CLOXACILLIN SODIUM Drug Patent Profile

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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 is one drug master file entry 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:	1,406
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

Cloxacillin Sodium Market Dynamics, Patent Status, Competitive Landscape, and Financial Outlook

Last updated: September 3, 2026

Cloxacillin sodium is a mature, off-patent antistaphylococcal penicillin used mainly for susceptible methicillin-sensitive Staphylococcus aureus infections. Its commercial profile is defined by low prices, fragmented generic supply, limited innovation, and regional rather than global demand. No meaningful standalone revenue series is publicly reported for cloxacillin sodium, and the product does not have a current branded patent-driven market in the United States.

What is the current market position of cloxacillin sodium?

Cloxacillin sodium is a narrow-spectrum beta-lactam antibiotic in the penicillinase-resistant penicillin class. The active ingredient is classified under ATC code J01CF02. It is used in oral and injectable products, although product availability varies sharply by country.[1]

The main clinical target is susceptible methicillin-sensitive Staphylococcus aureus, including skin, soft-tissue, bone, joint, and other serious infections. It has no useful activity against methicillin-resistant Staphylococcus aureus, most gram-negative pathogens, or organisms producing resistance mechanisms that defeat the drug.

Market attribute	Cloxacillin sodium profile
Therapeutic class	Penicillinase-resistant penicillin
ATC code	J01CF02
Primary target	Methicillin-sensitive S. aureus
Dosage forms	Capsules, oral suspension in some markets, injectable sodium salt
Regulatory status	Mature generic product; availability is jurisdiction-specific
U.S. commercial status	Limited or absent current branded-market presence
Patent status	Originator and core composition protection expired
Biosimilar exposure	None; this is a small-molecule antibiotic
Pricing	Low-cost generic, tender- and volume-driven
Commercial growth driver	Unit demand and supply access, not price expansion

The market is concentrated in countries where cloxacillin remains included in hospital formularies, national treatment protocols, or essential-medicines procurement. Demand is weaker in markets that have shifted toward flucloxacillin, dicloxacillin, cefazolin, or other alternatives.

How large is the cloxacillin sodium market?

No authoritative public source reports global cloxacillin sodium sales as a standalone product category. Public company filings generally aggregate it within broader antibiotic, injectable, or hospital-product portfolios. Commercial market reports that estimate the product separately are often based on proprietary datasets and should not be treated as audited financial figures.

The most defensible market conclusion is that cloxacillin sodium is a small generic pharmaceutical segment with low average selling prices and limited manufacturer-level revenue concentration. Its financial value is higher in aggregate hospital and anti-infective portfolios than as an individual molecule.

Revenue characteristics

Cloxacillin sodium revenue has four structural characteristics:

1. Low price per treatment course compared with patented antibiotics and newer anti-infective agents.
2. High dependence on institutional purchasing and public tenders.
3. Limited ability to raise prices without losing formulary or procurement share.
4. Volatile revenue when suppliers exit, manufacturing capacity changes, or shortages occur.

The product can generate useful incremental revenue for manufacturers with existing sterile injectable facilities, established hospital distribution, or regional procurement contracts. It is unlikely to support a high-margin standalone commercial strategy.

What is the financial trajectory for cloxacillin sodium?

The long-term trajectory is mature to declining in developed markets, with selective stability or growth in emerging markets where access to low-cost antistaphylococcal therapy remains important.

Period	Financial trajectory	Main drivers
Historical originator period	High relative margin	Limited competition and early clinical adoption
Mature generic period	Sharp price compression	Multiple suppliers and expired exclusivity
Current market	Low-margin, fragmented	Hospital tenders, generic substitution, regional demand
Medium term	Flat to declining in many markets	Therapeutic substitution and stewardship
Upside case	Stable niche demand	Essential-medicine procurement and supply shortages
Downside case	Faster erosion	Supplier withdrawal, clinical replacement, weak reimbursement

Growth in units does not necessarily translate into revenue growth. Public-sector purchasing can increase volumes while reducing net prices. Injectable products may provide better economics than oral capsules because sterile manufacturing creates a higher technical barrier, but that barrier also increases quality, validation, and supply-chain costs.

What factors could improve revenue?

Revenue could improve where:

• national procurement programs prioritize narrow-spectrum antibiotics;
• local manufacturers receive regulatory or tender advantages;
• competing products experience shortages;
• hospitals require injectable anti-staphylococcal alternatives;
• manufacturers combine cloxacillin with broader hospital portfolios.

These factors generally improve volume utilization rather than create durable pricing power.

What patents protect cloxacillin sodium?

No meaningful active patent estate is expected to protect the cloxacillin sodium active ingredient in major markets. Cloxacillin was developed and commercialized decades ago, placing its core composition, synthesis, and basic pharmaceutical-use patents well beyond ordinary patent terms.

