Last Updated: May 3, 2026

CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Cephalothin Sodium W/ Sodium Chloride In Plastic Container, and what generic alternatives are available?

Cephalothin Sodium W/ Sodium Chloride In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER is cephalothin sodium. There are seven drug master file entries for this compound. Additional details are available on the cephalothin sodium profile page.

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Summary for CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER
Recent Clinical Trials for CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Instituto Mexicano del Seguro SocialPhase 3
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER cephalothin sodium INJECTABLE;INJECTION 062422-001 Jan 31, 1984 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER cephalothin sodium INJECTABLE;INJECTION 062422-002 Jan 31, 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

Market Dynamics and Financial Trajectory for Cephalothin Sodium with Sodium Chloride in Plastic Container

Last updated: February 21, 2026

What is the current market landscape for cephalothin sodium formulations?

Cephalothin sodium, a first-generation cephalosporin antibiotic used in treating bacterial infections, sees limited but stable demand primarily within hospital environments, especially in regions with older healthcare infrastructure. Its form combined with sodium chloride in plastic containers suggests a focus on ready-to-administer solutions, common in sterile clinical settings.

Market Size and Growth:
Globally, the cephalosporin market was valued at approximately USD 12 billion in 2022, with antibiotics like cephalothin maintaining a niche segment due to its age and spectrum. The overall growth rate for cephalothin specifically remains low, around 1-3% annually, constrained by the availability of newer broad-spectrum agents, such as ceftriaxone.

Regional Distribution:

  • North America accounts for around 40% of sales, driven by hospital procurement.
  • Europe holds approximately 35%, with steady demand in public healthcare systems.
  • Asia-Pacific presents growth opportunities, particularly in developing countries where older antibiotics still constitute mainstay treatments.

What are the key drivers influencing its market?

Regulatory Environment:
Stringent regulations in the U.S. and Europe limit new approvals for older antibiotics like cephalothin. Generic manufacturing is dominant, leading to price pressure.

Antibiotic Resistance:
Growing resistance to cephalothin reduces its clinical effectiveness, leading to decreased use in favor of newer agents such as ceftaroline.

Manufacturing and Formulation:
The use of plastic containers aligns with hospital IV administration protocols, possibly impacting procurement preferences and storage logistics. The stability and compatibility of cephalothin sodium with saline solutions influence formulation decisions.

Hospital and ICU Use:
Procurement decisions are heavily influenced by hospital formularies, with cephalothin primarily used in specific infections where local resistance patterns permit.

What are the financial prospects and competitive factors?

Revenue Trends:

  • Estimated annual global sales for cephalothin formulations are below USD 150 million, with a declining trend as usage diminishes.
  • Price points for generic injectables range from USD 10 to USD 50 per dose, depending on region and supplier.

Key Players:

  • Major generic manufacturers, including Sandoz, Pfizer, and Teva, produce cephalothin sodium.
  • Limited new entrants due to low profit margins and regulatory hurdles for older antibiotics.

Pricing and Margins:

  • Price erosion continues with increased competition.
  • Profit margins have compressed to below 10% in some markets, especially where generics dominate.

Supply Chain Considerations:

  • Raw material sourcing and production capacity constraints affect availability.
  • Packaging regulations impact plastic container specifications, especially in countries with strict sterilization standards.

How might future trends influence its market trajectory?

Emerging Resistance:
Increased resistance diminishes clinical relevance, shrinking market size further.

Development of Derivatives:
Limited pipeline exists for cephalothin modifications or new formulations, reflecting low R&D investment focus.

Regulatory and Policy Shifts:
The push for antibiotic stewardship reduces hospital use of broad-spectrum older agents, favoring newer antibiotics with better resistance profiles.

Impact of Biosimilars and New Delivery Technologies:
Growth is unlikely unless new formulations or delivery mechanisms improve clinical or logistical utility.

Summary of Market and Financial Outlook

Aspect Status Outlook
Market size USD 150 million annually Declining, stable niche
Growth rate 1-3% Slight growth in Asia-Pacific
Patent status Generic-dominated No new patents expected
Pricing USD 10–USD 50/dose Price erosion ongoing
Competition High Limited innovation

Key Takeaways

  • The market for cephalothin sodium with sodium chloride in plastic containers is declining due to antibiotic resistance and competition.
  • Regulatory constraints and low innovation hinder growth prospects.
  • Revenues are primarily derived from hospital procurement, with regional variations influencing sales.
  • Margins compress, with low profitability for manufacturers.
  • Future growth relies on niche applications and regional adoption rather than global expansion.

FAQs

1. Why is the market for cephalothin sodium declining?
Its declining use results from increased bacterial resistance, emergence of newer antibiotics, and a shift toward broader-spectrum agents.

2. Which regions are still active markets for this formulation?
North America, Europe, and select parts of Asia-Pacific, where hospital procurement maintains its presence.

3. Are there any recent regulatory changes affecting cephalothin?
Increased antimicrobial stewardship policies in developed countries limit its use, with some agencies restricting new approvals for older antibiotics.

4. What are the main competition factors?
Price competitiveness among generics, supply chain reliability, and hospital formulary inclusion.

5. Is there potential for new formulations or delivery methods?
Limited; most innovation revolves around generic manufacturing efficiencies rather than new molecular entities.


References

  1. Global Market Insights. (2023). Antibiotics Market Size and Trends.
  2. U.S. Food and Drug Administration. (2022). Antibiotic approvals and regulations.
  3. World Health Organization. (2021). Antimicrobial resistance surveillance reports.
  4. IMS Health (2022). Hospital Procurement and Antibiotics Market Trends.
  5. European Medicines Agency. (2022). Regulatory updates for antibiotics.

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