Cefotetan disodium - Generic Drug Details

What are the generic sources for cefotetan disodium and what is the scope of freedom to operate?

Cefotetan disodium is the generic ingredient in four branded drugs marketed by Pai Holdings Pharm, Teligent, Fresenius Kabi Usa, Hikma, West-ward Pharm Corp, and B Braun, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for cefotetan disodium. Three suppliers are listed for this compound.

Summary for cefotetan disodium

US Patents:	0
Tradenames:	4
Applicants:	6
NDAs:	8
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	1
Patent Applications:	1,449
Drug Prices:	Drug price trends for cefotetan disodium
What excipients (inactive ingredients) are in cefotetan disodium?	cefotetan disodium excipients list
DailyMed Link:	cefotetan disodium at DailyMed

See drug prices for cefotetan disodium

Recent Clinical Trials for cefotetan disodium

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

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

See all cefotetan disodium clinical trials

Pharmacology for cefotetan disodium

Drug Class

Cephalosporin Antibacterial

Medical Subject Heading (MeSH) Categories for cefotetan disodium

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for cefotetan disodium

J01DC	Second-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for cefotetan disodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	cefotetan disodium	INJECTABLE;INJECTION	065430-002	Aug 9, 2007		DISCN	Yes	No
B Braun	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	cefotetan disodium	INJECTABLE;INJECTION	065430-001	Aug 9, 2007		DISCN	Yes	No
Teligent	CEFOTAN	cefotetan disodium	INJECTABLE;INJECTION	063293-001	Apr 29, 1993		DISCN	No	No
West-ward Pharm Corp	CEFOTETAN	cefotetan disodium	INJECTABLE;INJECTION	091030-001	Oct 26, 2011		DISCN	No	No
Teligent	CEFOTAN	cefotetan disodium	INJECTABLE;INJECTION	063293-002	Apr 29, 1993		DISCN	No	No
Pai Holdings Pharm	CEFOTAN	cefotetan disodium	INJECTABLE;INJECTION	050588-001	Dec 27, 1985	AP	RX	Yes	No
Pai Holdings Pharm	CEFOTAN IN PLASTIC CONTAINER	cefotetan disodium	INJECTABLE;INJECTION	050694-001	Jul 30, 1993		DISCN	No	No

Cefotetan disodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cefotetan Disodium

Introduction

Cefotetan disodium, a second-generation cephalosporin antibiotic, is widely used for its broad-spectrum antimicrobial activity, particularly against gram-negative bacteria, some anaerobic bacteria, and streptococci. Here, we delve into the market dynamics and financial trajectory of this crucial pharmaceutical product.

Market Size and Growth

The global market for cefotetan disodium API is projected to grow significantly over the next few years. As of 2023, the market was estimated to be worth several million USD, and it is forecasted to reach a readjusted size by 2030, driven by a Compound Annual Growth Rate (CAGR) of around 5%[1].

Key Players

The market is dominated by several key players, including ACS Dobfar, Zhejiang East Asia Pharmaceutical, Jeil Pharmaceutical, Xi'an Ruixi Biological Technology, and Beijing Mega Pharmaceutical Science and Technology. These companies play a crucial role in the production, distribution, and innovation within the cefotetan disodium API market[1].

Segmentation by Type and Application

The cefotetan disodium API market is segmented based on type and application. The types include purity levels such as ≥98% and <98%, while the applications primarily involve injections and other medical uses. Understanding these segments is vital for targeting specific market needs and optimizing production strategies[1].

Regional Market

The market is analyzed by region, with different regions exhibiting varying demand and growth patterns. The global pharmaceutical market, which includes cefotetan disodium, was valued at approximately $1.475 trillion in 2022 and is expected to continue growing at a CAGR of 5% over the next six years[1].

Pharmacokinetics and Tolerability

The pharmacokinetic profile of cefotetan disodium is a critical factor in its market success. Studies have shown that cefotetan disodium exhibits favorable pharmacokinetics, including high stability against beta-lactamases and strong antimicrobial activity. It has a plasma half-life of approximately 4 hours in patients with normal renal function, which can be prolonged in those with renal impairment[2][3].

