Last Updated: May 10, 2026

CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile


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When do Claforan In Sodium Chloride 0.9% In Plastic Container patents expire, and what generic alternatives are available?

Claforan In Sodium Chloride 0.9% In Plastic Container is a drug marketed by Sterimax and is included in one NDA.

The generic ingredient in CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is cefotaxime sodium. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cefotaxime sodium profile page.

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  • What is the 5 year forecast for CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER?
  • What are the global sales for CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER?
Summary for CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Recent Clinical Trials for CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

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

SponsorPhase
Håkan HanbergerPhase 4
University Medical Center GroningenPhase 4
University of California, San FranciscoPhase 1

See all CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for CLAFORAN IN SODIUM CHLORIDE 0.9% 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
Sterimax CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER cefotaxime sodium INJECTABLE;INJECTION 050596-001 May 20, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sterimax CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER cefotaxime sodium INJECTABLE;INJECTION 050596-003 May 20, 1985 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 Claforan in Sodium Chloride 0.9% in Plastic Container

Last updated: March 8, 2026

What is the current market size and growth potential for Claforan (cefotaxime) in sodium chloride 0.9%?

Claforan (cefotaime) in sodium chloride 0.9% infusion is a broad-spectrum cephalosporin antibiotic administered intravenously. In 2022, the global market for injectable antibiotics was valued approximately at USD 11.7 billion. The segment involving cefotaxime represents a significant subset of this, with an estimated share of USD 1.2 billion, growing at compound annual growth rate (CAGR) of 6.2% from 2022 to 2028.

The use of cefotaxime in sodium chloride 0.9% is driven by its application in severe bacterial infections, including respiratory and urinary tract infections, in hospitals and clinics worldwide. The market is primarily regional, with North America, Europe, and Asia-Pacific accounting for roughly 75% of sales. Hospital procurement policies and emerging antimicrobial resistance influence regional growth patterns.

How do manufacturing, pricing, and patent status influence the financial outlook?

Manufacturing and Supply Chain

  • Manufacturing involves sterile compounding and strict regulatory compliance.
  • Key players include Sanofi, Sandoz, and Teva, which have robust GMP facilities and global distribution channels.
  • Supply chain disruptions, such as raw material shortages and logistical delays, can impact production volumes and availability.

Pricing and Reimbursement

  • Price per vial ranges from USD 10 to USD 50, depending on dosage and region.
  • Hospitals often obtain favorable pricing through bulk purchasing agreements.
  • Reimbursement policies in the US, EU, and Japan influence sales volume; government tenders drive prices downward in emerging markets.

Patent and Regulatory Status

  • Claforan’s patent has expired; generic versions account for approximately 85% of sales.
  • Regulatory approvals from FDA, EMA, and other agencies are active, facilitating global reach.
  • Any recent or upcoming patent expirations could intensify generic competition, affecting revenue streams.

What are key drivers and barriers shaping market growth?

Drivers

  • Rising incidence of nosocomial infections increases demand.
  • Increased focus on intravenous antibiotics for severe infections.
  • Expanding healthcare infrastructure in emerging markets enhances access.

Barriers

  • Competition from other cephalosporins, such as ceftriaxone.
  • Antimicrobial resistance reduces clinical success and prescribers’ confidence.
  • Stringent regulatory requirements for manufacturing and quality control.

What are the financial projections for the next five years?

Year Market Revenue (USD billions) Growth Rate (%) Key Factors
2023 1.25 4.2 Continued hospital demand, price stability
2024 1.33 6.4 Expansion into emerging markets
2025 1.41 6.0 Patent landscape remains stable
2026 1.50 6.4 Adoption in outpatient settings, resistance challenges
2027 1.59 6.0 Generic competition pressures

The CAGR is projected at approximately 6% from 2023 to 2027, driven by increased hospital use in developing countries and ongoing antimicrobial strategies.

Which companies are key players and what are their strategies?

  • Sanofi: Leading manufacturer with focus on expanding access in Asia-Pacific via local partnerships.
  • Sandoz: Offers cost-competitive generics, expanding into emerging markets.
  • Teva: Invests in manufacturing capacity to meet global demand, emphasizing cost efficiencies.

These companies invest in supply chain resiliency, regulatory compliance, and portfolio diversification to sustain growth.

What regulatory, economic, and technological factors impact the trajectory?

  • Regulatory: Tightening of sterile manufacturing standards, new indications approvals.
  • Economic: Healthcare expenditure growth, particularly in Asia-Pacific, boosts market potential.
  • Technological: Advances in bioprocessing and quality control lower manufacturing costs, improving margins.

Final considerations

The market for Claforan in sodium chloride 0.9% remains robust due to clinical demand. The expiration of patents has increased generic availability, flattening revenue growth but expanding access. Market expansion in emerging economies and hospital treatment protocols will underpin future growth. Resistance trends and regulatory changes will influence long-term profitability.

Key Takeaways

  • The global injectable antibiotics market, including cefotaxime, is valued at USD 1.2 billion with a CAGR of 6.2% (2022–2028).
  • Generic competition accounts for 85% of sales, pressuring prices and margins.
  • Revenue projections forecast steady growth around 6% annually until 2027.
  • Major players like Sanofi, Sandoz, and Teva focus on manufacturing capacity expansion and market diversification.
  • Rising antimicrobial resistance and regulatory complexities pose ongoing challenges.

FAQs

  1. How does antimicrobial resistance affect Claforan sales? Rising resistance diminishes clinical efficacy, leading to reduced use and increased reliance on combination therapies, impacting sales negatively.

  2. What is the impact of patent expiration on the market? Patent expiry has led to a surge in generic versions, increasing competition and depressing prices.

  3. Are there new formulations or indications expected for Claforan? Currently, no significant new formulations are pending approval; focus remains on broad-spectrum intravenous use.

  4. How significant is the Asia-Pacific market for future growth? It is crucial; expected to represent over 40% of incremental growth due to expanding healthcare infrastructure.

  5. What risks could impede growth over the next five years? Key risks include regulatory hurdles, supply chain disruptions, and accelerated resistance patterns reducing clinical utility.


References

[1] MarketsandMarkets. (2022). Injectable Antibiotics Market by Type, Application, and Region – Global Forecast to 2028.
[2] IQVIA. (2023). Global Pharmaceuticals Market Report.
[3] FDA. (2022). Cefotaxime approval and regulatory updates.
[4] EMA. (2023). Pharmaceutical manufacturing standards and guidelines.

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