Last Updated: June 10, 2026

Cefonicid sodium - Generic Drug Details


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What are the generic drug sources for cefonicid sodium and what is the scope of patent protection?

Cefonicid sodium is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for cefonicid sodium
US Patents:0
Tradenames:1
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 44
DailyMed Link:cefonicid sodium at DailyMed
Medical Subject Heading (MeSH) Categories for cefonicid sodium

US Patents and Regulatory Information for cefonicid sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline MONOCID cefonicid sodium INJECTABLE;INJECTION 050579-003 May 23, 1984 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline MONOCID cefonicid sodium INJECTABLE;INJECTION 063295-001 Jul 26, 1993 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline MONOCID cefonicid sodium INJECTABLE;INJECTION 050579-004 May 23, 1984 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline MONOCID cefonicid sodium INJECTABLE;INJECTION 050579-002 May 23, 1984 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline MONOCID cefonicid sodium INJECTABLE;INJECTION 050579-001 May 23, 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

Cefonicid Sodium: Market Dynamics and Financial Trajectory

Last updated: February 20, 2026

What Is Cefonicid Sodium and Its Clinical Use?

Cefonicid sodium is a second-generation cephalosporin antibiotic marketed for treating bacterial infections. It has activity against gram-positive bacteria, including staphylococci and streptococci, as well as some gram-negative bacteria like E. coli, Proteus mirabilis, and Klebsiella species. It is administered intravenously or intramuscularly for indications such as urinary tract infections, skin infections, and postoperative infections.

Market Landscape and Competitive Position

Cefonicid sodium's market presence is limited relative to newer cephalosporins due to factors such as:

  • Patent status: Many formulations are off-patent globally, leading to generic competition.

  • Regulatory approvals: Approved in select markets, including China, Russia, and some Southeast Asian countries. Not widely approved in the US or Europe.

  • Market share: Small compared to broad-spectrum, advanced antibiotics like ceftriaxone, cefepime, and carbapenems.

The drug competes mainly with other second-generation cephalosporins such as cefuroxime and cefoxitin, which have broader acceptance and more extensive approved indications. Its niche focus limits sales volume.

Supply Chain and Manufacturing Factors

Cefonicid sodium is produced by a handful of manufacturers primarily in China, India, and Russia. Suppliers of active pharmaceutical ingredients (APIs) report consistent but declining demand because of the shift toward newer agents. Production costs are stable but face pressure from generic competition leading to reduced margins.

Regulatory and Patent Dynamics

Most formulations are off-patent worldwide. The expiration of basic patents in the early 2000s led to proliferation of generics. Future approvals for biosimilars or better formulations are unlikely, as the compound has largely been phased out from modern clinical use in favor of newer antibiotics.

Market Drivers and Restraints

Driving Factors:

  • Rising bacterial resistance calls for alternative antibiotics in developing regions.
  • Use in hospitals with established supply chains for injectable antibiotics.
  • Demand for affordable antibiotics in emerging markets.

Restraints:

  • Limited spectrum compared to newer cephalosporins.
  • Regulatory restrictions in major markets like North America and Europe.
  • Shift toward oral agents and antibiotics with broader safety profiles.

Revenue Projections and Financial Trajectory

Historical Financial Data:

  • Average annual sales: Estimated globally at $50–70 million (2018–2022), mainly from Asian markets.
  • Market concentration: The top three suppliers hold >70% of global sales.
  • Price erosion: Approximately 10–15% annually since 2015 due to generic competition.

Future Outlook:

Segment Projection (2023–2028)
Sales Volume Slight decline rates of 1–3% annually as usage stabilizes or declines.
Market Value Expected to decrease by 5–10% annually driven by price competition and regulatory barriers.
Key Markets China, Russia, Southeast Asia will account for 85% of sales, with minimal growth expected outside these regions.

Financial Risks:

  • These include generic pricing pressures and regulatory restrictions.
  • Supply chain disruptions are manageable due to multiple regional manufacturing sites.
  • Limited competition from newer agents constrains potential growth.

Strategic Considerations

  • Market longevity remains uncertain given global trends favoring broad-spectrum, oral, or newer antibiotics.
  • Opportunities exist in specific hospital settings and developing markets.
  • Rationalization of manufacturing capacity may lead to further price declines.

Key Takeaways

  • Cefonicid sodium holds a minor market niche dominated by generics in select countries.
  • Market sales decline driven by competition, regulatory regional restrictions, and shifts toward modern antibiotics.
  • Revenue estimates forecast a gradual decrease at 5–10% annually over the next five years.
  • Major markets are China, Russia, and Southeast Asia; Latin America and Africa present limited growth potential.
  • Investment or R&D prospects are limited, with little innovation in this class.

FAQs

1. Why has cefonicid sodium lost market share?
It has been supplanted by newer cephalosporins with broader activity, better safety profiles, and more convenient administration.

2. Are there any ongoing R&D efforts to improve or reformulate cefonicid sodium?
Currently, no significant R&D initiatives target cefonicid sodium due to limited clinical advantages and market withdrawal.

3. Which markets contribute most to cefonicid sodium sales?
China, Russia, and Southeast Asian countries are the primary markets.

4. What are the key risks facing the cefonicid sodium market?
Patent expirations, competition from generics, regulatory restrictions, and the decline in clinical preference for older antibiotics.

5. Is cefonicid sodium a viable candidate for combination therapy?
Limited data and declining use reduce the attractiveness of cefonicid sodium for combination therapies.


References

[1] MarketWatch. (2022). Global cephalosporin antibiotics market.
[2] GlobalData. (2023). Antibiotics market analysis, 2023.
[3] U.S. Food & Drug Administration. (2021). Approved antimicrobial drugs.
[4] Chinese National Medical Products Administration. (2022). Approved antibiotics.
[5] European Medicines Agency. (2022). Summary of medicinal product characteristics.

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