When will the CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER patents expire, and when will CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER go generic?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun	CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER	cefotaxime sodium	INJECTABLE;INJECTION	050792-002	Jul 29, 2004		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: August 11, 2026

Cefotaxime and Dextrose 3.9% in a plastic container is a mature, generic injectable antibiotic product. Its commercial value is driven by hospital procurement, manufacturing reliability, sterile-injectable capacity, and premixed-delivery convenience rather than by patent exclusivity. The financial trajectory is likely low-growth to declining in established markets, with periodic price increases or supply-driven revenue spikes when competing injectable cephalosporins face shortages.

What is Cefotaxime and Dextrose 3.9% in a Plastic Container?

The product combines cefotaxime sodium, a third-generation cephalosporin, with a dextrose-containing intravenous diluent in a flexible plastic container. Cefotaxime is used for serious bacterial infections, including lower respiratory tract infections, urinary tract infections, intra-abdominal infections, septicemia, meningitis, skin and soft-tissue infections, and gynecologic infections. The FDA-approved labeling describes intravenous and intramuscular administration of cefotaxime sodium and dosing based on infection severity, patient age, renal function, and organism susceptibility (DailyMed, n.d.).

The 3.9% dextrose component is primarily a delivery and formulation attribute. It does not provide a separate therapeutic exclusivity position. The product competes with:

Cefotaxime injection supplied as a vial requiring reconstitution
Ceftriaxone injection
Ceftazidime injection
Cefepime injection
Ampicillin-sulbactam
Piperacillin-tazobactam
Other premixed or pharmacy-compounded intravenous antibiotics

The plastic container can reduce pharmacy preparation time, needle manipulation, and compounding workload. Those benefits matter most in hospitals with centralized pharmacy operations, high antibiotic throughput, or limited sterile-compounding capacity.

What is the FDA regulatory status of cefotaxime and dextrose injection?

Cefotaxime is an established generic active ingredient with no meaningful new-molecule exclusivity remaining in the United States. The product’s regulatory position depends on the specific application holder, strength, container configuration, and FDA application or NDC number.

The FDA’s Orange Book identifies approved drug products and associated patent or exclusivity information. Mature cefotaxime products generally do not carry remaining new chemical entity exclusivity, pediatric exclusivity, or orphan exclusivity. A premixed cefotaxime-dextrose product would need to be evaluated under its specific application record rather than by active ingredient alone (U.S. Food and Drug Administration, 2024a).

DailyMed provides labeling for cefotaxime sodium products, including warnings concerning beta-lactam hypersensitivity, Clostridioides difficile-associated diarrhea, renal impairment, and incompatibility or stability considerations. The product label remains the controlling source for approved concentration, administration method, storage, and container instructions (DailyMed, n.d.).

What patents protect cefotaxime and dextrose 3.9% in a plastic container?

No active-ingredient patent is expected to protect cefotaxime in the United States. Cefotaxime was discovered and commercialized decades ago, and its core composition-of-matter protection has expired.

Potential intellectual-property protection may relate to:

A specific premixed concentration
Container construction
Port, overwrap, or closure design
Oxygen or moisture barrier technology
Sterilization method
Cefotaxime stability in dextrose solution
Manufacturing and filling processes
Extended storage or ready-to-use presentation

These rights generally have narrower commercial scope than a drug-substance patent. A competing manufacturer may avoid infringement by changing the container, concentration, formulation pH, overwrap, filling sequence, or sterilization process.

How strong is the patent estate?

The patent estate is weak at the active-ingredient level and potentially moderate at the product and manufacturing level. The principal commercial barrier is not patent exclusivity. It is the technical and regulatory difficulty of producing a stable, sterile, ready-to-use injectable product at acceptable cost.

A patent review should distinguish:

Protection category	Expected relevance
Cefotaxime composition patent	None or expired
New chemical entity exclusivity	Expired
Premixed dextrose formulation	Potentially narrow
Plastic-container design	Potentially narrow
Sterile manufacturing process	Potentially relevant
Stability and shelf-life technology	Potentially relevant
Method-of-use patent	Low relevance for established indications
Regulatory exclusivity	Generally expired

When does cefotaxime lose exclusivity?

Cefotaxime lost primary pharmaceutical exclusivity many years ago. The product is commercially exposed to generic competition and does not depend on a remaining branded exclusivity period.

The relevant timeline is:

Event	Commercial effect
Original cefotaxime approval	Established the reference product
Expiration of composition protection	Opened the market to generic manufacturers
Generic injectable approvals	Increased price and supply competition
Premixed-container launches	Added convenience-based differentiation
Current market	Procurement-led generic competition

Because the product is mature, future revenue does not depend on an exclusivity cliff. Revenue changes instead reflect contract wins, hospital formulary decisions, manufacturing interruptions, shortages, and competitor exits.

Are there Paragraph IV challenges for cefotaxime and dextrose injection?

