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Last Updated: December 22, 2024

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. Ten 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

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

SponsorPhase
Biomedical Advanced Research and Development AuthorityPhase 3
Meiji Seika Pharma Co., Ltd.Phase 3
AllecraPhase 2

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cefepime Hydrochloride in Plastic Containers

Market Overview

The market for cefepime hydrochloride, particularly in plastic containers, is experiencing significant growth driven by several key factors. Here’s a detailed look at the market dynamics and financial trajectory of this antibiotic.

Growth Drivers

Increasing Demand for Antibiotics

The global demand for antibiotics, including cefepime hydrochloride, is on the rise due to the growing incidence of bacterial infections and the need for effective treatments. This demand is particularly high in hospitals and retail pharmacies, which are the primary application segments for cefepime hydrochloride[1][4].

Expanding Geographical Reach

The market for cefepime hydrochloride is not limited to a single region; it spans across North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. This broad geographical reach contributes to the overall growth of the market[1][4].

Product Variations and Applications

Cefepime hydrochloride is available in various strengths (0.5g/Piece, 1.0g/Piece, 2.0g/Piece), which caters to different clinical needs. Its application in treating a range of bacterial infections, including complicated urinary tract infections and hospital-acquired bacterial pneumonia, further boosts its market potential[1][4].

Market Size and Projections

Current Market Size

The global cefepime hydrochloride market has seen substantial growth in recent years. For instance, in the first quarter of 1996, Elan reported a 25% increase in sales of Maxipime (cefepime HCl) to $44.7 million, indicating strong market performance[2].

Future Projections

Forecasts suggest that the cefepime hydrochloride market will continue to expand significantly from 2023 to 2031. The market is expected to exhibit robust growth rates, driven by sustained expansion in market dynamics and favorable trends in the healthcare sector[1][4].

Financial Performance

Revenue Growth

The financial performance of the cefepime hydrochloride market is marked by steady revenue growth. The market size is estimated to increase substantially over the forecast period, with revenue projections indicating a compound annual growth rate (CAGR) that underscores the market's optimistic outlook[1][4].

Sales and Profitability

Companies involved in the production and distribution of cefepime hydrochloride have reported positive financial results. For example, Elan's first-quarter sales rose 31% to $134 million, with significant contributions from antibiotic sales, including Maxipime[2].

Key Players and Collaborations

Market Participants

The market for cefepime hydrochloride involves several key players, including pharmaceutical companies like Elan, Melinta, and Venatorx. These companies are actively involved in the development, production, and commercialization of cefepime hydrochloride and its combinations, such as cefepime-taniborbactam[2][5].

Strategic Partnerships

Strategic partnerships and collaborations are crucial in driving the market forward. For instance, Venatorx and Melinta have entered into an exclusive license agreement to commercialize cefepime-taniborbactam in the U.S., which is expected to enhance market penetration and revenue[5].

Challenges and Opportunities

Regulatory Hurdles

Despite the positive outlook, the market faces regulatory challenges. For example, the FDA requested additional chemistry, manufacturing, and controls (CMC) data for cefepime-taniborbactam, which has delayed its approval. However, companies are working closely with regulatory bodies to address these issues[5].

Market Opportunities

The increasing prevalence of multidrug-resistant bacterial infections presents a significant opportunity for cefepime hydrochloride and its combinations. The development of new formulations, such as cefepime-taniborbactam, is expected to capture a larger market share and address unmet clinical needs[5].

Stability and Formulation

Stability Studies

Research on the stability of cefepime hydrochloride in various drug combinations is critical for its effective use. Studies have shown that the stability of cefepime hydrochloride varies with temperature and the presence of other drugs. For instance, mixtures with calcium ions show greater stability, while exposure to UV radiation significantly reduces stability[3].

Formulation in Plastic Containers

The use of plastic containers for cefepime hydrochloride is a common practice due to its convenience and safety. However, the stability of the drug in these containers must be carefully monitored to ensure its efficacy and safety over time[3].

Regional Analysis

Global Market Segmentation

The market for cefepime hydrochloride is segmented into several geographical regions, each with its own market dynamics. North America, Europe, and Asia-Pacific are among the key regions driving the market growth[1][4].

Country-Level Analysis

Country-level analysis reveals varying market trends and growth rates. For example, the Asia-Pacific region is expected to show significant growth due to increasing healthcare expenditure and a large patient population[4].

Consumer Behavior and Economic Factors

Consumer Demand

Consumer demand for effective antibiotic treatments is a key driver of the market. The increasing awareness of bacterial infections and the need for prompt treatment contribute to the growing demand for cefepime hydrochloride[1].

Economic Factors

Economic factors such as national GDP, healthcare policies, and reimbursement scenarios also influence the market. The economic stability of a region can impact the affordability and accessibility of cefepime hydrochloride, thereby affecting market growth[1][4].

Conclusion

The market for cefepime hydrochloride in plastic containers is poised for significant growth, driven by increasing demand, expanding geographical reach, and the development of new formulations. Despite regulatory challenges, the market is expected to exhibit robust growth rates over the forecast period.

Key Takeaways

  • Growing Demand: Increasing incidence of bacterial infections drives demand.
  • Geographical Expansion: Market spans across multiple regions globally.
  • Product Variations: Available in various strengths and applications.
  • Financial Performance: Steady revenue growth and positive financial results.
  • Regulatory Challenges: Addressing CMC data requests for new formulations.
  • Stability and Formulation: Careful monitoring of stability in plastic containers.
  • Regional Analysis: Significant growth expected in Asia-Pacific and other regions.

FAQs

What are the primary application segments for cefepime hydrochloride?

The primary application segments for cefepime hydrochloride are hospital pharmacies and retail pharmacies[1].

How does the stability of cefepime hydrochloride vary with different conditions?

The stability of cefepime hydrochloride varies significantly with temperature and the presence of other drugs. Mixtures with calcium ions show greater stability, while exposure to UV radiation reduces stability[3].

What are the key regions driving the growth of the cefepime hydrochloride market?

The key regions driving the growth of the cefepime hydrochloride market include North America, Europe, and Asia-Pacific[1][4].

What are the regulatory challenges faced by new formulations like cefepime-taniborbactam?

New formulations like cefepime-taniborbactam face regulatory challenges, including the need for additional CMC data, which can delay approval[5].

How do economic factors influence the market for cefepime hydrochloride?

Economic factors such as national GDP, healthcare policies, and reimbursement scenarios influence the affordability and accessibility of cefepime hydrochloride, thereby affecting market growth[1][4].

Sources

  1. MarketResearchIntellect: Global Cefepime Hydrochloride for Injection Market Size, Trends ...
  2. PharmaTimes: Elan says losses narrow in Q1
  3. MDPI: The Stability Study of Cefepime Hydrochloride in Various Drug Combinations
  4. Cognitive Market Research: Cefepime Injection Market Report 2024 (Global Edition)
  5. Venatorx: Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam

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