Patent categories

Patent category	Current commercial relevance
Active ingredient composition	Expired
Basic manufacturing process	Expired or commercially nonexclusive
Conventional capsule formulations	Expired
Conventional injectable formulations	Expired or unlikely to create broad exclusion
Method-of-use claims for susceptible infections	Generally expired or difficult to enforce broadly
New delivery system	Potentially patentable only if technically novel
Combination therapy	Potentially patentable, but not intrinsic to cloxacillin sodium

The absence of a core patent estate does not eliminate all intellectual-property barriers. A company could seek protection for a novel depot formulation, sustained-release system, combination product, manufacturing improvement, or packaging configuration. Those rights would protect the specific improvement, not cloxacillin sodium itself.

When does cloxacillin sodium lose exclusivity?

Cloxacillin sodium lost meaningful market exclusivity decades ago. The relevant commercial event is not a future patent expiration but the continuing erosion of residual demand among generic suppliers.

The product’s competitive exclusivity is also distinct from FDA regulatory exclusivity. There is no current indication of a commercially significant U.S. new-drug exclusivity period for conventional cloxacillin sodium products. Any abbreviated new drug application, where applicable, would compete against an established active ingredient rather than enter a protected branded market.

What is the FDA and Orange Book status of cloxacillin sodium?

Cloxacillin sodium has no current U.S. patent-protected branded position comparable to products listed with active patent claims in the FDA Orange Book. The FDA Orange Book is the relevant source for approved drug products, reference listed drugs, and listed patent information.[2]

U.S. availability appears limited compared with other penicillins. Products listed in drug-label repositories or historical FDA records should not automatically be treated as commercially active products. DailyMed labeling can remain available even when distribution is limited, discontinued, or restricted to a particular supplier.[3]

The principal U.S. regulatory risks are therefore practical rather than exclusivity-based:

• whether a current manufacturer has an active, saleable product;
• whether the product is listed as available in the relevant dosage form;
• whether sterile injectable supply is reliable;
• whether the product has adequate hospital and wholesaler distribution;
• whether FDA manufacturing and quality requirements can be met economically.

Are there Paragraph IV challenges involving cloxacillin sodium?

A commercially important Paragraph IV campaign is unlikely. Paragraph IV litigation is typically relevant when a generic applicant challenges patents listed by an innovator in the Orange Book. Cloxacillin sodium lacks the type of active branded patent estate that would normally generate substantial Paragraph IV litigation.

A generic applicant could theoretically file a Paragraph IV certification if an Orange Book-listed patent existed for a particular reference product. That legal possibility does not establish a meaningful litigation risk. Publicly visible market conditions indicate that cloxacillin sodium is a mature generic market rather than an active branded-generic patent battleground.

What formulations are protected by cloxacillin sodium patents?

Conventional cloxacillin sodium formulations, including standard capsules and injectable preparations, are not expected to have commercially significant surviving patent protection.

Potentially protectable formulation areas include:

• controlled-release oral systems;
• improved stability formulations;
• ready-to-use injectable solutions;
• reduced-reconstitution products;
• combination products;
• pediatric dosage forms with improved palatability;
• specialized packaging that extends shelf life.

These innovations would face a difficult commercial test. Cloxacillin’s low price constrains the premium that hospitals, governments, and patients may accept for an improved formulation. A formulation patent could have legal value while producing limited economic value.

What manufacturing and intellectual-property barriers affect supply?

The principal manufacturing barrier is sterile production for injectable cloxacillin sodium. Injectable products require validated aseptic processing, appropriate container-closure systems, sterility testing, stability data, and reliable active-pharmaceutical-ingredient supply.

The commercial barriers include:

• low unit prices;
• batch-scale inefficiency;
• limited procurement margins;
• quality-system costs;
• dependence on hospital tenders;
• raw-material availability;
• regulatory requirements for sterile facilities;
• low incentives to maintain multiple suppliers.

Oral capsules are easier to manufacture and distribute but face stronger price competition. Injectable products have fewer capable suppliers and may experience more pronounced regional supply volatility.

Which companies compete in the cloxacillin sodium market?

Competition is fragmented and jurisdiction-specific. Generic antibiotic companies, hospital-product manufacturers, local pharmaceutical firms, and contract manufacturers may all participate. A supplier’s competitive position depends less on brand recognition than on regulatory registrations, tender eligibility, manufacturing reliability, and access to hospital channels.

The relevant competitive set includes:

• cloxacillin sodium generic manufacturers;
• flucloxacillin suppliers;
• dicloxacillin suppliers;
• cefazolin manufacturers;
• other beta-lactam hospital-antibiotic suppliers;
• local manufacturers with government procurement advantages.

Flucloxacillin and dicloxacillin are particularly important comparators because they occupy similar antistaphylococcal treatment niches in several markets. Cefazolin can displace cloxacillin in hospital use because of dosing convenience, institutional familiarity, and parenteral administration.

How does cloxacillin sodium compare with flucloxacillin and dicloxacillin?

