DICLOXACILLIN SODIUM - Generic Drug Details

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

Dicloxacillin sodium is the generic ingredient in four branded drugs marketed by Aurobindo Pharma, Chartwell Rx, Teva, Glaxosmithkline, Wyeth Ayerst, and Apothecon, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for dicloxacillin sodium. Eight suppliers are listed for this compound.

Summary for DICLOXACILLIN SODIUM

US Patents:	0
Tradenames:	4
Applicants:	6
NDAs:	9
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	1
Patent Applications:	1,744
What excipients (inactive ingredients) are in DICLOXACILLIN SODIUM?	DICLOXACILLIN SODIUM excipients list
DailyMed Link:	DICLOXACILLIN SODIUM at DailyMed

Recent Clinical Trials for DICLOXACILLIN SODIUM

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 DICLOXACILLIN SODIUM clinical trials

Pharmacology for DICLOXACILLIN SODIUM

Drug Class

Penicillin-class Antibacterial

Medical Subject Heading (MeSH) Categories for DICLOXACILLIN SODIUM

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for DICLOXACILLIN SODIUM

J01CF	Beta-lactamase resistant penicillins
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01CF	Beta-lactamase resistant penicillins
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01CF	Beta-lactamase resistant penicillins
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for DICLOXACILLIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apothecon	DYNAPEN	dicloxacillin sodium	FOR SUSPENSION;ORAL	050337-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Apothecon	DICLOXACILLIN SODIUM	dicloxacillin sodium	FOR SUSPENSION;ORAL	061455-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Chartwell Rx	DICLOXACILLIN SODIUM	dicloxacillin sodium	CAPSULE;ORAL	061454-001	Approved Prior to Jan 1, 1982		DISCN	No	No

DICLOXACILLIN SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Dicloxacillin Sodium

Introduction to Dicloxacillin Sodium

Dicloxacillin sodium is a penicillin antibiotic that targets penicillin-binding proteins (PBPs) to exert its therapeutic effects, primarily against gram-positive bacteria, including Staphylococcus aureus. Approved for use since 1968, it is widely used in treating various bacterial infections, including skin, respiratory, and musculoskeletal diseases[3].

Market Size and Growth Projections

The dicloxacillin sodium market has experienced rapid and substantial growth in recent years and is projected to continue this trend from 2023 to 2031. The market size is expected to expand significantly, driven by the increasing incidence of bacterial illnesses and the need for potent medications. The forecast period indicates robust growth rates, with the market valued in USD million across various segments such as type (0.5g, 0.375g, 0.25g) and application (Staphylococcal skin infections, pneumonia, septicemia, empirical treatment of endocarditis, etc.)[1][4].

Key Drivers of Market Growth

Several factors are driving the expansion of the dicloxacillin sodium market:

Increasing Prevalence of Bacterial Infections

The rising incidence of bacterial illnesses, particularly those caused by penicillinase-producing staphylococci, is a major driver. This increase in infections necessitates the use of effective antibiotics like dicloxacillin sodium[4].

Growing Awareness of Antibiotic Resistance

Cautious prescription practices and growing awareness of antibiotic resistance have led to a greater demand for antibiotics that are effective against resistant bacteria. Dicloxacillin sodium's efficacy against such bacteria makes it a preferred choice[4].

Advances in Pharmaceutical R&D

Improvements in the quality and availability of dicloxacillin sodium due to advances in pharmaceutical research and development are also driving market growth. Better formulations and more effective production techniques enhance the drug's availability and efficacy[4].

Government Initiatives and Healthcare Policies

Government initiatives and healthcare policies aimed at controlling bacterial infections support the use of dicloxacillin sodium. These policies encourage the development and use of effective antibiotics, contributing to market expansion[4].

Market Segmentation

The dicloxacillin sodium market is segmented based on several criteria:

Type

The market is segmented by the type of dicloxacillin sodium, including 0.5g, 0.375g, and 0.25g formulations. Each type has different applications and market demands[1].

Application

Dicloxacillin sodium is used in various applications, including the treatment of Staphylococcal skin infections and cellulitis, pneumonia, septicemia, empirical treatment of endocarditis, and other infections. The demand for the drug varies across these applications[1].

Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own market dynamics and growth prospects[1].

Competitive Landscape

The dicloxacillin sodium market is characterized by a competitive landscape with several key players:

Major Companies

Companies such as Star, CSPC, SPH, North China Pharma, China General Technology, Sinopharm Group, Aurobindo Pharma, Teva, Glaxo Smith Kline, Apothecon Pharma, Sandoz, Pfizer, Orion, and Centrient Pharma are prominent in the market. These companies engage in various strategies such as mergers and acquisitions, new product launches, and partnerships to maintain their market positions[1][4].

Mergers and Acquisitions

The market is witnessing a wave of mergers and acquisitions as companies seek to consolidate their market positions, expand their product portfolios, and leverage synergies to drive growth and competitiveness[4].

Challenges and Restraints

Despite the positive outlook, the market faces several challenges:

Antibiotic Resistance

The growing issue of antibiotic resistance is a significant challenge. The overuse or misuse of antibiotics can lead to the development of resistant bacterial strains, reducing the efficacy of dicloxacillin sodium[2].

Side Effects and Adverse Reactions

Dicloxacillin sodium can cause side effects such as Clostridium difficile associated diarrhea (CDAD), esophageal burning, esophagitis, and esophageal ulceration, particularly if not taken properly. These adverse reactions can impact market growth[2].

Financial Trajectory

The financial trajectory of the dicloxacillin sodium market is promising:

Revenue Projections

The market is expected to generate significant revenue throughout the forecast period (2023-2031), measured in USD million. The revenue growth is driven by the increasing demand for effective antibiotics and the expanding healthcare infrastructure globally[1].

Investment and Funding

The market attracts substantial investment due to its growth potential. Pharmaceutical companies and investors are keen on funding research and development to improve the quality and availability of dicloxacillin sodium, further driving market expansion[4].

Regional Market Analysis

The dicloxacillin sodium market varies significantly across different regions:

North America and Europe

These regions have mature markets with well-established healthcare infrastructures. The demand for dicloxacillin sodium is driven by the need for effective treatments against bacterial infections and the presence of stringent regulations to combat antibiotic resistance[1][4].

Asia-Pacific

The Asia-Pacific region is experiencing rapid growth due to the increasing urban population and the rising healthcare infrastructure in emerging economies. This region presents significant opportunities for market expansion[4].

Key Takeaways

• The dicloxacillin sodium market is projected to experience robust growth from 2023 to 2031.
• The market is driven by the increasing prevalence of bacterial infections and the need for potent antibiotics.
• Advances in pharmaceutical R&D and supportive government initiatives are key factors.
• The market is segmented by type, application, and geography, with various key players competing in the space.
• Challenges such as antibiotic resistance and side effects need to be addressed.

FAQs

Q: What is dicloxacillin sodium used for? Dicloxacillin sodium is used in the treatment of infections caused by penicillinase-producing staphylococci, including Staphylococcal skin infections, pneumonia, septicemia, and empirical treatment of endocarditis[2].

Q: What are the key drivers of the dicloxacillin sodium market? The key drivers include the increasing prevalence of bacterial infections, growing awareness of antibiotic resistance, advances in pharmaceutical R&D, and supportive government initiatives[4].

Q: Which regions are major players in the dicloxacillin sodium market? North America, Europe, and the Asia-Pacific region are significant players in the market, each with its own market dynamics and growth prospects[1].

Q: What are the potential challenges facing the dicloxacillin sodium market? Challenges include antibiotic resistance, side effects such as CDAD, and the need for cautious prescription practices to maintain the drug's efficacy[2].

Q: How is the competitive landscape of the dicloxacillin sodium market? The market is competitive with several key players engaging in mergers and acquisitions, new product launches, and partnerships to maintain their market positions[1][4].

Cited Sources

1. Market Research Intellect: Global Dicloxacillin Sodium Market Size, Trends and Projections[1].
2. Drugs.com: Dicloxacillin: Package Insert / Prescribing Information[2].
3. Patsnap Synapse: Unleashing the Power of Dicloxacillin sodium - A Comprehensive Review on R&D Breakthroughs[3].
4. OpenPR: Dicloxacillin Sodium Market Size, Share and Forecast By Key Players[4].