CEFAZOLIN SODIUM - Generic Drug Details

What are the generic drug sources for cefazolin sodium and what is the scope of patent protection?

Cefazolin sodium is the generic ingredient in eight branded drugs marketed by Glaxosmithkline, Baxter Hlthcare, B Braun, Abraxis Pharm, Acs Dobfar, Aurobindo Pharma, Bedford, Cephazone Pharma, Dr Reddys, Facta Farma, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Hospira, Hospira Inc, Qilu, Samson Medcl, Sandoz, Steri Pharma, Teva Pharms, Lilly, Hq Spclt Pharma, and Baxter Hlthcare Corp, and is included in forty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for cefazolin sodium. Twenty suppliers are listed for this compound.

Summary for CEFAZOLIN SODIUM

US Patents:	0
Tradenames:	8
Applicants:	23
NDAs:	41
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	8
Patent Applications:	4,740
What excipients (inactive ingredients) are in CEFAZOLIN SODIUM?	CEFAZOLIN SODIUM excipients list
DailyMed Link:	CEFAZOLIN SODIUM at DailyMed

Recent Clinical Trials for CEFAZOLIN SODIUM

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

Sponsor	Phase
University of California, Riverside	Phase 2/Phase 3
HK Surgical, Inc.	Phase 2/Phase 3
University of British Columbia	Early Phase 1

See all CEFAZOLIN SODIUM clinical trials

Pharmacology for CEFAZOLIN SODIUM

Drug Class

Cephalosporin Antibacterial

Medical Subject Heading (MeSH) Categories for CEFAZOLIN SODIUM

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for CEFAZOLIN SODIUM

J01DB	First-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for CEFAZOLIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abraxis Pharm	CEFAZOLIN SODIUM	cefazolin sodium	INJECTABLE;INJECTION	062688-003	Nov 17, 1986		DISCN	No	No
Baxter Hlthcare Corp	CEFAZOLIN IN DEXTROSE	cefazolin sodium	SOLUTION;INTRAVENOUS	207131-001	Aug 7, 2015		RX	Yes	Yes
Sandoz	CEFAZOLIN SODIUM	cefazolin sodium	INJECTABLE;INJECTION	062831-003	Sep 25, 1992	AP	RX	No	No
Qilu	CEFAZOLIN SODIUM	cefazolin sodium	INJECTABLE;INJECTION	203661-003	Jan 24, 2024		RX	No	No
Sandoz	CEFAZOLIN SODIUM	cefazolin sodium	INJECTABLE;INJECTION	062831-002	Dec 9, 1988	AP	RX	No	No
B Braun	CEFAZOLIN AND DEXTROSE	cefazolin sodium	INJECTABLE;INJECTION	050779-001	Jul 27, 2000		DISCN	No	No
Glaxosmithkline	ANCEF	cefazolin sodium	INJECTABLE;INJECTION	050461-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

CEFAZOLIN SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Cefazolin Sodium

Market Overview

The global cefazolin sodium market is experiencing significant growth, driven by several key factors. Cefazolin sodium, a first-line antibiotic used to treat various bacterial infections and for surgical prophylaxis, is in high demand due to its efficacy and the rising prevalence of infectious diseases[1][3][4].

Market Size and Projections

As of 2023, the global cefazolin sodium market was valued at USD 100 million. It is projected to reach USD 147 million by 2031, growing at a compound annual growth rate (CAGR) of 5% from 2024 to 2031[1].

Growth Drivers

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

Increasing Prevalence of Infectious Diseases

The global rise in bacterial infections, particularly in surgical and hospital settings, is a major driver. Hospital-acquired infections and the need for effective preventive antibiotics are boosting demand[1][3].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in emerging economies, and advancements in pharmaceutical production are supporting market expansion. Government initiatives in countries like India and China are also contributing to the growth[1][3].

Strategic Partnerships and R&D

Major pharmaceutical companies are investing in research and development to improve the efficacy of cefazolin sodium and minimize its side effects. Strategic partnerships, such as the one between Premier Inc. and Apotex Corp., are securing the supply of antibiotics and driving market growth[1][3].

