CEFUROXIME SODIUM - Generic Drug Details

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

Cefuroxime sodium is the generic ingredient in seven branded drugs marketed by B Braun, Acs Dobfar Spa, Fresenius Kabi Usa, Hikma, Hospira Inc, Teva Pharms, Watson Labs Inc, Samson Medcl, Acs Dobfar, Lilly, and Pai Holdings Pharm, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for cefuroxime sodium. Three suppliers are listed for this compound.

Summary for CEFUROXIME SODIUM

US Patents:	0
Tradenames:	7
Applicants:	11
NDAs:	20
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	3
Patent Applications:	1,382
What excipients (inactive ingredients) are in CEFUROXIME SODIUM?	CEFUROXIME SODIUM excipients list
DailyMed Link:	CEFUROXIME SODIUM at DailyMed

Recent Clinical Trials for CEFUROXIME SODIUM

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

Sponsor	Phase
Hospital Universitari Vall d'Hebron Research Institute	Phase 4
University Hospital, Basel, Switzerland	Phase 4
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 2/Phase 3

See all CEFUROXIME SODIUM clinical trials

Pharmacology for CEFUROXIME SODIUM

Drug Class

Cephalosporin Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for CEFUROXIME SODIUM

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

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for CEFUROXIME SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Samson Medcl	CEFUROXIME SODIUM IN PLASTIC CONTAINER	cefuroxime sodium	INJECTABLE;INJECTION	065251-001	Dec 30, 2009		DISCN	No	No
Watson Labs Inc	CEFUROXIME SODIUM	cefuroxime sodium	INJECTABLE;INJECTION	064036-001	Feb 26, 1993		DISCN	No	No
Acs Dobfar Spa	CEFUROXIME SODIUM	cefuroxime sodium	INJECTABLE;INJECTION	064124-001	May 30, 1997		DISCN	No	No
Pai Holdings Pharm	ZINACEF	cefuroxime sodium	INJECTABLE;INJECTION	050558-003	Oct 19, 1983		DISCN	Yes	No
Watson Labs Inc	CEFUROXIME SODIUM	cefuroxime sodium	INJECTABLE;INJECTION	064035-002	Feb 26, 1993		DISCN	No	No
Fresenius Kabi Usa	CEFUROXIME SODIUM	cefuroxime sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	065001-001	May 30, 2001		DISCN	No	No

CEFUROXIME SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cefuroxime Sodium

Introduction

Cefuroxime sodium, a broad-spectrum cephalosporin antibiotic, has been a crucial component in the global healthcare system, particularly in the treatment of various bacterial infections. The market for cefuroxime sodium is experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The cefuroxime sodium market, including both API sales and injection formulations, is anticipated to witness substantial growth over the forecast period from 2023 to 2031. The Cefuroxime Sodium API Sales Market is expected to reach a significant value in USD billion by 2031, reflecting a robust growth rate from its current value in 2023[1].

Similarly, the Cefuroxime Sodium for Injection Market is projected to develop revenue and exponential market growth at a remarkable CAGR during the same period. This growth is attributed to the increasing incidence of bacterial infections globally and the expanding healthcare access in developing countries[2].

Market Segmentation

The market for cefuroxime sodium is segmented based on several criteria:

Type

• For API sales, the market is segmented into powder and liquid forms[1].
• For injection formulations, the market is categorized by dosage strengths such as 0.5g, 0.75g, 1g, and 1.5g[2].

Application

• The primary application of cefuroxime sodium is as an antibiotic, treating a wide range of bacterial infections including respiratory tract infections, urinary tract infections, skin infections, and soft tissue infections[4].

Geography

• The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region presents unique market dynamics influenced by local healthcare infrastructure, regulatory environments, and economic conditions[1][2].

Drivers of Market Growth

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

Increasing Incidence of Infections

The rising global incidence of bacterial infections is a primary driver. As infections become more prevalent, the demand for effective antibiotics like cefuroxime sodium increases[4].

Antibiotic Resistance

The growing issue of antibiotic resistance has made broad-spectrum antibiotics like cefuroxime sodium more critical. These antibiotics are often used in empirical therapy for serious bacterial infections, ensuring their continued relevance[4].

Expansion of Generic Versions

The availability of generic versions of cefuroxime sodium injection has significantly expanded its accessibility, particularly in price-sensitive markets. This has made the drug more affordable and accessible to a broader range of healthcare providers and patients[4].

