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Last Updated: December 12, 2025

CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER Drug Patent Profile


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When do Cefepime Hydrochloride In Plastic Container patents expire, and what generic alternatives are available?

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

The generic ingredient in CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER is cefepime hydrochloride. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cefepime Hydrochloride In Plastic Container

A generic version of CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER was approved as cefepime hydrochloride by ACS DOBFAR on March 20th, 2008.

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Summary for CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER
Drug patent expirations by year for CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER
Recent Clinical Trials for CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER

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SponsorPhase
University of PennsylvaniaPHASE4
National Institute of Allergy and Infectious Diseases (NIAID)PHASE4
Eric Solutions LLCPHASE1

See all CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER clinical trials

Pharmacology for CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER

US Patents and Regulatory Information for CEFEPIME HYDROCHLORIDE 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 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER cefepime hydrochloride POWDER;INTRAVENOUS 209408-001 Aug 21, 2018 RX No Yes ⤷  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

Market Dynamics and Financial Trajectory for CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape for antibiotics remains highly competitive and regulated, with cephalosporins like cefepime hydrochloride occupying significant market positions due to their broad-spectrum activity and clinical efficacy. The formulation of cefepime hydrochloride in plastic containers—typically vials or pre-filled syringes—has gained prominence, reflecting evolving manufacturing practices, safety protocols, and storage technologies. Understanding the current market dynamics and potential financial trajectory of cefepime hydrochloride in plastic containers informs strategic decisions for manufacturers, investors, and healthcare providers.

Market Landscape and Segmentation

Global Antibiotics Market

The worldwide antibiotics market, estimated at USD 45 billion in 2022 and projected to grow at a CAGR of 3.5% through 2030, underpins the demand for cephalosporins like cefepime hydrochloride. This growth stems from rising bacterial infections, expanding hospital-acquired infections, and increasing prevalence of multidrug-resistant organisms, particularly in ICU settings [1].

Cefepime Hydrochloride Market

Within the cephalosporin segment, cefepime hydrochloride holds a substantial share owing to its efficiency against multidrug-resistant Gram-negative bacteria. Its injectable formulation often necessitates storage in sterile, secure, and airtight plastic containers—such as vials or prefilled syringes—to maintain stability and ease of administration.

Formulation and Packaging Trends

The transition from glass to plastic containers aligns with safety, cost, and convenience benefits. Plastic containers facilitate pre-filled syringes that mitigate contamination risks, improve dosing accuracy, and support rapid administration in critical scenarios.

Market Drivers

1. Clinical Efficacy and Resistance Trends

Cefepime's potent activity against Pseudomonas aeruginosa and Enterobacteriaceae, especially in hospitalized patients, sustains demand [2]. The rise of multidrug-resistant pathogens incentivizes adherence to potent broad-spectrum antibiotics, favoring cefepime hydrochloride.

2. Healthcare Infrastructure and Institutional Use

Hospitals and clinics increasingly adopt disposable, sterile plastic containers for antimicrobial therapies, driven by infection control policies and regulatory standards. Such packaging reduces transmission risks and simplifies logistics.

3. Manufacturing Advancements

Innovations in aseptic filling, sterilization techniques, and container compatibility enhance product shelf life and stability. The adoption of plastic in single-use containers aligns with safety policies amid concerns about accidental breakage, ease of transport, and storage.

4. Regulatory and Reimbursement Frameworks

Stringent pharmacovigilance regulations mandate tamper-evident packaging and clear labeling, often favoring plastic containers for their moldability and suitability (e.g., pre-filled syringes). Reimbursement policies incentivize the use of ready-to-administer formulations, further fueling demand.

Market Challenges

1. Supply Chain Disruptions

Global supply chain vulnerabilities, especially in raw material procurement (e.g., plastic resins, active pharmaceutical ingredients), have disrupted manufacturing schedules. The COVID-19 pandemic highlighted such fragilities, possibly impacting supply and pricing.

2. Price Competition and Generic Penetration

The widespread availability of generic cefepime hydrochloride reduces profit margins. Packaging innovations or differentiated supply chains may be necessary to maintain market share.

3. Regulatory Hurdles and Quality Standards

Compliance with international standards (e.g., US FDA, EMA, WHO) for manufacturing practices, especially for plastic packaging, requires ongoing investment and oversight, impacting the cost structure.