Paragraph IV litigation is unlikely to be a major current market factor for this product. Paragraph IV challenges are most valuable when an applicant seeks approval before the expiry of a relevant listed patent. A mature cefotaxime premix product is more likely to face ordinary abbreviated new drug application competition, manufacturing transfers, or product discontinuation than high-value patent litigation.

The commercial risk from a new generic would therefore be immediate price competition rather than a contested early-entry event. If an Orange Book-listed formulation or container patent exists for a particular application, the applicant’s certification and litigation position would need to be assessed at the application level. The active ingredient alone does not establish a Paragraph IV barrier.

What formulation patents protect the plastic-container presentation?

Formulation protection, where present, would focus on stability and compatibility. Cefotaxime can be sensitive to solution conditions, storage temperature, concentration, and time. A ready-to-use dextrose presentation must maintain potency and control degradation throughout its labeled shelf life.

Relevant technical issues include:

Cefotaxime degradation in aqueous solution
pH control
Interaction between drug solution and plastic surfaces
Extractables and leachables
Container permeability
Sterility maintenance
Terminal sterilization or aseptic filling
Freeze-thaw performance
Overwrap requirements
Compatibility with intravenous administration systems

A container or process patent can create a manufacturing barrier without creating meaningful market exclusivity. Competitors may use a different polymer, bag geometry, overwrap, filling process, or concentration.

What drives demand for cefotaxime and dextrose injection?

Demand is concentrated in institutional healthcare. Key purchasing channels include acute-care hospitals, government facilities, integrated delivery networks, group purchasing organizations, outpatient infusion centers, and international public-health procurement programs.

Demand drivers include:

Hospital admissions requiring parenteral antibiotics.
Local antimicrobial-resistance patterns.
Availability of ceftriaxone and cefepime.
Hospital formulary preferences.
Pharmacy labor costs.
Sterile-compounding capacity.
Product shortages affecting substitute antibiotics.
Use in pediatric, obstetric, and critical-care settings.
Public-sector tenders in price-sensitive markets.
Supplier reliability and contract performance.

The product’s premixed format can command a modest operational premium over a vial if it reduces preparation time and medication-use risk. That premium is limited because hospitals frequently select antibiotics through competitive tenders and multi-product contracts.

How does cefotaxime compare with ceftriaxone and cefepime?

Ceftriaxone is the strongest broad commercial substitute in many markets because of once-daily dosing, broad clinical use, and extensive generic availability. Cefepime competes in settings requiring broader activity against resistant gram-negative organisms, including Pseudomonas aeruginosa. Cefotaxime remains relevant where local guidelines, neonatal practice, formulary history, or procurement pricing support its use.

Product	Main commercial advantage	Main limitation
Cefotaxime	Established clinical use and broad generic supply	More frequent dosing than ceftriaxone
Ceftriaxone	Once-daily administration and strong generic penetration	Formulary restrictions in some settings
Cefepime	Broader antipseudomonal positioning	Higher cost and stewardship controls
Ceftazidime	Antipseudomonal activity	Narrower positioning and competing agents
Piperacillin-tazobactam	Broad gram-positive and gram-negative coverage	Higher formulation and procurement cost

Cefotaxime and ceftriaxone are the closest commercial comparators. A cefotaxime premix may compete on availability and workflow efficiency rather than clinical superiority.

What is the financial trajectory for the product?

Public companies generally do not report revenue for an individual mature injectable SKU such as cefotaxime and dextrose 3.9% in a plastic container. Sales are commonly aggregated into hospital injectable, generic sterile, or international pharmaceutical segments. As a result, product-level revenue, gross margin, and unit volume are not reliably available from public filings.

The likely trajectory is:

Period	Expected financial pattern
Near term	Stable or volatile revenue tied to contracts and supply
Medium term	Price pressure from generic competitors
Shortage periods	Temporary volume and price increases
Long term	Gradual decline unless supported by tenders or supply exits

Revenue can rise despite declining long-term demand when competitors experience manufacturing failures or regulatory remediation. Injectable products are vulnerable to supply disruption because sterile facilities are expensive to build, validate, and maintain. A supplier with an approved plastic-container presentation may therefore gain temporary share during shortages.

Margin performance depends on:

API cefotaxime cost
Dextrose and container costs
Sterile filling utilization
Quality-control expenses
Scrap and batch-failure rates
Freight and cold-chain requirements, if applicable
Contract pricing
Hospital chargeback and rebate arrangements
Regulatory maintenance costs
Manufacturing-site concentration

The premixed format may produce higher gross profit per administration than a vial, but it also carries higher packaging, stability, and quality-control costs.

Which companies are challenging the product commercially?

The competitive field includes generic sterile-injectable manufacturers, contract manufacturers, hospital-focused pharmaceutical suppliers, and multinational companies with broad anti-infective portfolios. The relevant competitive threat is not usually a single branded challenger. It is a group of suppliers competing for hospital contracts and maintaining overlapping cefotaxime, ceftriaxone, and other cephalosporin capacity.