Strategic Partnerships and Collaborations

Global pharmaceutical companies are entering strategic partnerships and collaborations to expand their reach in emerging markets. This ensures that cefuroxime sodium injection is accessible in regions with high infection rates and limited healthcare access[4].

Market Challenges and Restraints

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

Manufacturing Delays and Shortages

Historical manufacturing delays and increased demand have led to shortages of cefuroxime sodium injection. For instance, Sagent experienced a shortage due to manufacturing delays, and Teligent discontinued certain presentations in 2018[5].

Regulatory and Economic Factors

The market is influenced by regulatory changes, economic conditions, and the political landscapes of various countries. These external factors can impact the production, pricing, and distribution of cefuroxime sodium[2].

Competitive Landscape

The competitive landscape of the cefuroxime sodium market is characterized by the presence of both established and emerging players. Key companies include GlaxoSmithKline plc, Hikma Pharmaceuticals plc, Sandoz International GmbH (Novartis AG), Teva Pharmaceutical Industries Ltd., and Aurobindo Pharma Limited, among others. These companies are involved in various market-related activities such as recent initiatives, collaborations, mergers and acquisitions, and new product launches[1][2].

Investment Opportunities

The growing demand for cefuroxime sodium presents several investment opportunities:

Manufacturing and Distribution

Investing in the production of generic versions of cefuroxime sodium injection and partnering with local healthcare providers to distribute the drug can be lucrative, especially in regions where cost-effective healthcare is a priority[4].

Research and Development

Investing in R&D to explore new indications for cefuroxime or developing novel drug delivery systems can offer significant returns as the market continues to evolve[4].

Market Outlook and Trends

The market outlook for cefuroxime sodium is positive, with several trends shaping its future:

Antibiotic Stewardship

The growing emphasis on antibiotic stewardship programs ensures that cefuroxime is used appropriately, preserving its effectiveness for years to come[4].

Ongoing Clinical Research

Clinical research is ongoing to explore new indications for cefuroxime sodium injection, potentially expanding its use to treat additional types of bacterial infections[4].

Expansion of Healthcare Access

The expansion of healthcare infrastructure in emerging markets is increasing the demand for injectable antibiotics like cefuroxime sodium[4].

Key Takeaways

• The cefuroxime sodium market is expected to grow significantly from 2023 to 2031, driven by increasing bacterial infections and expanding healthcare access.
• The market is segmented by type, application, and geography, with a strong presence of both branded and generic formulations.
• Key drivers include the rise in infections, antibiotic resistance, and the availability of generic versions.
• Challenges such as manufacturing delays and regulatory factors need to be addressed.
• Investment opportunities exist in manufacturing, distribution, and R&D.

FAQs

Q: What are the primary drivers of the cefuroxime sodium market growth? A: The primary drivers include the increasing incidence of bacterial infections, the growing issue of antibiotic resistance, and the expansion of generic versions of cefuroxime sodium injection.

Q: Which regions are expected to see significant growth in the cefuroxime sodium market? A: Regions such as Asia-Pacific, South America, and the Middle-East and Africa are expected to see significant growth due to expanding healthcare access and high infection rates.

Q: What are the main challenges facing the cefuroxime sodium market? A: The main challenges include manufacturing delays, shortages, and regulatory and economic factors that can impact production and distribution.

Q: Which companies are key players in the cefuroxime sodium market? A: Key players include GlaxoSmithKline plc, Hikma Pharmaceuticals plc, Sandoz International GmbH (Novartis AG), Teva Pharmaceutical Industries Ltd., and Aurobindo Pharma Limited.

Q: What investment opportunities are available in the cefuroxime sodium market? A: Investment opportunities exist in the production of generic versions, distribution partnerships, and research and development to explore new indications and drug delivery systems.

Cited Sources:

1. Market Research Intellect, "Cefuroxime Sodium API Sales Market Size, Scope And Forecast".
2. Market Research Intellect, "Global Cefuroxime Sodium for Injection Market Size, Trends and Forecast".
3. Cognitive Market Research, "Cefuroxime Sodium Market Report 2024 (Global Edition)".
4. Market Research Intellect, "Rising Global Infections Boost Demand for Cefuroxime Sodium Injection in Healthcare".
5. American Society of Health-System Pharmacists (ASHP), "Drug Shortage Detail: Cefuroxime Sodium Injection".