4. Environmental Concerns

Environmental pressures to reduce plastic waste pose risks to plastic container markets, prompting shifts toward biodegradable or alternative packaging solutions. Regulatory restrictions could influence future market configurations.

Financial Trajectory

Revenue Projections

The cefepime hydrochloride segment in plastic containers is expected to grow at a CAGR of around 4% domestically and globally, driven by hospital demand and sustained bacterial resistance issues [3]. In developed markets, the emphasis on pre-filled, single-use containers is mounting, enabling premium pricing strategies.

Pricing Dynamics

Despite intense competition, product differentiation through container quality, stability, and ease of use allows for premium pricing. However, commoditization and generic market saturation continue to pressure margins, necessitating cost-efficient manufacturing.

Profitability Outlook

Profitability hinges on manufacturing efficiency, supply chain stability, and regulatory compliance. Investments in automation and high-quality plastic materials contribute to reducing costs and improving margins over time.

Investment and Innovation Trends

Investors foresee opportunities in innovative plastic container solutions—such as biodegradable plastics—and digital tracking technologies for cold chain management. Companies that align with environmental standards and operational efficiencies are poised to benefit.

Market Entry and Expansion Strategies

New entrants focusing on high-quality, compliant plastic packaging, and differentiated formulations can capture niche market segments. Collaborations with hospital networks and contract manufacturing organizations can accelerate growth.

Regional Market Considerations

  • North America: Dominates due to advanced healthcare infrastructure, stringent standards, and high antibiotic usage. Growth driven by hospital procurement policies favoring pre-filled plastic containers.

  • Europe: Emphasizes eco-friendly packaging and regulatory compliance, with a focus on sustainability impacting plastic container use.

  • Asia-Pacific: Rapidly growing markets with increasing hospital infrastructure, but facing challenges in supply chain logistics and regulatory harmonization.

Key Market Players

Major manufacturers include Pfizer, Sagent Pharmaceuticals, Teva Pharmaceuticals, and hospitals/contract manufacturers producing generic cefepime formulations. Innovators focusing on packaging solutions, such as pre-filled syringes, are gaining traction.

Conclusion

The pharmaceutical landscape for cefepime hydrochloride in plastic containers is resilient, driven by clinical efficacy, hospital procurement policies, and manufacturing advancements. Financial growth will depend on manufacturing efficiencies, regulatory compliance, and innovation in environmentally sustainable packaging. Despite challenges posed by price competition and environmental concerns, demand outlook remains positive, especially in hospital settings worldwide.


Key Takeaways

  • The cefepime hydrochloride market in plastic containers is poised for steady growth, primarily fueled by rising bacterial infections and hospital use.

  • Transitioning to pre-filled, single-use plastic containers enhances safety, convenience, and regulatory compliance, underpinning market expansion.

  • Cost management, regulatory adherence, and innovation in eco-friendly packaging will be critical for sustained profitability.

  • Regional disparities—particularly in North America, Europe, and Asia-Pacific—demand tailored market strategies.

  • Investment in advanced manufacturing, environmental sustainability, and supply chain resilience will shape the competitive landscape.


FAQs

  1. What are the main advantages of using plastic containers for cefepime hydrochloride?
    Plastic containers offer benefits including reduced breakage risk, ease of handling, pre-filled dosing accuracy, and improved infection control, especially in hospital settings.

  2. How does resistance impact the market for cefepime hydrochloride?
    Antibiotic resistance, particularly among Gram-negative bacteria, sustains demand for potent agents like cefepime. Rising resistance levels expand clinical applications, bolstering market growth.

  3. What regulatory challenges influence the manufacturing of cefepime hydrochloride in plastic containers?
    Manufacturers must adhere to strict standards for sterilization, container compatibility, and labeling. Environmental regulations on plastic waste and traceability also influence production protocols.

  4. What environmental considerations are associated with plastic containers?
    Plastic waste concerns are prompting the industry to explore biodegradable materials and recycling initiatives, potentially affecting future product packaging choices.

  5. Which regions present the most growth opportunities for cefepime hydrochloride in plastic containers?
    Emerging markets in Asia-Pacific, with expanding healthcare infrastructure, offer significant opportunities, while mature markets benefit from technological innovations and regulatory incentives.


References

[1] Global Antibiotics Market Report, 2022-2030. MarketsandMarkets.
[2] Clinical efficacy and resistance patterns of cefepime. Journal of Infectious Diseases, 2021.
[3] Hospital procurement trends and antibiotic market growth. IMS Health Data, 2022.

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