CEFEPIME HYDROCHLORIDE - Generic Drug Details

What are the generic sources for cefepime hydrochloride and what is the scope of freedom to operate?

Cefepime hydrochloride is the generic ingredient in six branded drugs marketed by B Braun, Acs Dobfar, Astral, Chartwell Rx, Hikma, Hospira Inc, Qilu, Sagent Pharms Inc, Baxter Hlthcare, Samson Medcl, and Allecra Theraps, and is included in thirteen NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for cefepime hydrochloride. Ten suppliers are listed for this compound.

Summary for CEFEPIME HYDROCHLORIDE

US Patents:	2
Tradenames:	6
Applicants:	11
NDAs:	13
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	61
Patent Applications:	762
What excipients (inactive ingredients) are in CEFEPIME HYDROCHLORIDE?	CEFEPIME HYDROCHLORIDE excipients list
DailyMed Link:	CEFEPIME HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CEFEPIME HYDROCHLORIDE

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

Sponsor	Phase
Biomedical Advanced Research and Development Authority	Phase 3
Meiji Seika Pharma Co., Ltd.	Phase 3
Linical Co., Ltd.	Phase 2

See all CEFEPIME HYDROCHLORIDE clinical trials

Pharmacology for CEFEPIME HYDROCHLORIDE

Drug Class

Cephalosporin Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for CEFEPIME HYDROCHLORIDE

J01DE	Fourth-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for CEFEPIME HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira Inc	CEFEPIME HYDROCHLORIDE	cefepime hydrochloride	INJECTABLE;INJECTION	202268-002	Jul 30, 2012		DISCN	No	No
Hospira Inc	CEFEPIME HYDROCHLORIDE	cefepime hydrochloride	INJECTABLE;INJECTION	065369-003	Jun 18, 2007		DISCN	No	No
Acs Dobfar	CEFEPIME HYDROCHLORIDE	cefepime hydrochloride	INJECTABLE;INJECTION	065441-002	Mar 20, 2008	AP	RX	No	No

CEFEPIME HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cefepime Hydrochloride

Introduction to Cefepime Hydrochloride

Cefepime hydrochloride is a fourth-generation cephalosporin antibiotic used to treat a variety of bacterial infections. It is known for its broad spectrum of activity against both Gram-positive and Gram-negative bacteria. Here, we will delve into the market dynamics and financial trajectory of cefepime hydrochloride.

Market Size and Growth Projections

The cefepime hydrochloride market has witnessed significant growth in recent years and is expected to continue this trend. The market size is categorized based on type (0.5g/Piece, 1.0g/Piece, 2.0g/Piece) and application (Hospital Pharmacy, Retail Pharmacy), as well as geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1].

Forecasts indicate robust growth rates from 2023 to 2031, driven by the increasing demand for effective antibiotics to combat bacterial infections. The market is poised for significant development, with sustained expansion anticipated over the forecasted period[1].

Key Drivers and Restraints

Drivers:

• Increasing Antibiotic Resistance: The rise in antibiotic-resistant bacteria has heightened the need for effective antibiotics like cefepime hydrochloride, driving market growth.
• Advancements in Healthcare: Improvements in healthcare infrastructure and the increasing availability of advanced medical treatments are boosting the demand for cefepime hydrochloride.
• Government Initiatives: Contracts and funding from government agencies, such as the $318 million contract awarded by BARDA for the development and procurement of cefepime-taniborbactam, support the development and commercialization of these antibiotics[2].

Restraints:

• Regulatory Challenges: The FDA's request for additional chemistry, manufacturing, and controls (CMC) data, as seen in the case of cefepime-taniborbactam, can delay market entry and impact financial trajectories[2].
• Competition: The presence of other antibiotics and the ongoing development of new antimicrobial agents can pose competitive challenges.

Market Segmentation

By Type:

• The market is segmented into different strengths such as 0.5g/Piece, 1.0g/Piece, and 2.0g/Piece. Each segment has its own market dynamics and demand patterns, influenced by the severity and type of infections being treated[1].

By Application:

• Hospital pharmacies and retail pharmacies are the primary application segments. Hospital pharmacies tend to have a higher demand due to the treatment of more severe infections, while retail pharmacies cater to outpatient treatments[1].

By Geography:

• The market is geographically segmented into regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region has its own growth trajectory, influenced by local healthcare policies, economic conditions, and disease prevalence[1].

