Cefotaxime sodium - Generic Drug Details

What are the generic sources for cefotaxime sodium and what is the scope of freedom to operate?

Cefotaxime sodium is the generic ingredient in seven branded drugs marketed by Fresenius Kabi Usa, Hikma, Wockhardt, B Braun, Aurobindo Pharma, Aurobindo Pharma Ltd, Cephazone Pharma, Hospira, Hospira Inc, Lupin, Sanofi Aventis Us, and Sterimax, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for cefotaxime sodium. One supplier is listed for this compound.

Summary for cefotaxime sodium

US Patents:	0
Tradenames:	7
Applicants:	12
NDAs:	17
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	8
Patent Applications:	4,312
DailyMed Link:	cefotaxime sodium at DailyMed

Recent Clinical Trials for cefotaxime sodium

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

Sponsor	Phase
Fayoum University Hospital	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4

See all cefotaxime sodium clinical trials

Pharmacology for cefotaxime sodium

Drug Class

Cephalosporin Antibacterial

Medical Subject Heading (MeSH) Categories for cefotaxime sodium

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for cefotaxime sodium

J01DD	Third-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for cefotaxime sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	CEFOTAXIME SODIUM	cefotaxime sodium	INJECTABLE;INJECTION	065517-001	Nov 6, 2009		DISCN	No	No
Aurobindo Pharma	CEFOTAXIME SODIUM	cefotaxime sodium	INJECTABLE;INJECTION	065517-003	Nov 6, 2009		DISCN	No	No
Fresenius Kabi Usa	CEFOTAXIME	cefotaxime sodium	INJECTABLE;INJECTION	064201-002	Mar 24, 2000		DISCN	No	No
Hospira Inc	CEFOTAXIME SODIUM	cefotaxime sodium	INJECTABLE;INJECTION	065293-001	Aug 10, 2006		DISCN	No	No
Aurobindo Pharma	CEFOTAXIME SODIUM	cefotaxime sodium	INJECTABLE;INJECTION	065517-002	Nov 6, 2009		DISCN	No	No
Lupin	CEFOTAXIME SODIUM	cefotaxime sodium	INJECTABLE;INJECTION	065124-002	Sep 24, 2003		DISCN	No	No

Cefotaxime sodium Market Analysis and Financial Projection Experimental

Cefotaxime Sodium: Market Dynamics and Financial Trajectory

Introduction

Cefotaxime sodium, a third-generation cephalosporin antibiotic, has emerged as a crucial component in the fight against bacterial infections. Its broad-spectrum antibacterial activity and effectiveness against antibiotic-resistant strains make it a vital tool in modern medicine. Here, we delve into the market dynamics and financial trajectory of cefotaxime sodium.

Market Size and Growth Projections

The global antibiotic market, of which cefotaxime sodium is a significant part, is projected to reach approximately $45 billion by 2027. This growth is driven by the increasing demand for effective treatments against bacterial infections, particularly in the face of rising antibiotic resistance[1].

The cefotaxime sodium API market itself is expected to grow at a CAGR of 3 to 5 percent from 2024 to 2031, with its valuation estimated to increase significantly during this period. The market is segmented by application, product type, and geographical regions, with single injections and products adhering to the Chinese Pharmacopoeia (ChP) dominating the market[4].

Key Drivers of Market Growth

Several factors are driving the growth of the cefotaxime sodium market:

Increasing Antibiotic Resistance

The global challenge of antibiotic resistance has made cefotaxime sodium a critical tool. According to the World Health Organization, antimicrobial resistance leads to 700,000 deaths annually, with projections suggesting this could rise to 10 million by 2050 if not addressed. Cefotaxime's effectiveness against resistant strains positions it as a vital component in this fight[1].

Innovations in Formulation

Recent developments in formulation techniques have enhanced the stability and efficacy of cefotaxime sodium. Innovations such as extended-release formulations are under research, aiming to prolong the drug's action and improve patient compliance and treatment outcomes[1].

Strategic Partnerships and Distribution

Pharmaceutical companies are entering strategic partnerships to enhance their portfolios and streamline the distribution of cefotaxime sodium. These collaborations between manufacturers and healthcare providers ensure timely availability in hospitals and clinics, leading to improved market penetration and increased sales[1].

Mergers and Acquisitions

The competitive landscape is witnessing mergers and acquisitions as companies seek to consolidate their market position. Acquiring companies that specialize in antibiotic development can significantly boost a firm’s capabilities, positioning them favorably in the cefotaxime market[1].

