NAFCILLIN SODIUM - Generic Drug Details

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

Nafcillin sodium is the generic ingredient in five branded drugs marketed by Wyeth Ayerst, Antibiotice, Apothecon, Eugia Pharma Speclts, Fresenius, Istituto Bio Ita Spa, Sagent Pharms, Sandoz, Steriscience Speclts, Watson Labs Inc, Glaxosmithkline, and Baxter Hlthcare, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for nafcillin sodium. Ten suppliers are listed for this compound.

Summary for NAFCILLIN SODIUM

US Patents:	0
Tradenames:	5
Applicants:	12
NDAs:	23
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	1
Patent Applications:	2,805
What excipients (inactive ingredients) are in NAFCILLIN SODIUM?	NAFCILLIN SODIUM excipients list
DailyMed Link:	NAFCILLIN SODIUM at DailyMed

Recent Clinical Trials for NAFCILLIN 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 NAFCILLIN SODIUM clinical trials

Pharmacology for NAFCILLIN SODIUM

Drug Class

Penicillin-class Antibacterial

Medical Subject Heading (MeSH) Categories for NAFCILLIN SODIUM

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for NAFCILLIN 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 NAFCILLIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Istituto Bio Ita Spa	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	090002-001	Jun 30, 2011	AP	RX	No	No
Fresenius	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	206761-001	Jun 2, 2020	AP	RX	No	No
Antibiotice	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	090560-002	Oct 3, 2011	AP	RX	No	No
Sandoz	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	062527-002	Aug 2, 1984		DISCN	No	No

NAFCILLIN SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nafcillin Sodium

Introduction to Nafcillin Sodium

Nafcillin sodium is a penicillinase-resistant penicillin, widely used in healthcare settings to treat bacterial infections, particularly those caused by resistant bacterial strains. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare professionals.

Clinical Use and Demand

Nafcillin sodium is a go-to choice for clinicians when dealing with resistant bacterial strains. Its effectiveness in treating infections such as methicillin-resistant Staphylococcus aureus (MRSA) drives its demand in healthcare settings[1].

Market Size and Growth

The global nafcillin sodium market has experienced rapid and substantial growth in recent years. Projections indicate continued significant expansion, driven by increasing demand for effective antibiotics to combat antimicrobial resistance (AMR)[4].

Economic Factors Influencing the Market

The antibiotic market, including nafcillin sodium, faces unique economic challenges. New antibiotics are urgently needed but are tightly controlled to limit the risk of resistance, which reduces their market potential. Additionally, antibiotics are generally cheaper and taken for shorter periods, making them less lucrative compared to other pharmaceutical categories[3].

Risk-Adjusted Net Present Value (rNPV)

Pharmaceutical companies assess the business case for research and development (R&D) projects based on the rNPV. For antibiotics like nafcillin sodium, the rNPV is significantly lower than for drugs in other therapeutic categories, such as neurological or musculoskeletal drugs. This low rNPV discourages investment in new antibiotic development[3].

Market Incentives and Challenges

The market incentives for developing new antibiotics, including nafcillin sodium, are weak due to several factors:

• High Registration Costs: Economic factors, including high registration costs and limited volume sales, often prevent the marketing of potentially useful antibiotics in many countries[3].
• Low Prices: Antibiotics are generally cheaper, which, combined with shorter treatment durations, results in lower revenue potential[3].
• Consolidation in the Industry: The increasing consolidation in the pharmaceutical industry, with companies like AstraZeneca divesting their antibiotic businesses, further weakens the market for new antibiotic development[3].

Impact of Antimicrobial Resistance (AMR)

The growing issue of AMR exacerbates the challenges in the antibiotic market. The need for new antibiotics is urgent, yet the development and deployment of these drugs are hindered by poor surveillance and stewardship, particularly in high-burden areas. This situation drives the emergence of resistant strains, making the market for antibiotics like nafcillin sodium more complex[3].

Pharmaceutical Company Strategies

Companies involved in the production of nafcillin sodium and other antibiotics are adopting various strategies to navigate these challenges:

• Equitable Pricing Approaches: Some companies, such as Mylan and Cipla, report equitable pricing approaches to ensure access to antibiotics in different markets[3].
• Stewardship and Access Plans: Companies like Entasis are focusing on planning ahead for access and stewardship of clinical-stage candidates to ensure the successful deployment of new antibiotics[3].

Financial Projections and Savings

Despite the challenges, the inclusion of nafcillin sodium and similar antibiotics in preferred formularies can lead to significant savings. For example, Express Scripts' decision to prefer the biosimilar insulin Semglee® over biologic insulin Lantus® is expected to achieve millions in savings, illustrating the potential financial benefits of strategic formulary management[2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of nafcillin sodium. Regulatory approvals and the process of bringing new antibiotics to market are complex and costly. However, initiatives to streamline these processes and incentivize antibiotic development are being explored to address the growing need for effective antimicrobials[3].

Patient and Payer Acceptance

Patient and payer acceptance of biosimilars and generic antibiotics, including nafcillin sodium, is increasing. This acceptance is driven by the need for cost-effective treatments and the growing awareness of the clinical efficacy of these alternatives. Payers, in particular, are showing greater acceptance of biosimilars, which can help in managing healthcare costs[2].

Conclusion

The market dynamics and financial trajectory of nafcillin sodium are influenced by a complex interplay of clinical demand, economic factors, regulatory challenges, and patient and payer acceptance. While the market faces significant challenges, there are opportunities for growth and cost savings through strategic management and innovative approaches to antibiotic development and deployment.

Key Takeaways

• Clinical Demand: Nafcillin sodium is crucial in treating resistant bacterial infections.
• Economic Challenges: Low rNPV, high registration costs, and low prices hinder new antibiotic development.
• AMR Impact: Growing AMR exacerbates the need for new antibiotics but complicates their development and deployment.
• Company Strategies: Equitable pricing and stewardship plans are key strategies for navigating market challenges.
• Financial Projections: Strategic formulary management can lead to significant savings.
• Regulatory Environment: Complex regulatory processes affect the market dynamics of antibiotics.

FAQs

What is nafcillin sodium used for?

Nafcillin sodium is used to treat bacterial infections, particularly those caused by resistant bacterial strains such as MRSA.

Why is the development of new antibiotics like nafcillin sodium challenging?

The development of new antibiotics is challenging due to low rNPV, high registration costs, low prices, and the need for tight control to prevent resistance.

How does AMR affect the market for nafcillin sodium?

AMR increases the urgency for new antibiotics but also complicates their development and deployment due to poor surveillance and stewardship.

What strategies are companies using to navigate the challenges in the antibiotic market?

Companies are using equitable pricing approaches and focusing on access and stewardship plans for clinical-stage candidates.

How does the regulatory environment impact the market for nafcillin sodium?

The regulatory environment affects the market through complex and costly approval processes, but initiatives to streamline these processes are being explored.

Sources

1. Patsnap Synapse - What is Nafcillin Sodium used for?
2. RxStrategies - Clinical Insights: October 26, 2021
3. Access to Medicine Foundation - Antimicrobial Resistance Benchmark 2018
4. Market Research Intellect - Global Nafcillin Sodium Market Size, Scope And Forecast Report
5. Drugs.com - Nafcillin: Package Insert / Prescribing Information