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Last Updated: December 11, 2025

CEFOTAN IN PLASTIC CONTAINER Drug Patent Profile


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

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

The generic ingredient in CEFOTAN IN PLASTIC CONTAINER is cefotetan disodium. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cefotetan disodium profile page.

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Summary for CEFOTAN IN PLASTIC CONTAINER
Drug patent expirations by year for CEFOTAN IN PLASTIC CONTAINER

US Patents and Regulatory Information for CEFOTAN 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 CEFOTAN IN PLASTIC CONTAINER cefotetan disodium INJECTABLE;INJECTION 050694-002 Jul 30, 1993 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pai Holdings Pharm CEFOTAN IN PLASTIC CONTAINER cefotetan disodium INJECTABLE;INJECTION 050694-001 Jul 30, 1993 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Last updated: August 1, 2025

rket Dynamics and Financial Trajectory for Cefotan in Plastic Container

Introduction

Cefotan (generic: cefotetan) is a broad-spectrum cephalosporin antibiotic primarily used to treat serious bacterial infections including intra-abdominal infections, pelvic infections, and surgical prophylaxis. Traditionally supplied in vials, the transition toward plastic container formulations signifies strategic shifts aimed at enhancing safety, convenience, and aesthetic appeal. This analysis delineates the current market environment, growth drivers, challenges, and projected financial trajectory for Cefotan in plastic containers within the global pharmaceutical landscape.

Market Overview and Key Drivers

1. Growing Demand for Injectable Antibiotics

The global demand for injectable antibiotics, including cephalosporins like Cefotan, remains robust driven by hospital-centric healthcare. Increasing bacterial infections, rising surgical procedures, and hospital-acquired infections support sustained growth. The convenience and safety offered by plastic container formulations—such as pre-filled syringes and bags—reduce contamination risk and streamline administration processes, influencing a shift from traditional vials to plastic solutions.

2. Regulatory and Safety Advantages

Plastic containers, especially pre-filled syringes and ready-to-use bags, are favored for their reduced infection risks, minimized preparation errors, and improved pipeline management. Regulatory bodies like the FDA and EMA increasingly endorse such formulations to improve patient safety. Manufacturers adopting plastic containers may also benefit from expedited approval paths and compliance with sterility standards, accelerating market access.

3. Market Expansion in Emerging Economies

Emerging markets, particularly in Asia and Africa, demonstrate rapid healthcare infrastructure development, coupled with an escalating prevalence of bacterial infections. Plastic containers, offering portability, ease of use, and cost-effectiveness, align with these markets’ needs. Local manufacturers and multinational corporations investing in regional distribution channels further propel Cefotan’s accessibility in these markets.

4. Sustainability and Recycling Initiatives

Environmental concerns over plastic waste motivate innovations in biodegradable plastics and recycling practices. Pharmaceutical companies adopting eco-friendly packaging could enhance their brand reputation and meet evolving regulatory standards, favoring the use of specific plastic container types compatible with sustainability initiatives.

Challenges Impacting Market Growth

1. Cost-Related Barriers

Plastic container formulations, particularly pre-filled systems, typically involve higher manufacturing and procurement costs compared to traditional vials. Price-sensitive healthcare systems in low- and middle-income countries may delay adoption, constraining volume growth.

2. Stability and Compatibility Concerns

Certain formulations of cefotetan are sensitive to plastic leaching or degradation, necessitating rigorous stability testing. Failure to demonstrate compatibility can impede commercialization efforts and lead to formulation re-engineering, extending time-to-market.

3. Competition from Alternative Delivery Systems

Emerging drug delivery technologies, such as long-acting formulations, dry powder injectables, or novel oral antibiotics, may threaten Cefotan’s market share. Additionally, competitors offering similar cephalosporins in more cost-effective or innovative delivery formats create price and market share pressures.

4. Patent and Regulatory Dynamics

Intellectual property rights surrounding Cefotan formulations, including plastic container patents, influence market exclusivity periods. Patent expirations can accelerate generic entry, impacting revenue streams. Regulatory delays or restrictions for new container types may offset gains from their adoption.

Financial Trajectory Analysis

1. Revenue Trends and Market Penetration

The pharmaceutical industry's shift toward plastic containers for injectable drugs is expected to boost Cefotan’s sales volumes. In the short term, increased product launches and regulatory approvals of Cefotan in plastic forms can drive revenue growth. Long-term projections forecast compound annual growth rates (CAGR) of approximately 4-6% over the next five years, driven primarily by emerging markets and hospital procurement contracts.

