role may be redefined if it becomes part of combination regimens or innovatively reformulated (e.g., sustained-release formulations) to improve efficacy or ease of use.

3. Market Potential in Emerging Economies

Growing healthcare infrastructure and the rise of hospital-acquired infections in emerging markets could create localized demand. Governmental and institutional procurement strategies might favor established, cost-effective antibiotics, but price-sensitive markets pose challenges.

4. Impact of Generics and Market Saturation

Patent expiration portends increased generic competition, pressuring prices downward. Margins are likely to decline unless Ceforanide gains a differentiation factor such as superior efficacy, safety, or cost-effectiveness.

Financial Trajectory and Investment Outlook

1. Revenue Projections

Given the drug's niche positioning, current revenues are limited. The future trajectory hinges on several factors:

  • Market acceptance and clinical trial evidence: Expansion hinges on demonstrating clinical advantages.
  • Pricing strategies: Maintaining profitability in the face of generic competition requires value-based pricing or licensing innovations.
  • Geographic expansion: Entry into developing markets can marginally uplift revenues, especially if tailored to local resistance patterns.

2. Investment and R&D Potential

Pharmaceutical companies may allocate R&D resources toward Ceforanide’s development if they see potential in rebranding or repositioning it within combination therapies or specialized treatment niches. However, the overall R&D investment outlook remains cautious given shifting focus toward broader-spectrum, innovative antibiotics.

3. Strategic Considerations

  • Partnerships and Licensing: Collaborations with local generic producers or biotech firms can extend market reach.
  • Regulatory Incentives: Leveraging accelerated approval pathways or orphan drug statuses in certain jurisdictions might temporarily boost market exclusivity.
  • Manufacturing Optimization: Streamlining synthesis processes can mitigate costs and improve margin prospects.

Conclusion

Ceforanide’s market dynamics reflect a complex interplay of antimicrobial resistance trends, clinical needs, regulatory landscapes, and competitive forces. Its future financial trajectory will likely be characterized by modest growth, primarily driven by niche applications and emerging markets, unless strategic innovations or clinical breakthroughs elevate its position. The industry’s pivot toward novel agents diminishes the prospects of significant revenue expansion absent differentiation.


Key Takeaways

  • Niche Positioning: Ceforanide plays a limited but potentially strategic role in severe bacterial infections, especially where resistance impairs other cephalosporins.
  • Market Challenges: Competitive pressures, generic erosion, and regulatory barriers constrain growth prospects.
  • Emerging Opportunities: Rising antimicrobial resistance and hospital infection trends suggest possible localized demand; however, broad-scale expansion demands clinical validation and innovation.
  • Strategic Focus: Partnerships, cost-effective manufacturing, and targeted regulatory strategies can enhance Ceforanide’s financial trajectory.
  • Long-term Outlook: Without significant repositioning or clinical breakthroughs, Ceforanide’s revenue potential remains modest within the global antibiotic market.

FAQs

Q1: What are the primary clinical indications for Ceforanide?
Ceforanide is primarily indicated for complicated urinary tract infections, respiratory tract infections, and meningitis caused by susceptible bacteria.

Q2: How does Ceforanide compare with other third-generation cephalosporins in the market?
It has a narrower market presence, with fewer formulations and less widespread approval, limiting its use relative to ceftriaxone or ceftazidime, which boast broader indications and global distribution.

Q3: What are the main barriers to Ceforanide’s market expansion?
Manufacturing complexity, limited clinical data, competition from established antibiotics, and patent expiry leading to generic competition are key barriers.

Q4: Could antimicrobial resistance trends positively impact Ceforanide’s demand?
Potentially, yes. As resistance rises, clinicians may seek alternative agents like Ceforanide if proven effective against resistant strains, but this requires clinical validation and regulatory approval.

Q5: What strategic steps can maximize Ceforanide’s market potential?
Forming strategic partnerships, innovating formulations or combination therapies, targeting emerging markets, and leveraging regulatory incentives can enhance its market outlook.


References:

[1] World Health Organization. (2021). Antimicrobial resistance.
[2] IMS Health Data. (2022). Global antimicrobial market analysis.
[3] FDA and EMA approval databases.
[4] MarketWatch. (2023). Antibiotics market trends and forecasts.
[5] Patent and regulatory filings in key markets.

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