Market Segmentation

The cefotaxime sodium API market is segmented in several ways:

By Application

• Single injections dominate the market, accounting for about 76.02% of the applications in 2019. Compound injections also form a significant segment[4].

By Product Type

• Products adhering to the Chinese Pharmacopoeia (ChP) account for about 77.92% of the market, followed by those adhering to the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP)[4].

By Geography

• The market is spread across North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Asia-Pacific is a significant region due to its large population and increasing healthcare needs[4].

Financial Trajectory

The financial trajectory of cefotaxime sodium is promising due to several factors:

Stable Demand

The increasing prevalence of infectious diseases and a growing geriatric population ensure sustained demand for cefotaxime sodium. This stable demand makes it an attractive investment opportunity[1].

Government Initiatives

Governments are emphasizing healthcare reforms and antibiotic stewardship programs, which are expected to expedite approvals for antibiotics like cefotaxime. This could lead to faster market entry for new formulations, enhancing investment potential[1].

Regulatory Framework

Although the pharmaceutical sector is characterized by rigorous regulatory frameworks, the ongoing focus on improving antibiotic availability may introduce favorable regulations. This could expedite the approval process for new formulations of cefotaxime, further boosting its market potential[1].

Challenges in the Antibiotic Market

Despite the promising outlook, the antibiotic market, including cefotaxime sodium, faces several challenges:

Economic Incentives

The market for antibiotics is often characterized by low economic incentives. Antibiotics are cheaper and taken for shorter periods compared to other medicines, making them less lucrative for pharmaceutical companies. High registration costs, limited volume sales, and low prices are significant deterrents[3].

Scientific and Regulatory Hurdles

Developing new antibiotics involves significant scientific and regulatory hurdles. The risk-adjusted net present value (rNPV) for antibiotic R&D projects is typically lower than for other therapeutic categories, which can discourage investment in this area[3].

Investor Interest

Investors are keenly eyeing the cefotaxime market due to its stable demand and critical role in healthcare. The market's growth potential, coupled with the increasing importance of effective antibiotics, makes cefotaxime sodium an attractive investment opportunity.

Key Takeaways

• Market Growth: The cefotaxime sodium market is expected to grow at a CAGR of 3 to 5 percent from 2024 to 2031.
• Drivers: Increasing antibiotic resistance, innovations in formulation, strategic partnerships, and mergers and acquisitions drive market growth.
• Segmentation: The market is segmented by application, product type, and geography.
• Financial Trajectory: Stable demand, government initiatives, and favorable regulatory frameworks contribute to a promising financial trajectory.
• Challenges: Economic incentives, scientific, and regulatory hurdles pose challenges to the antibiotic market.

FAQs

Q: What is cefotaxime sodium used for? A: Cefotaxime sodium is used to treat severe bacterial infections, including pneumonia, urinary tract infections, and septicemia. It is effective against a broad spectrum of Gram-positive and Gram-negative bacteria[1][5].

Q: How does cefotaxime sodium work? A: Cefotaxime sodium works by inhibiting bacterial cell wall synthesis, leading to cell lysis and death. This mechanism makes it particularly effective against bacteria resistant to other antibiotics[1][5].

Q: What are the recent trends in the cefotaxime sodium market? A: Recent trends include innovations in formulation, strategic partnerships for distribution, and mergers and acquisitions among pharmaceutical companies[1].

Q: What are the challenges faced by the antibiotic market, including cefotaxime sodium? A: The antibiotic market faces challenges such as low economic incentives, high registration costs, limited volume sales, and significant scientific and regulatory hurdles[3].

Q: Why is cefotaxime sodium an attractive investment opportunity? A: Cefotaxime sodium is an attractive investment due to its stable demand, critical role in healthcare, and the potential for favorable regulatory frameworks to expedite market entry for new formulations[1].

Sources

1. Market Research Intellect - Cefotaxime Sodium Injection: The Unsung Hero of Antibiotic Treatment in Pharma[1]
2. Frontiers in Microbiology - A Mechanism of Synergistic Effect of Streptomycin and Cefotaxime[2]
3. Access to Medicine Foundation - Antimicrobial Resistance Benchmark 2018[3]
4. Market Research Intellect - Global Cefotaxime Sodium API Market Size and Forecast[4]
5. NCBI Bookshelf - Cefotaxime - StatPearls[5]