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Last Updated: March 27, 2026

CEFUROXIME SODIUM IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Cefuroxime Sodium In Plastic Container, and when can generic versions of Cefuroxime Sodium In Plastic Container launch?

Cefuroxime Sodium In Plastic Container is a drug marketed by Samson Medcl and is included in one NDA.

The generic ingredient in CEFUROXIME SODIUM IN PLASTIC CONTAINER is cefuroxime sodium. There are sixty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cefuroxime Sodium In Plastic Container

A generic version of CEFUROXIME SODIUM IN PLASTIC CONTAINER was approved as cefuroxime sodium by ACS DOBFAR SPA on May 30th, 1997.

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  • What is the 5 year forecast for CEFUROXIME SODIUM IN PLASTIC CONTAINER?
  • What are the global sales for CEFUROXIME SODIUM IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for CEFUROXIME SODIUM IN PLASTIC CONTAINER?
Summary for CEFUROXIME SODIUM IN PLASTIC CONTAINER
Drug patent expirations by year for CEFUROXIME SODIUM IN PLASTIC CONTAINER
Recent Clinical Trials for CEFUROXIME SODIUM IN PLASTIC CONTAINER

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

SponsorPhase
The George InstitutePHASE3
Turku University HospitalPHASE3
Helsinki University Central HospitalPHASE3

See all CEFUROXIME SODIUM IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for CEFUROXIME SODIUM 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
Samson Medcl CEFUROXIME SODIUM IN PLASTIC CONTAINER cefuroxime sodium INJECTABLE;INJECTION 065251-001 Dec 30, 2009 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Samson Medcl CEFUROXIME SODIUM IN PLASTIC CONTAINER cefuroxime sodium INJECTABLE;INJECTION 065251-002 Dec 30, 2009 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 Cefuroxime Sodium in Plastic Container

Last updated: March 17, 2026

What is the current market size and growth trend for Cefuroxime Sodium in plastic containers?

Cefuroxime sodium is a second-generation cephalosporin antibiotic used predominantly to treat bacterial infections. The global cefuroxime market was valued at approximately USD 2.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.5% from 2023 to 2030 [1].

The antibiotics segment accounts for the largest share within the antimicrobial market, driven by increasing bacterial resistance and expanding hospital-acquired infections. Cefuroxime sodium's formulations in plastic containers, primarily vials and prefilled syringes, constitute a significant portion of this, especially in North America and Europe.

What factors influence the demand for Cefuroxime Sodium in plastic containers?

Several factors drive demand growth:

  • Rising Infection Rates: Increased prevalence of respiratory, urinary tract, and surgical site infections prompts higher antibiotic use.
  • Hospital Infrastructure Expansion: Growing hospital capacities in emerging markets increase delivery of injectable antibiotics.
  • Regulatory Approvals: Approvals for new indications or formulations expand market access.
  • Preference for Plastic Packaging: Plastic containers are favored over glass for their durability, lower weight, and easier handling.

How does the manufacturing landscape influence supply and pricing?

Major manufacturers include Zydus Cadila, Sagent Pharmaceuticals, and Hikma Pharmaceuticals, who supply cefuroxime sodium in plastic vials. Patent expiry in some regions has prompted increased competition, affecting pricing.

Generic penetration is high due to the drug's off-patent status, which has restrained prices. The average unit price of cefuroxime sodium in plastic vials ranges from USD 0.50 to USD 1.50 per vial, depending on concentration and volume [2].

Manufacturing complexities, such as ensuring stability in plastic containers and sterility, influence production costs. Advanced aseptic processing and quality control are crucial to meet regulatory standards.

What are the regulatory factors affecting the market?

Regulatory authorities like the FDA, EMA, and counterparts in emerging markets enforce rigorous standards for injectable drugs. Recent updates include:

  • FDA Guidance (2021): Emphasizes good manufacturing practices and stability testing in plastic containers.
  • EMA Initiatives: Promote simplified approval procedures for generic injectables.
  • Environmental Regulations: Impact disposal and recycling requirements for plastic packaging.

Approval delays or additional compliance costs influence the time-to-market and pricing strategies.

What is the competitive landscape and product pipeline?

The market has a mix of branded and generic cefuroxime sodium products. Key competitive factors include:

  • Pricing Strategies: Price competition among generics limits excessive markups.
  • Formulation Innovations: Development of ready-to-use prefilled syringes and combination formulations.
  • Supply Chain Reliability: Ensuring uninterrupted supply in response to rising global demand.

Pipeline developments include reformulations in biodegradable plastics to meet environmental standards and extended shelf-life formulations to reduce waste.

How will market dynamics affect the financial trajectory?

Forecasted revenue growth is driven by:

  • Emerging Markets: Projected CAGR of ~6% driven by increased healthcare infrastructure.
  • Sterility & Packaging Standards: Investment in advanced packaging processes increases production costs but enhances market access.
  • Pricing Pressure: Generic competition maintains low unit prices; however, volume growth offsets margins.
  • Regulatory Costs: Compliance expenses impact profitability, especially in highly regulated regions.

Overall, global cefuroxime sodium sales in plastic containers are expected to reach approximately USD 3 billion by 2030, reflecting sustained growth amid competitive pressures.

Key considerations for investors and R&D

  • Supply chain stability in plastic container manufacturing.
  • Regulatory compliance costs in different jurisdictions.
  • Innovation in formulations and packaging to differentiate products.
  • Market expansion opportunities, especially in Asia-Pacific and Latin America.
  • Environmental sustainability initiatives, potentially increasing raw material costs.

Key Takeaways

  • The global cefuroxime sodium market in plastic containers exceeds USD 2 billion in 2022, with steady growth.
  • Demand is driven by rising infection rates, hospital infrastructure expansion, and preference for plastic packaging.
  • Competitive pressures from generics keep prices low, but innovation and market expansion buffer margins.
  • Regulatory standards influence manufacturing costs and timeline for market entry.
  • The market is forecasted to approach USD 3 billion by 2030, with emerging markets contributing significantly.

FAQs

  1. What are the main challenges in manufacturing cefuroxime sodium in plastic containers?
    Ensuring sterility, stability, and compatibility of cefuroxime sodium with plastic materials are key manufacturing challenges.

  2. How does environmental regulation impact the market?
    Regulations on plastic waste and recycling require manufacturers to adopt sustainable packaging, potentially increasing costs.

  3. What is the typical price range for cefuroxime sodium in plastic vials?
    Prices generally range from USD 0.50 to USD 1.50 per vial, depending on volume and concentration.

  4. Which regions are expected to see the highest growth?
    Asia-Pacific and Latin America are projected to experience higher CAGR due to expanding healthcare infrastructure.

  5. Are there new formulations or delivery systems under development?
    Yes, innovations include biodegradable plastics, prefilled syringe systems, and combination therapies.


References

[1] Market Research Future. (2023). Global Antibiotics Market Report. Retrieved from https://www.marketresearchfuture.com

[2] IQVIA. (2022). Pricing Database for Injectable Antibiotics.

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