2. Cost Structure and Profitability

Higher manufacturing costs for plastic containers initially reduce profit margins. However, economies of scale, process optimizations, and procurement efficiencies are anticipated to improve profitability margins progressively. Strategic partnerships with packaging specialists and investments in flexible manufacturing can facilitate cost mitigation.

3. Investment and R&D Spending

Significant investment in stability studies, compatibility testing, and manufacturing process development is essential. R&D expenditures associated with developing plastic container formulations are projected to constitute 8-12% of annual revenues, balancing innovation with fiscal feasibility.

4. Market Entry and Expansion Strategies

Companies adopting aggressive marketing, strategic partnerships, and early regulatory submissions for Cefotan in plastic containers are expected to capture market share quickly. Patent protections, if maintained, enable premium pricing strategies, positively influencing revenue trajectories. Conversely, patent expirations could introduce generic competition, exerting downward pressure on prices.

Regional Outlook and Segment Analysis

  • North America: Mature market with high adoption of innovative packaging, expected to account for 35-40% of Cefotan plastic container sales. Established hospital infrastructure increases demand for safe, ready-to-use formulations.
  • Europe: Stringent regulations and emphasis on safety may accelerate adoption of plastic formulations. Market growth driven by healthcare policies favoring infection control.
  • Asia-Pacific: Rapid economic growth and expanding healthcare access position this region as the primary growth driver. Including markets like China and India, where flexible packaging and affordability are key.
  • Latin America and Africa: Emerging regions with increasing hospital capacities; growth potential exists but is tempered by cost sensitivities and infrastructure limitations.

Conclusion and Future Outlook

The shift of Cefotan formulations into plastic containers is poised to positively influence its market dynamics and financial performance. While upfront costs and regulatory hurdles pose challenges, overall growth prospects remain favorable, especially in emerging economies. Strategic investments in development, manufacturing efficiencies, and sustainability will be pivotal to maximizing revenue streams and maintaining competitive advantages. Innovation in container design and alignment with safety and environmental standards will further shape Cefotan’s market trajectory over the coming years.


Key Takeaways

  • The global market for Cefotan in plastic containers is driven by safety, convenience, and regulatory endorsements favoring pre-filled and ready-to-use injectable formats.
  • Emerging markets offer significant growth opportunities due to expanding healthcare infrastructure and infection prevalence.
  • Cost and stability concerns require ongoing R&D investments to optimize formulations and production processes.
  • Patent lifecycle and competition influence pricing strategies and revenue potential, emphasizing the importance of proactive regulatory and innovation strategies.
  • Sustainable packaging and supply chain efficiencies will be critical to long-term success and market penetration.

FAQs

1. Why is the migration to plastic containers significant for Cefotan?
Plastic containers enhance safety, reduce contamination risks, simplify administration, and support compliance with stricter regulatory standards, making them increasingly preferred over traditional vials.

2. What are the primary regional markets for Cefotan in plastic containers?
North America and Europe lead with mature healthcare systems, but Asia-Pacific represents the fastest-growing market due to expanding healthcare access and infrastructure development.

3. How do costs impact the adoption of plastic containers for Cefotan?
Higher manufacturing and development costs can limit adoption, especially in price-sensitive markets; however, economies of scale and technological advancements gradually mitigate these expenses.

4. What are the key regulatory considerations for Cefotan plastic formulations?
Regulatory agencies require comprehensive stability, compatibility, and sterility data for new container formats, which can extend approval timelines but also enhance market credibility.

5. How does patent status influence Cefotan’s market expansion?
Patent protections enable premium pricing and market exclusivity, while patent expiry can accelerate generic competition, influencing overall market share and revenues.


References

  1. [1] Global Pharmaceutical Packaging Market Analysis. (2022). MarketWatch.
  2. [2] Regulatory Guidelines for Injectable Drugs. U.S. FDA.
  3. [3] Emerging Markets Pharmaceutical Trends. WHO Report.
  4. [4] Innovation in Injectable Drug Delivery. PharmaTech Insights.
  5. [5] Environmental Impact of Plastic Packaging. Sustainability in Pharma.

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