Clinical Use and Safety

Cefotetan disodium is used for the treatment and prophylaxis of infections caused by susceptible bacteria. It is administered intravenously or intramuscularly and is known for its efficacy in treating a range of infections. However, it also comes with potential side effects, such as hemolytic anemia and Clostridium difficile-associated diarrhea, which must be monitored and managed appropriately[2].

Market Drivers

Several factors drive the growth of the cefotetan disodium API market:

• Increasing Demand for Antibiotics: The rising incidence of bacterial infections and the need for effective antibiotics drive the demand for cefotetan disodium.
• Advancements in Pharmaceutical Technology: Continuous improvements in manufacturing processes and the development of new formulations contribute to market growth.
• Expanding Healthcare Infrastructure: Growing healthcare infrastructure in emerging markets increases the accessibility and demand for antibiotics like cefotetan disodium[1].

Market Challenges

Despite the growth potential, the market faces several challenges:

• Antibiotic Resistance: The increasing resistance to antibiotics poses a significant threat to the long-term viability of cefotetan disodium.
• Regulatory Hurdles: Strict regulatory requirements and the need for ongoing pharmacokinetic studies can slow market expansion.
• Competition from Alternative Treatments: The emergence of new antibiotics and alternative treatments can compete with cefotetan disodium for market share[1][3].

Financial Performance

The financial performance of the cefotetan disodium API market is closely tied to the overall pharmaceutical industry. With a projected CAGR of 5%, the market is expected to see significant revenue growth. The global pharmaceutical market's size and growth rate provide a robust backdrop for the financial trajectory of cefotetan disodium[1].

Regional Economic Impact

The economic impact of cefotetan disodium varies by region. In regions with well-developed healthcare systems, the demand for high-quality antibiotics like cefotetan disodium is higher, contributing to greater economic activity. In emerging markets, the growing healthcare infrastructure and increasing demand for antibiotics also drive economic growth[1].

Future Outlook

The future outlook for the cefotetan disodium API market is positive, driven by increasing demand and advancements in pharmaceutical technology. However, addressing the challenges of antibiotic resistance and regulatory compliance will be crucial for sustained growth.

Key Takeaways

• The cefotetan disodium API market is projected to grow at a CAGR of around 5% until 2030.
• Key players include ACS Dobfar, Zhejiang East Asia Pharmaceutical, and others.
• The market is segmented by type (purity levels) and application (primarily injections).
• Pharmacokinetic studies highlight the drug's efficacy and safety profile.
• Market drivers include increasing demand for antibiotics and advancements in technology.
• Challenges include antibiotic resistance and regulatory hurdles.

FAQs

Q: What are the main applications of cefotetan disodium? A: The main applications of cefotetan disodium include injections and other medical uses for treating bacterial infections.

Q: Who are the key players in the cefotetan disodium API market? A: The key players include ACS Dobfar, Zhejiang East Asia Pharmaceutical, Jeil Pharmaceutical, Xi'an Ruixi Biological Technology, and Beijing Mega Pharmaceutical Science and Technology.

Q: What is the projected growth rate of the cefotetan disodium API market? A: The market is projected to grow at a CAGR of around 5% until 2030.

Q: What are the potential side effects of cefotetan disodium? A: Potential side effects include hemolytic anemia and Clostridium difficile-associated diarrhea.

Q: How does renal impairment affect the pharmacokinetics of cefotetan disodium? A: Renal impairment prolongs the plasma half-life of cefotetan disodium, necessitating a reduced dosing schedule based on creatinine clearance[2].

Cited Sources:

1. Valuates Reports: Cefotetan Disodium API - Market, Report Size, Worth, Revenue...
2. FDA Label: CEFOTAN™ (cefotetan for Injection, USP)
3. NCBI: Pharmacokinetics and Tolerability of Single and Multiple Intravenous Doses of Cefotetan Disodium in Healthy Chinese Volunteers.
4. Market Research Reports: Global Cefotetan Disodium API Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030.