NAFCILLIN SODIUM Drug Patent Profile

Which patents cover Nafcillin Sodium, and what generic alternatives are available?

Nafcillin Sodium is a drug marketed by Antibiotice, Apothecon, Eugia Pharma Speclts, Fresenius, Istituto Bio Ita Spa, Onesource Specialty, Sagent Pharms, Sandoz, and Watson Labs Inc. and is included in fifteen NDAs.

The generic ingredient in NAFCILLIN SODIUM is nafcillin sodium. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the nafcillin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nafcillin Sodium

A generic version of NAFCILLIN SODIUM was approved as nafcillin sodium by ISTITUTO BIO ITA SPA on April 20^th, 2011.

Summary for NAFCILLIN SODIUM

US Patents:	0
Applicants:	9
NDAs:	15
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	1,187
DailyMed Link:	NAFCILLIN SODIUM at DailyMed

Recent Clinical Trials for NAFCILLIN SODIUM

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

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de 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
Watson Labs Inc	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	062844-001	Oct 26, 1988		DISCN	No	No
Watson Labs Inc	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	062844-003	Oct 26, 1988		DISCN	No	No
Watson Labs Inc	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	062844-004	Oct 26, 1988		DISCN	No	No
Antibiotice	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	090560-001	Oct 3, 2011	AP	RX	No	No
Sagent Pharms	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	090582-001	Aug 24, 2012	AP	RX	No	No
Sandoz	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	062732-002	Dec 23, 1986		DISCN	No	No
Eugia Pharma Speclts	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	091613-001	Dec 26, 2012	AP	RX	No	Yes

Market Dynamics and Financial Trajectory for Nafcillin Sodium

Last updated: February 19, 2026

What is Nafcillin Sodium and Its Therapeutic Use?

Nafcillin sodium is a beta-lactam antibiotic belonging to the penicillin class. It is primarily used to treat serious bacterial infections caused by penicillinase-producing staphylococci, including methicillin-sensitive strains. The drug is administered intravenously, making it suitable for inpatient treatment.

Current Market Landscape

Market Size and Revenue

The global market for antibiotics, including nafcilin sodium, is characterized by a shift towards targeted therapies driven by rising bacterial resistance. The demand for anti-staphylococcal agents like nafcilin exceeds $2 billion annually. The core markets are North America, Europe, and Asia-Pacific, with North America occupying approximately 40% of the market share due to high healthcare expenditures and prevalent bacterial infections.

Market Segmentation

Segment	Share	Key Factors
Acute bacterial skin infections	35%	Prevalence of MRSA and other resistant strains
Endocarditis and septicemia	30%	IV administration makes it preferred for hospital settings
Osteomyelitis, pneumonia	20%	Demand for effective penicillin-based antibiotics
Other indications	15%	Limited, mainly in hospital environments

Competitive Landscape

Nafcillin is marketed under various brand names (e.g., Nafcil, Unipen) and as a generic. Major manufacturers include Teva, Sandoz, and Fresenius Kabi, which benefit from established manufacturing and distribution networks. The drug faces competition from other antibiotics such as oxacillin, nafcillin, and newer agents like dicloxacillin.

Drivers of Market Growth

• Rising Incidence of Staphylococcal Infections: Healthcare-associated infections (HAIs) driven by resistant bacteria increase the demand for effective IV antibiotics.
• Growth in Hospitalizations: An aging population coupled with increased hospital procedures elevates infection risks, bolstering demand.
• Enhanced Use of Beta-Lactam Antibiotics: Clinical guidelines favor narrow-spectrum agents like nafcilin for penicillin-sensitive infections, supporting sustained usage.

Challenges Impacting Market Trajectory

• Antibiotic Resistance: Emerging resistance to beta-lactam antibiotics diminishes the efficacy of nafcilin, prompting healthcare providers to shift towards alternative agents.
• Regulatory and Patent Issues: Although many formulations are generic, patent expirations reduce margins for original developers and limit innovation incentives.
• Stringent Approval Processes: Regulatory bodies in the U.S. and Europe tighten standards for post-marketing surveillance and new indications, potentially restricting market expansion.

Financial Outlook and Revenue Projections

Short to Mid-Term

The nafcilin sodium market is expected to grow at a compound annual growth rate (CAGR) of approximately 3-4% over the next five years in mature markets. Factors supporting this steady growth include stable demand from hospitals and consistent use in bacterial infection management.

Long Term

Market expansion faces headwinds from rising resistance rates, which could reduce effective patient populations. Conversely, development of combination therapies and novel formulations targeting resistant strains may open new revenue streams. Industry forecasts suggest a plateau in nafcilin-specific revenues unless innovation occurs.

Pricing Trends

• Price Compression: Generic competition reduces prices by up to 20-30% over recent years.
• Reimbursement Policies: In the U.S., Medicare and private insurers' reimbursement policies influence drug affordability and sales volume.

R&D and Innovation Trends

Limited R&D efforts are currently focused on improving stability, administration convenience, and resistance profiles of existing beta-lactams. No significant pipeline candidates have nafcilin as a lead compound. The industry's emphasis shifts towards developing novel antibiotics with mechanisms to overcome resistance.

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Key Takeaways

• Nafcillin sodium remains a key IV antibiotic for penicillin-sensitive staphylococcal infections.
• The global market exceeds $2 billion, with North America dominating.
• Growth is steady but faces resistance-related challenges.
• Generic competition pressures prices and margins.
• Innovation is limited, with focus on resistance management.

FAQs

1. How does resistance affect nafcilin sodium's market?
Growing bacterial resistance leads to decreased efficacy, potentially reducing the patient pool and shifting demand towards newer agents.

2. Are there formulations of nafcilin sodium in oral form?
No, nafcilin is developed solely as an injectable formulation for hospital use, limiting the market share to inpatient settings.

3. How does the regulatory environment influence nafcilin's sales?
Regulatory agencies require ongoing safety and efficacy data. Patent expirations and generic entry further impact pricing and profitability.

4. What are the main competitors to nafcilin sodium?
Oxacillin, dicloxacillin, and nafcillin are main alternatives. Newer agents targeting resistant bacteria also pose competition.

5. Is there ongoing R&D to improve nafcilin sodium?
Most efforts focus on developing new antibiotics rather than modifying nafcilin, which has limited pipeline activity.

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References

[1] Markets and Markets. (2022). Antibiotics Market Analysis.
[2] IQVIA. (2022). Global Antibiotics Sales Data.
[3] World Health Organization. (2021). Antimicrobial resistance and the need for new antibiotics.