CLOXACILLIN SODIUM Drug Patent Profile

When do Cloxacillin Sodium patents expire, and when can generic versions of Cloxacillin Sodium launch?

Cloxacillin Sodium is a drug marketed by Apothecon and Teva and is included in four NDAs.

The generic ingredient in CLOXACILLIN SODIUM is cloxacillin sodium. There are twenty-three drug master file entries for this compound. Additional details are available on the cloxacillin sodium profile page.

Summary for CLOXACILLIN SODIUM

US Patents:	0
Applicants:	2
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	1
Patent Applications:	1,354
DailyMed Link:	CLOXACILLIN SODIUM at DailyMed

Recent Clinical Trials for CLOXACILLIN 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 CLOXACILLIN SODIUM clinical trials

Medical Subject Heading (MeSH) Categories for CLOXACILLIN SODIUM

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for CLOXACILLIN 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

US Patents and Regulatory Information for CLOXACILLIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apothecon	CLOXACILLIN SODIUM	cloxacillin sodium	CAPSULE;ORAL	061452-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Teva	CLOXACILLIN SODIUM	cloxacillin sodium	CAPSULE;ORAL	062240-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Apothecon	CLOXACILLIN SODIUM	cloxacillin sodium	CAPSULE;ORAL	061452-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Teva	CLOXACILLIN SODIUM	cloxacillin sodium	CAPSULE;ORAL	062240-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Teva	CLOXACILLIN SODIUM	cloxacillin sodium	FOR SOLUTION;ORAL	062978-001	Apr 6, 1989		DISCN	No	No
Teva	CLOXACILLIN SODIUM	cloxacillin sodium	FOR SOLUTION;ORAL	062268-001	Approved Prior to Jan 1, 1982		DISCN	No	No

CLOXACILLIN SODIUM Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Market Dynamics for Cloxacillin Sodium?

Cloxacillin sodium is an antibiotic targeting penicillinase-producing bacteria, notably Staphylococcus aureus. Currently, it occupies a niche within the broader beta-lactam antibiotic market, primarily used in hospital settings and in formulations for complicated skin infections.

Market drivers include increasing bacterial resistance to first-line antibiotics, promoting the need for alternative agents like cloxacillin. The rise in skin and soft tissue infections caused by methicillin-sensitive Staphylococcus aureus (MSSA) supports steady demand, especially in regions with high outpatient and inpatient treatment rates.

Key challenges include:

• Limited Spectrum: Ineffective against methicillin-resistant strains.
• Competition: From other beta-lactams, such as dicloxacillin, nafcillin, and cefazolin.
• Generic Availability: Widely available as a generic, reducing price premiums.
• Regulatory Challenges: Differences in approval and guideline recommendations across markets.

The market size remains relatively limited, with estimates suggesting global sales in the low hundreds of millions USD annually, dominated by North America and Europe, where clinical guidelines recommend its use for MSSA infections.

How Does the Financial Trajectory Look for Cloxacillin Sodium?

Financial forecasts for cloxacillin sodium depend on several factors:

• Market Penetration: Its use remains largely confined to hospitals where it is prescribed for specific infections.
• Pricing: Being a generic drug, prices are low, averaging approximately $0.50–$2 per dose, leading to modest revenue generation.
• Supply Chain: Several manufacturers operate globally, balancing supply and competition, which influences pricing.
• Regulatory Status: Approved in most major markets but with variable indications.

Based on current market conditions, combined with patent expirations, revenues are projected to plateau or decline gradually. The drug’s sales are expected to remain stable but limited unless new formulations, delivery methods, or combination therapies are introduced.

Emerging trends include:

• Growth in biosimilar formulations to lower costs.
• Expansion into emerging markets, where infection rates are high but access to newer agents remains limited.

Financial projections estimate:

• Global sales to stay within $100–$200 million annually over the next five years.
• Margins remain thin due to high generic competition but could improve with supply chain optimization.

How Does Cloxacillin Sodium Compete With Alternatives?

Within its segment, cloxacillin sodium faces competition from:

• Dicloxacillin (oral and IV formulations)
• Nafcillin (primarily US market)
• Cefazolin (alternative for MSSA infections)

While these drugs have similar efficacy, factors like drug availability, clinician familiarity, and local resistance patterns influence prescribing habits. The low cost and established safety profile favor cloxacillin sodium, but pathogen resistance trends could restrict use.

What Are the Regulatory and Developmental Considerations?

No major recent indications or formulation updates have emerged. Regulatory bodies like the FDA, EMA, and others have approved its use for specific bacterial infections but have not prioritized expanding its indications.

Developers exploring new formulations or combination therapies face regulatory uncertainties, as evidence of clinical superiority over existing agents remains necessary for market expansion.

Key Takeaways

• Cloxacillin sodium operates in a niche within the antibiotic market targeting MSSA bacteria.
• Market growth is constrained by limited spectrum, high generic competition, and regional prescribing habits.
• Annual global revenues likely stay within $100–$200 million.
• Market expansion opportunities are limited without new formulations or indications.
• Competition from other beta-lactams, especially cefazolin, influences market adoption.

FAQs

1. Can the market for cloxacillin sodium expand to address resistant bacteria?
No, it does not have activity against MRSA, limiting its role in combating resistant bacteria beyond MSSA.

2. Are there any new formulations or delivery methods under development?
Currently no significant pipeline exists for novel formulations; focus remains on existing generics and formulations.

3. How do regional prescribing habits affect its market?
In regions where guidelines favor other agents like cefazolin or nafcillin, cloxacillin sodium's use declines.

4. What factors could improve the drug's market outlook?
Introduction of cost-effective biosimilars or combination therapies targeting resistant strains could expand its use.

5. What is the outlook for generic competition impacting prices?
The presence of multiple manufacturers keeps prices low, constraining profit margins and overall revenues.

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References

[1] IQVIA, "Global Antibiotics Market Analysis," 2022.
[2] EvaluatePharma, "Topical and injectable antibiotics revenue estimates," 2022.
[3] WHO, "Antimicrobial Resistance Global Report," 2021.
[4] U.S. FDA, "Drug Approvals and Regulatory Status," 2023.