Last Updated: May 2, 2026

ZINACEF IN PLASTIC CONTAINER Drug Patent Profile


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When do Zinacef In Plastic Container patents expire, and when can generic versions of Zinacef In Plastic Container launch?

Zinacef In Plastic Container is a drug marketed by Pai Holdings Pharm and is included in one NDA.

The generic ingredient in ZINACEF 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 Zinacef In Plastic Container

A generic version of ZINACEF 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 ZINACEF IN PLASTIC CONTAINER?
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Summary for ZINACEF IN PLASTIC CONTAINER
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for ZINACEF 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
Pai Holdings Pharm ZINACEF IN PLASTIC CONTAINER cefuroxime sodium INJECTABLE;INJECTION 050643-001 Apr 28, 1989 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pai Holdings Pharm ZINACEF IN PLASTIC CONTAINER cefuroxime sodium INJECTABLE;INJECTION 050643-002 Apr 28, 1989 DISCN Yes 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

ZINACEF IN PLASTIC CONTAINER Market Analysis and Financial Projection

Last updated: February 15, 2026

Investment Scenario and Fundamentals Analysis for ZINACEF in Plastic Container

Market Overview

ZINACEF (Cefazolin), an injectable antibiotic, has established a presence in both hospital and outpatient settings. It treats bacterial infections caused by susceptible organisms. The formulation in a plastic container has gained prominence due to ease of use, safety, and sterility.

Production and Distribution Profile

  • Formulation: Intravenous (IV) cefazolin in plastic vials or pre-filled syringes.
  • Manufacturers: Leading pharmaceutical firms such as Pfizer, Sandoz, and Teva produce ZINACEF.
  • Distribution: Primarily through hospital procurement, wholesale distributors, and regional health authorities. Growing outpatient use in some regions.

Market Dynamics

  • Global Market Value (2022): Estimated at approximately $400 million for cefazolin. Projected CAGR (2022-2027): 3.5–4%.
  • Segments: Hospital use constitutes roughly 75%. Outpatient and home injection segments grow at 5% annually.
  • Regional Trends:
    • North America: Dominates with 45% market share.
    • Europe: Second-largest, driven by antimicrobial stewardship.
    • Asia-Pacific: Rapid growth, CAGR exceeding 6%, due to expanding healthcare infrastructure.

Key Drivers

  • Antimicrobial Stewardship: Preference for first-line β-lactam antibiotics reduces resistance concerns.
  • Sterility and Convenience: Plastic containers support ease of handling, reduced contamination risk.
  • Regulatory Approvals: Ongoing approvals for new indications and formulations expand market reach.
  • R&D Pipeline: Several companies investing in biosimilar and combination products.

Competitive Landscape

Company Market share Product Portfolio Focus Areas
Pfizer 50% ZINACEF, other cefazolin formulations Hospital generics
Sandoz 25% Biosimilars, generics Cost-effective alternatives
Teva 15% Generic antibiotics, biosimilars Domestic and emerging markets
Others 10% Various local and regional players Niche markets

Investment Considerations

  • Market Maturity: The cefazolin market exhibits stability with moderate growth, primarily driven by hospital procurement cycles.
  • Patent Status: ZINACEF formulations are off-patent, leading to price competition and margin pressures.
  • Regulatory Environment: Stringent approval processes can delay new indications; however, current formulations face minimal regulatory hurdles.
  • Pricing Trends: Competitive pricing reduces profitability margins, especially for generics.

Financial Fundamentals

  • Revenue Analysis: A mature product with steady revenues; potential for growth in emerging markets.
  • Cost Structure:
    • Manufacturing costs:< $0.50 per dose in high-volume settings.
    • R&D costs: Minimal for formulation in existing patents.
    • Regulatory and marketing expenses: Moderate.
  • Profit Margins: Gross margins around 35–45%, subject to pricing pressures.

Risks and Opportunities

Risks:

  • Competition from biosimilars or alternative antibiotics.
  • Regulatory delays or restrictions.
  • Antibiotic resistance diminishing use.

Opportunities:

  • Expansion into outpatient and home-care markets.
  • Development of fixed-dose combinations.
  • Entry into emerging markets with lower penetration.

Regulatory and Compliance Factors

  • FDA and EMA approval standards influence manufacturing practices.
  • WHO Prequalification enhances export potential.
  • Quality Assurance: Good Manufacturing Practices (GMP) compliance essential for global acceptance.

Key Takeaways

  • ZINACEF in a plastic container is a stable, low-growth asset suitable for companies with established manufacturing and distribution channels.
  • Market growth hinges on expanding outpatient use, biosimilars competition, and geographic diversification.
  • Margins are under pressure from generic pricing, but volume and geographic expansion offer potential.
  • Regulatory stability simplifies market maintenance; innovation opportunities are limited without new formulations or indications.
  • Emerging markets provide growth potential, but require investment in logistics and compliance.

FAQs

Q1: How does the market for ZINACEF compare to other injectable antibiotics?
A1: ZINACEF's market size is moderate; it faces competition from other β-lactams like ceftriaxone but benefits from its established safety profile and ease of formulation in plastic containers.

Q2: What are the main barriers to market expansion for ZINACEF?
A2: Patent expirations, price competition, resistance development, and regulatory hurdles limit growth. Expanding into outpatient settings and emerging markets offers the best prospects.

Q3: How does antimicrobial resistance affect ZINACEF's market?
A3: Rising resistance reduces the drug’s efficacy, leading to decreased use. Stewardship programs also limit unnecessary prescriptions, constraining sales.

Q4: Are there any recent innovations or pipeline developments related to ZINACEF?
A4: Currently, no significant new formulations or indications are in late-stage development, focusing instead on biosimilars and fixed-dose combinations to sustain market presence.

Q5: What strategies could a company pursue to maximize returns from ZINACEF?
A5: Focus on cost-effective manufacturing, expanding into underpenetrated markets, developing combination therapies, and reinforcing supply chain resilience.


Sources:

[1] Market Research Future (2022). Global Cefazolin Market.
[2] IQVIA (2022). Antimicrobial Market Data.
[3] FDA (2023). Approved Cefazolin Products List.
[4] WHO (2021). Antimicrobial Resistance Strategic Framework.
[5] Company Annual Reports (2022). Pfizer, Sandoz, Teva.

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