ceforanide - Profile

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.

Summary for ceforanide

US Patents:	0
Tradenames:	1
Applicants:	2
NDAs:	2

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
Apothecon	PRECEF	ceforanide	INJECTABLE;INJECTION	062579-002	Nov 26, 1984		DISCN	No	No
Apothecon	PRECEF	ceforanide	INJECTABLE;INJECTION	062579-003	Nov 26, 1984		DISCN	No	No
Apothecon	PRECEF	ceforanide	INJECTABLE;INJECTION	062579-004	Nov 26, 1984		DISCN	No	No
Apothecon	PRECEF	ceforanide	INJECTABLE;INJECTION	062579-005	Nov 26, 1984		DISCN	No	No
Apothecon	PRECEF	ceforanide	INJECTABLE;INJECTION	062579-001	Nov 26, 1984		DISCN	No	No
Bristol	PRECEF	ceforanide	INJECTABLE;INJECTION	050554-002	May 24, 1984		DISCN	No	No
Bristol	PRECEF	ceforanide	INJECTABLE;INJECTION	050554-003	May 24, 1984		DISCN	No	No

Summary
Ceforanide, a cephalosporin antibiotic, presents limited commercial prospects due to its age, narrow spectrum, and lack of recent clinical development. Its investment potential is constrained; however, understanding its market position and development status aids strategic decisions.

What is Ceforanide?
Ceforanide is a second-generation cephalosporin antibiotic used predominantly in patients with bacterial infections resistant to first-generation agents. Developed in the 1980s, it is administered via injection, targeting respiratory, urinary, and skin infections. Commercialized mainly in Japan and select European markets, it has minimal global penetration.

Market Overview and Demand Dynamics

• Global Antibiotic Market Size: Estimated at $45.7 billion in 2022, expected to grow at a CAGR of 3.5% through 2030 [1].
• Cephalosporin Segment: Represents roughly 35% of total antibiotic sales, dominated by broad-spectrum agents such as ceftriaxone and cefepime.
• Ceforanide's Market Share: Marginal, with small sales volumes primarily in Asian markets. No recent data indicate significant growth or re-entry efforts.

Regulatory and Patent Landscape

• Regulatory Status: Limited regulatory activity; no recent patent filings globally. Original patents likely expired in the early 2000s, opening the market to generics.
• Patent Closures: Generic development is feasible, leading to price erosion and diminished profitability potential.

Competitive Position and Alternatives

Last updated: February 13, 2026

• Key Competitors: Ceftriaxone, cefepime, cefoxitin, and other second-generation cephalosporins dominate. These agents are preferred because of broader activity, dosing convenience, and established safety profiles.
• Advancements: Newer antibiotics with enhanced efficacy and spectrum are in advanced development stages or have regulatory approval, reducing ceforanide's relevance.
• Resistance Concerns: Rising antibiotic resistance favors broader-spectrum agents, reducing ceforanide's appeal.

Development and R&D Considerations

• Clinical Development Needs: To regain market share, extensive clinical trials demonstrating superiority or unique benefits are required. Costs are high, and the likelihood of differentiation is low.
• Market Entry Barriers: Existing generics, established treatment guidelines, and minimal unmet needs hamper opportunities for reintroduction.

Financial and Investment Outlook

Factor	Impact	Comment
Development Cost	High	Rebranding or reformulation demands large R&D investments.
Market Size	Small	Limited sales volume due to competition and market saturation.
Regulatory Pathway	Complex	No recent filings; pathway uncertain without new data.
Competitive Landscape	Crowded	Dominated by well-established, broad-spectrum agents.
Pricing Potential	Low	Competition drives down prices in established markets.

Strategic Alternatives

• Niche Development: Focus on regions with limited access to broad-spectrum agents or where ceforanide's specific activity profile remains relevant.
• Combination Therapy: Investigate utility in combination with other antibiotics for resistant strains.
• Drug Repurposing: Explore non-antibiotic indications if emerging data supports such use, though no current evidence exists.

Conclusion

Ceforanide presents minimal investment appeal based on current market conditions. Its advanced age, generic availability, and fierce competition diminish prospects for significant revenue generation. Market entry or revitalization would require substantial innovation and strategic positioning, with high risk of low return.

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Key Takeaways

• Ceforanide is an older, limited-use cephalosporin with negligible current market activity.
• The global antibiotic market is growing modestly, with expanding preferences toward broad-spectrum agents.
• Patent expirations and generic competition reduce pricing power and profitability.
• Significant R&D investment would be needed to reintroduce or reposition ceforanide, with uncertain prospects.
• Focus on niche or combination therapies might offer marginal opportunities but are unlikely to alter its fundamentally limited outlook.

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FAQs

1. Is there any recent clinical development for ceforanide?
No, ceforanide has not undergone recent clinical trials, and no new regulatory filings or approvals have been reported.

2. Are there geographic markets where ceforanide remains relevant?
Its usage persists in some Asian countries, but sales are minimal and declining due to competition and generics.

3. Could ceforanide be repositioned for new indications?
No substantial evidence supports alternative uses; development for new indications would require extensive research and may not be commercially viable.

4. What are the primary competitors to ceforanide?
Ceftriaxone and cefepime dominate second-generation cephalosporin sales, offering broader activity and established safety profiles.

5. What is the outlook for cephalosporin antibiotics in general?
While demand persists for antibiotics, rising resistance and new drug development trends favor novel agents over traditional, older drugs like ceforanide.

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Sources
[1] MarketsandMarkets. “Antibiotics Market by Type.” 2022.