Demographic Factors

The ageing global population, which is more prone to illnesses, is another significant factor. Adults are the major end-users of cefazolin sodium, and this segment is expected to retain its dominance throughout the forecast period[3].

Regional Outlook

The global cefazolin sodium market is segmented geographically, with the Asia-Pacific region anticipated to hold the major share. This is due to the increasing research and development activities in the healthcare sector, the presence of key market players like CSPC Pharmaceutical Group Ltd. and LKPC Pharmaceutical Co. Ltd., and government initiatives in countries such as China and India[3][4].

Competitive Landscape

The market is highly competitive, with several major players contributing to its growth. Companies like CSPC Pharmaceutical Group Ltd., Dun& Bradstreet, Inc., HISUN USA Ltd., Pfizer Inc., and LKPC Pharmaceutical Co. Ltd. are adopting strategies such as mergers and acquisitions, collaborations, and new product launches to stay competitive[3][4].

Market Segments

The market is segmented based on type, application, and geography. The antimicrobial drugs segment accounted for a noticeable share of the global market in 2023 and is projected to experience significant growth. The adult segment is expected to expand at a significant CAGR, retaining its position throughout the forecast period[3][4].

Challenges and Restraints

Despite the positive growth trajectory, the market faces several challenges:

Side Effects

Side effects such as diarrhea, loss of appetite, and the potential for pseudomembranous colitis are restraining factors for the market growth[3].

Antimicrobial Resistance

The rising human resistance to antimicrobial drugs is a significant concern. According to the CDC, around 2 million people die every year globally due to antimicrobial drug resistance, which could impact the long-term growth of the market[3].

Regulatory and Safety Issues

The need for strict regulatory compliance and the control of drug impurities are critical. Studies have highlighted the importance of evaluating the toxicity of cefazolin sodium impurities to ensure drug safety[5].

Financial Performance and Projections

• Revenue Growth: The market is expected to grow from USD 100 million in 2023 to USD 147 million by 2031, indicating a steady financial trajectory[1].
• CAGR: A CAGR of 5% from 2024 to 2031 reflects a stable and growing market[1].
• Regional Contributions: The Asia-Pacific region is expected to contribute significantly to the market's financial performance due to its large market share and growing healthcare sector[3].

Key Takeaways

• The global cefazolin sodium market is driven by the increasing prevalence of infectious diseases and advancements in healthcare infrastructure.
• Strategic partnerships and R&D investments are crucial for market growth.
• The Asia-Pacific region is anticipated to hold the major share of the market.
• Despite growth, the market faces challenges such as side effects and antimicrobial resistance.
• The adult segment is expected to dominate the market throughout the forecast period.

FAQs

Q: What is the projected market size of cefazolin sodium by 2031? A: The global cefazolin sodium market is expected to reach USD 147 million by 2031[1].

Q: What is the CAGR of the cefazolin sodium market from 2024 to 2031? A: The market is expected to grow at a CAGR of 5% from 2024 to 2031[1].

Q: Which region is anticipated to hold the major share in the global cefazolin sodium market? A: The Asia-Pacific region is anticipated to hold the major share in the global cefazolin sodium market[3].

Q: What are the major factors driving the growth of the cefazolin sodium market? A: The increasing prevalence of infectious diseases, advancements in healthcare infrastructure, and strategic partnerships are major drivers[1][3].

Q: What are some of the challenges facing the cefazolin sodium market? A: Side effects, antimicrobial resistance, and regulatory and safety issues are significant challenges[3][5].

Cited Sources:

1. Market Research Intellect - Global Cefazolin Sodium Market Size and Forecast
2. FDA.report - Cefazolin Sodium Injection, Solution
3. OMR Global - Cefazolin Sodium Market Trends, Share, Global Industry Report and Forecast
4. Cognitive Market Research - Cefazolin Sodium Market Report 2024 (Global Edition)
5. PMC - Embryo and Developmental Toxicity of Cefazolin Sodium Impurities