Oxacillin sodium - Generic Drug Details

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

Oxacillin sodium is the generic ingredient in four branded drugs marketed by Glaxosmithkline, Ani Pharms, Apothecon, Teva, Baxter Hlthcare, Elkins Sinn, Eugia Pharma Speclts, Fresenius Kabi Usa, Hospira, Istituto Bio Ita Spa, Piramal Critical, Sagent Pharms, Sandoz, Steriscience Speclts, Watson Labs Inc, and Wockhardt Bio Ag, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for oxacillin sodium. Seven suppliers are listed for this compound.

Summary for oxacillin sodium

US Patents:	0
Tradenames:	4
Applicants:	16
NDAs:	31
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	2
Patent Applications:	6,571
What excipients (inactive ingredients) are in oxacillin sodium?	oxacillin sodium excipients list
DailyMed Link:	oxacillin sodium at DailyMed

Recent Clinical Trials for oxacillin sodium

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

Sponsor	Phase
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2
Federal University of São Paulo	Phase 4

See all oxacillin sodium clinical trials

Pharmacology for oxacillin sodium

Drug Class

Penicillin-class Antibacterial

Medical Subject Heading (MeSH) Categories for oxacillin sodium

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for oxacillin sodium

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 oxacillin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	BACTOCILL	oxacillin sodium	INJECTABLE;INJECTION	062736-001	Dec 19, 1986		DISCN	No	No
Watson Labs Inc	OXACILLIN SODIUM	oxacillin sodium	INJECTABLE;INJECTION	062856-002	Oct 26, 1988		DISCN	No	No
Sandoz	OXACILLIN SODIUM	oxacillin sodium	POWDER;INTRAVENOUS	062737-001	Dec 23, 1986		DISCN	No	No
Glaxosmithkline	BACTOCILL	oxacillin sodium	INJECTABLE;INJECTION	061334-006	Mar 26, 1982		DISCN	No	No
Glaxosmithkline	BACTOCILL	oxacillin sodium	CAPSULE;ORAL	062241-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Baxter Hlthcare	BACTOCILL IN PLASTIC CONTAINER	oxacillin sodium	INJECTABLE;INJECTION	050640-001	Oct 26, 1989		RX	Yes	Yes
Apothecon	PROSTAPHLIN	oxacillin sodium	FOR SOLUTION;ORAL	050194-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Oxacillin sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Oxacillin Sodium

Introduction

Oxacillin sodium, a semisynthetic penicillin antibiotic, is widely used in the treatment of bacterial infections, particularly those caused by gram-positive organisms. This article delves into the market dynamics, financial trajectory, and key aspects of the oxacillin sodium market.

Market Size and Growth

The global oxacillin sodium market has been experiencing steady growth driven by increasing demand for effective antibiotics to combat resistant bacterial infections. As of 2018, the global oxacillin sodium salt market was valued at a significant amount, and it is projected to expand at a compound annual growth rate (CAGR) from 2019 to 2025[4].

Market Segmentation

The oxacillin sodium market can be segmented based on several factors:

By Application

• Gram-Positive Bacterial Infections: Oxacillin sodium is primarily used to treat infections caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA)[3].
• Research and Development: It is also used in studies of mechanisms of resistance to penicillinase and antimicrobial susceptibility[5].

By Geography

• The market is distributed across various regions, with significant demand in areas where antibiotic resistance is a major concern.
• Emerging markets are expected to contribute substantially to the growth due to increasing healthcare expenditure and improving healthcare infrastructure.

By Distribution Channel

• Hospitals and Clinics: The primary distribution channels include hospitals, clinics, and other healthcare facilities.
• Pharmacies and Retail Stores: Oxacillin sodium is also available through pharmacies and retail stores, although this is less common due to its prescription-only status.

Competitive Landscape

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

Major Manufacturers

• Baxter Healthcare Corporation: Known for its brand Bactocill, Baxter is a significant player in the market[3].
• Bristol-Myers Squibb: With brands like Prostaphlin and Staficilin-N, Bristol-Myers Squibb also holds a substantial market share[3].
• Other Players: Companies such as Armas Pharmaceuticals, AGILA SPECIALTIES PRIVATE LIMITED, and Wockhardt also contribute to the market[3].

