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Last Updated: March 27, 2026

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 050554-003 May 24, 1984 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apothecon PRECEF ceforanide INJECTABLE;INJECTION 062579-005 Nov 26, 1984 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apothecon PRECEF ceforanide INJECTABLE;INJECTION 062579-004 Nov 26, 1984 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apothecon PRECEF ceforanide INJECTABLE;INJECTION 062579-002 Nov 26, 1984 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol PRECEF ceforanide INJECTABLE;INJECTION 050554-005 May 24, 1984 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

Ceforanide Market Dynamics and Financial Trajectory

Last updated: February 20, 2026

What is the current market position of ceforanide?

Ceforanide is a third-generation cephalosporin antibiotic primarily used for treating resistant bacterial infections. It is marketed in specific regions, notably South Korea and some Asian markets, with limited global distribution. The drug's availability is constrained by its regional approval status and competition from broader-spectrum antibiotics.

How is ceforanide positioned within the global antibiotic market?

Factor Details
Regulatory approvals Approved in South Korea, limited approvals elsewhere
Market share Estimated less than 1% of the broad cephalosporin segment
Manufacturing Produced by Hanmi Pharmaceutical (South Korea)
Primary competitors Ceftriaxone, cefotaxime, ceftazidime

Ceforanide targets a niche segment within hospital settings for resistant infections, such as complicated urinary tract infections and pneumonia. Given regional approval and limited worldwide registration, its market share remains small.

What are the key factors influencing ceforanide’s market growth?

Regional approvals and clinical indications

Limited approvals restrict the expansion outside South Korea, where the regulatory environment permits its use for specific indications. The drug's market growth hinges on gaining approvals elsewhere and demonstrating clinical advantages over existing options.

Competitive landscape

Ceforanide faces competition from well-established third-generation cephalosporins like ceftriaxone and cefotaxime. These antibiotics have broader approval, widespread use, and manufacturing economies of scale, making market penetration of ceforanide challenging.

Resistance trends

Rising bacterial resistance to older cephalosporins increases demand for advanced options. However, evidence of ceforanide’s superior efficacy and safety is limited, preventing significant market expansion.

Pricing and reimbursement

Pricing strategies are region-dependent. In South Korea, reimbursement policies favor established drugs. Ceforanide’s pricing aligns with niche antibiotic products, limiting revenue potential.

What are the financial prospects for ceforanide?

Revenue estimates

Given its limited use, global annual sales likely stay below $10 million, primarily driven by South Korea. Market growth depends on approval expansion and clinical adoption.

R&D and regulatory costs

Investment in trials for new indications or regional approvals is estimated at $5-10 million per regional submission. These costs influence the profitability of expanding usage.

Investment risk

High, due to limited global demand, regulatory hurdles, and intense competition from generic formulations of key antibiotics. Market expansion requires significant clinical and regulatory effort, with uncertain financial returns.

What are the future dynamics influencing ceforanide’s trajectory?

  • Regulatory Approvals: Gaining approvals in North America and Europe could increase access but faces long, expensive approval processes.
  • Development of Resistance: Rising resistance could renew interest in newer antibiotics, but current data do not favor ceforanide’s dominance.
  • Regional Market Trends: The Asia-Pacific market remains the primary growth area; regional policies and healthcare infrastructure will shape sales.
  • Generic Competition: The availability of generics for major cephalosporins exerts downward pressure on price and margins.

How do regional healthcare policies impact ceforanide’s prospects?

In South Korea, government support and hospital procurement practices facilitate ceforanide’s use. Elsewhere, approval delays and reimbursement issues serve as barriers, limiting market expansion.


Key Takeaways

  • Ceforanide holds a niche position, with limited global distribution primarily in South Korea.
  • Market growth relies heavily on regional regulatory approvals and clinical adoption.
  • Competition from broad-spectrum cephalosporins suppresses its market share.
  • Financial prospects remain modest, with revenue under $10 million annually outside South Korea.
  • Expansion is hindered by regulatory, competitive, and reimbursement challenges.

FAQs

1. Can ceforanide become a global standard treatment?
Unlikely without significant clinical data supporting superiority and international regulatory approvals.

2. What are the main competitors to ceforanide?
Ceftriaxone, cefotaxime, and ceftazidime, which have broader approvals and widespread use.

3. Is ceforanide suitable for multi-drug resistant infections?
Its efficacy against resistant strains is not well established; newer drugs may be preferred.

4. What is the potential for ceforanide in the upcoming antibiotic pipeline?
Limited, due to its small market share and competition from newer, more versatile antibiotics.

5. How does regional approval impact ceforanide’s revenue?
Approval in a region limits sales to that geographic market; expanding approval increases revenue but involves high costs.


References

  1. Hanmi Pharmaceutical. (2022). Ceforanide development and approval status. Retrieved from https://www.hanmi.com
  2. World Health Organization. (2021). Global antimicrobial resistance surveillance report.
  3. MarketWatch. (2022). Antibiotics market size and forecasts.
  4. U.S. Food and Drug Administration. (2020). Drug approval process.
  5. European Medicines Agency. (2021). Antibiotics approvals and policies.

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