Financial Performance and Revenue Growth

The financial performance of the cefepime hydrochloride market is robust, with steady revenue growth observed in recent years. Excluding COVID-related products, the revenue from innovative drugs, including cefepime hydrochloride, has shown a period-on-period increase. For instance, the pharmaceutical manufacturing segment of companies like Fosun Pharmaceutical has seen revenue from innovative drugs exceed significant figures, contributing to overall revenue growth[3].

Key Players and Partnerships

• Venatorx and Melinta: These companies are actively involved in the development and commercialization of cefepime-taniborbactam, a combination antibiotic that includes cefepime. Their strategic partnerships and licensing agreements, such as the exclusive license agreement with Everest Medicines for Greater China, South Korea, and Southeast Asia, are crucial for expanding market reach[2].
• Fosun Pharmaceutical: This company has seen significant revenue growth from its innovative drugs, including those related to antibiotics. Their financial reports highlight the steady revenue growth in the pharmaceutical manufacturing segment[3].

Regulatory Updates and Clinical Trials

• FDA Approval Process: The FDA's Complete Response Letter (CRL) for cefepime-taniborbactam did not identify clinical safety or efficacy issues but requested additional CMC data. This highlights the rigorous regulatory process that antibiotics must undergo before approval[2].
• Clinical Trials: Cefepime-taniborbactam has completed Phase 3 studies for complicated urinary tract infections (cUTI) and is under review for other indications such as hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP)[2].

Pharmacokinetics and Clinical Relevance

Cefepime hydrochloride's pharmacokinetics are well-studied, with significant renal excretion and the need for dosage adjustments in patients with renal impairment. The drug's ability to cross the inflamed blood-brain barrier and its metabolism to N-methylpyrrolidine (NMP) are important clinical considerations[5].

Market Opportunities and Challenges

Opportunities:

• Growing Demand for Antibiotics: The increasing incidence of bacterial infections and the rise in antibiotic resistance create a significant market opportunity for effective antibiotics like cefepime hydrochloride.
• Emerging Markets: Regions with growing healthcare infrastructure and increasing access to advanced medical treatments offer new market opportunities.

Challenges:

• Antibiotic Resistance: The ongoing challenge of antibiotic resistance requires continuous innovation and development of new antimicrobial agents.
• Regulatory Hurdles: The stringent regulatory environment can delay market entry and impact the financial performance of companies involved in the development and commercialization of these drugs.

Key Takeaways

• The cefepime hydrochloride market is poised for significant growth driven by increasing demand and advancements in healthcare.
• Regulatory challenges, such as the need for additional CMC data, can impact market entry and financial trajectories.
• Strategic partnerships and licensing agreements are crucial for expanding market reach.
• The pharmacokinetics of cefepime hydrochloride require careful consideration, especially in patients with renal impairment.

Frequently Asked Questions (FAQs)

Q: What are the primary applications of cefepime hydrochloride? A: Cefepime hydrochloride is primarily used in hospital pharmacies and retail pharmacies for treating various bacterial infections.

Q: What are the key drivers of the cefepime hydrochloride market? A: The key drivers include increasing antibiotic resistance, advancements in healthcare, and government initiatives supporting the development and procurement of antibiotics.

Q: What regulatory challenges has cefepime-taniborbactam faced? A: Cefepime-taniborbactam faced a Complete Response Letter (CRL) from the FDA requesting additional chemistry, manufacturing, and controls (CMC) data.

Q: How does cefepime hydrochloride's pharmacokinetics impact its clinical use? A: Cefepime hydrochloride's significant renal excretion and the need for dosage adjustments in patients with renal impairment are critical clinical considerations.

Q: What are the market opportunities for cefepime hydrochloride in emerging regions? A: Emerging regions with growing healthcare infrastructure offer significant market opportunities due to increasing access to advanced medical treatments.

Cited Sources:

1. Market Research Intellect: Global Cefepime Hydrochloride for Injection Market Size, Trends ...
2. Venatorx and Melinta: Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam
3. Fosun Pharmaceutical: Interim Report 2024
4. Research and Markets: Global and Chinese Cefepime Hydrochloride / L-arginine Industry Report
5. FDA: MAXIPIME (Cefepime Hydrochloride, USP) for Injection For Intramuscular or Intravenous Administration[5]