Factor	Cloxacillin sodium	Flucloxacillin	Dicloxacillin
Main use	MSSA infections	MSSA infections	MSSA infections
Commercial maturity	Very mature generic	Mature generic	Mature generic
Common availability	Regional	Stronger in some European and Commonwealth markets	Stronger in some North American markets
Patent protection	None of practical significance	None of practical significance for core drug
Pricing power	Low	Low	Low
Key advantage	Established low-cost option	Broad regional formulary adoption	Oral dosing and regional familiarity
Main weakness	Limited availability and substitution	Adverse-effect and adherence considerations	Narrow market and generic competition

Clinical selection is driven by local guidelines, susceptibility patterns, dosing, tolerability, procurement price, and product availability. These factors make market share highly regional.

Is there biosimilar or generic entry risk for cloxacillin sodium?

Biosimilar risk does not apply because cloxacillin sodium is a chemically synthesized small molecule, not a biologic. Generic entry risk is already realized. The market has operated under generic competition for decades.

Future entry may still occur in countries where:

• no local manufacturer is registered;
• procurement demand is underserved;
• an injectable presentation is unavailable;
• a supplier exits the market;
• a new regulatory pathway reduces registration costs.

New entrants would face low barriers for conventional oral products and higher barriers for sterile injectables. Entry would likely increase supply resilience but further compress prices.

What patent litigation or settlement agreements affect cloxacillin sodium?

No major current U.S. patent litigation or settlement structure is associated with conventional cloxacillin sodium. The absence of litigation is consistent with the product’s age, generic status, and lack of a valuable active patent estate.

Any future dispute would more likely involve:

• manufacturing quality;
• trademark or product naming;
• regulatory compliance;
• supply contracts;
• procurement awards;
• formulation-specific patents;
• infringement claims covering a new delivery technology.

What is the geographic coverage of the cloxacillin sodium market?

Cloxacillin sodium has greater commercial relevance in regions where antistaphylococcal penicillins remain embedded in national formularies and hospital treatment protocols. Availability is uneven. A product may be registered in a country without being consistently stocked, reimbursed, or supplied through public hospitals.

Geographic performance depends on:

• national essential-medicines lists;
• local antimicrobial guidelines;
• public procurement systems;
• domestic manufacturing policy;
• antibiotic stewardship programs;
• incidence of susceptible staphylococcal infections;
• availability of flucloxacillin, dicloxacillin, and cefazolin.

The global market should therefore be analyzed country by country rather than through a single worldwide revenue estimate.

What is the commercial outlook for cloxacillin sodium?

The base case is a low-growth or declining market in high-income countries and a stable niche market in selected emerging economies. The product is unlikely to produce material margin expansion without a differentiated formulation, exclusive procurement position, or supply advantage.

The most attractive commercial strategy is portfolio-based. A manufacturer can use cloxacillin sodium to support a broader hospital anti-infective offering, improve tender coverage, or monetize underutilized sterile capacity. A standalone investment thesis based on price growth, patent protection, or branded conversion is weak.

Key Takeaways

• Cloxacillin sodium is a mature, off-patent antistaphylococcal antibiotic.
• No meaningful active composition or core-use patent estate is expected.
• Paragraph IV litigation and branded-generic patent risk are limited.
• No biosimilar risk exists; generic competition is already established.
• Standalone global revenue is not publicly disclosed.
• Financial performance is driven by volume, tenders, supply reliability, and geographic registration.
• Injectable products have higher manufacturing barriers but also higher quality and capacity costs.
• Flucloxacillin, dicloxacillin, and cefazolin are the main commercial substitutes.
• The medium-term outlook is stable to declining, with selective regional demand.
• The strongest business case is as part of a broader hospital or generic-antibiotic portfolio.

FAQs About Cloxacillin Sodium Market and Exclusivity

Is cloxacillin sodium still commercially available?

Availability is jurisdiction-specific. It remains marketed in selected countries, but distribution is limited or inconsistent in some developed markets.

Can a company obtain a new patent on cloxacillin sodium?

A patent cannot ordinarily be obtained for the old active ingredient itself. A company may seek protection for a genuinely novel formulation, manufacturing process, combination, or delivery system.

Does cloxacillin sodium have an Orange Book reference listed drug?

The U.S. Orange Book does not indicate a current patent-protected branded market comparable to newer drugs. Historical or limited product listings should be distinguished from active commercial distribution.

Is cloxacillin sodium more profitable in injectable or oral form?

Injectable products may offer better unit economics because sterile manufacturing limits competition. They also carry higher manufacturing, quality, and supply-chain costs.

Could cloxacillin sodium sales increase because of antibiotic shortages?

Yes. Temporary shortages of alternative antistaphylococcal antibiotics can increase demand, but shortage-driven gains are usually episodic and do not create durable pricing power.

References

1. World Health Organization Collaborating Centre for Drug Statistics Methodology. (2024). ATC/DDD index: J01CF02 cloxacillin. https://www.whocc.no/atc_ddd_index/
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
3. U.S. National Library of Medicine. (2024). DailyMed: Current medication information. https://dailymed.nlm.nih.gov/dailymed/
4. World Health Organization. (2023). WHO model list of essential medicines, 23rd list. https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02
5. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/