Pricing and Cost

The pricing of oxacillin sodium varies based on the dosage strength and the manufacturer. Here are some examples:

• 1 gm vial: Typically priced around $12.41 USD each[3].
• 2 gm vial: Priced around $24.08 USD each[3].
• Bulk and Custom Formats: Prices can vary significantly depending on the quantity and specific requirements[5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of oxacillin sodium:

Approval and Compliance

• Oxacillin sodium is approved for use in various countries and must comply with local regulatory standards.
• Manufacturers must adhere to strict guidelines regarding production, labeling, and distribution[2].

Safety and Efficacy

• Regulatory bodies closely monitor the safety and efficacy of oxacillin sodium, ensuring it meets the required standards for patient use[2].

Market Trends

Several trends are influencing the oxacillin sodium market:

Increasing Antibiotic Resistance

• The rise in antibiotic-resistant bacteria is driving the demand for effective antibiotics like oxacillin sodium[3].

Advancements in Healthcare

• Improvements in healthcare infrastructure and increasing healthcare expenditure in emerging markets are boosting the demand for oxacillin sodium[4].

Research and Development

• Continuous research into the mechanisms of resistance and antimicrobial susceptibility is expanding the applications of oxacillin sodium[5].

Financial Performance

The financial performance of the oxacillin sodium market is robust, driven by consistent demand and expanding applications:

Revenue Forecasts

• The market is expected to grow significantly over the forecast period, driven by increasing demand and new applications[4].

Profit Margins

• Manufacturers are experiencing decent profit margins due to the high demand and relatively stable production costs[3].

Challenges and Opportunities

Despite the positive outlook, the market faces several challenges and opportunities:

Challenges

• Antibiotic Resistance: The ongoing issue of antibiotic resistance poses a significant challenge to the long-term viability of oxacillin sodium[3].
• Regulatory Hurdles: Strict regulatory requirements can sometimes delay market entry or affect production[2].

Opportunities

• Emerging Markets: Growing healthcare needs in emerging markets present significant opportunities for expansion[4].
• Research Applications: The use of oxacillin sodium in research offers additional revenue streams and opportunities for innovation[5].

Key Takeaways

• The oxacillin sodium market is growing due to increasing demand for effective antibiotics against gram-positive bacteria.
• The market is segmented by application, geography, and distribution channel.
• Major manufacturers like Baxter Healthcare Corporation and Bristol-Myers Squibb dominate the market.
• Pricing varies based on dosage strength and manufacturer.
• Regulatory compliance is crucial for market participation.
• Trends such as increasing antibiotic resistance and advancements in healthcare are driving market growth.
• Financial performance is robust, with significant revenue forecasts and decent profit margins.
• Challenges include antibiotic resistance and regulatory hurdles, while opportunities lie in emerging markets and research applications.

FAQs

Q: What is oxacillin sodium used for? A: Oxacillin sodium is used primarily to treat bacterial infections caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA)[3].

Q: Who are the major manufacturers of oxacillin sodium? A: Major manufacturers include Baxter Healthcare Corporation, Bristol-Myers Squibb, Armas Pharmaceuticals, and others[3].

Q: How is oxacillin sodium administered? A: Oxacillin sodium is administered intravenously or intramuscularly, with peak serum levels achieved approximately 5 minutes after intravenous administration[2].

Q: What are the potential side effects of oxacillin sodium? A: Potential side effects include renal tubular damage, interstitial nephritis, pseudomembranous colitis, and gastrointestinal reactions[2].

Q: What is the projected growth rate of the oxacillin sodium market? A: The market is projected to expand at a CAGR from 2019 to 2025, driven by increasing demand and new applications[4].

Sources

1. Oxacillin Sodium for Injection Market 2024: Research by Size, Advanced Competitive Landscape, and Revenue Forecasts by 2032 - Southeast News Channel Nebraska.
2. Oxacillin for Injection, USP Rx only - DailyMed.
3. Oxacillin: Uses, Interactions, Mechanism of Action - DrugBank Online.
4. Oxacillin sodium salt Market Size, Share, Trend and Forecast to 2025 - Prof-Research.
5. Oxacillin sodium salt, 95% - Thermo Fisher Scientific.