Competition is strongest where:

Multiple approved suppliers serve the same market.
Hospitals use annual or quarterly tenders.
Ceftriaxone is available at a lower delivered cost.
Vial reconstitution is operationally acceptable.
The premix carries no reimbursement premium.
Government procurement treats products as therapeutically substitutable.

The product can retain a niche position if it has reliable supply, favorable shelf life, validated compatibility, and established hospital use.

What generic launch risks exist?

Generic launch risk is high in price but moderate in technical execution. A new entrant does not need to overcome active-ingredient patent barriers, but it must establish an approved sterile manufacturing process and demonstrate product quality.

Key launch risks include:

Difficulty matching formulation stability
Container-closure integrity failures
Visible or subvisible particulate contamination
Shorter shelf life than the incumbent
Inadequate supply of validated plastic containers
FDA inspection findings
Batch-release delays
Hospital reluctance to switch premixed products
Failure to secure a group-purchasing contract
Low margins after tender discounts

The most credible new entrant is an established sterile-injectable manufacturer with an existing cefotaxime application, validated filling lines, and hospital distribution infrastructure.

What manufacturing and IP barriers affect the market?

Manufacturing barriers are more important than patent barriers. A plastic-container injectable requires control over formulation, compounding, filling, sterilization or aseptic processing, container closure, and stability testing.

The highest-value operational assets are:

Approved sterile manufacturing capacity
Reliable container supply
Validated cefotaxime stability data
Low batch-failure rates
Regulatory history without major observations
Hospital distribution contracts
Ability to maintain supply during shortages

A company with a differentiated container or longer shelf life may defend share through operational performance even without strong patent protection.

What litigation and settlement agreements affect cefotaxime?

No major current patent-litigation or settlement-driven market event is associated with the mature cefotaxime active ingredient based on the general regulatory profile of the product. Any relevant litigation would likely concern a specific formulation, container, manufacturing process, supply agreement, product liability claim, or regulatory action rather than the core cefotaxime molecule.

Settlement agreements are unlikely to create a meaningful delayed generic-entry structure for the established active ingredient. Commercial agreements are more likely to involve hospital contracts, distribution rights, private-label supply, or government tenders.

Is there biosimilar risk for cefotaxime?

There is no biosimilar risk. Cefotaxime is a chemically synthesized small-molecule antibiotic, not a biologic. Competitive products are regulated as generic drugs or equivalent pharmaceutical products, depending on jurisdiction.

The relevant competitive risk is generic substitution and therapeutic substitution by other beta-lactam antibiotics.

What is the geographic market opportunity?

North America and Western Europe are mature, price-sensitive markets. Growth opportunities are more likely in emerging markets, public-sector tenders, and regions where injectable antibiotic access is expanding.

Geographic performance depends on:

Local registration requirements
Hospital procurement systems
Antimicrobial stewardship policies
Local resistance patterns
Domestic manufacturing preferences
Currency and tender pricing
Import restrictions
Availability of sterile injectable facilities

In lower-income markets, vial presentations may remain more economical than premixed plastic containers. In higher-income hospital systems, premixed products can benefit from pharmacy-efficiency and medication-safety considerations.

Key Takeaways

Cefotaxime and Dextrose 3.9% in a plastic container is a mature generic injectable product.
Core cefotaxime patent protection and regulatory exclusivity have expired.
The commercial moat is based on sterile manufacturing, supply reliability, formulation stability, and hospital contracts.
The plastic-container presentation provides workflow convenience but limited standalone pricing power.
Ceftriaxone is the closest major substitute and creates persistent pricing pressure.
Paragraph IV litigation and biosimilar risk are not central to the product’s current outlook.
Revenue is likely stable to declining over the long term, with temporary increases during shortages or contract wins.
Public filings generally do not disclose product-level sales or profitability.
The main risks are generic price erosion, hospital tender losses, manufacturing interruptions, and substitution by ceftriaxone or cefepime.
The strongest commercial position belongs to a supplier with validated premix technology, dependable sterile capacity, and broad hospital distribution.

FAQs

Is cefotaxime and dextrose 3.9% still commercially viable?

Yes, but primarily as a hospital and institutional product. Viability depends on procurement contracts, supply reliability, and the value hospitals assign to ready-to-use administration.

Does the plastic container create patent exclusivity?

Usually not by itself. A container design or associated manufacturing process may be patented, but such rights are narrower than composition-of-matter protection and may be designed around.

Can a generic manufacturer launch cefotaxime premix without a Paragraph IV dispute?

Potentially. If no relevant unexpired Orange Book-listed patent applies to the target presentation, the applicant would not face the same early-entry litigation risk associated with a patented branded product.

Why might hospitals buy a premixed cefotaxime product instead of a vial?

The premix can reduce pharmacy preparation, handling steps, compounding workload, and medication-use complexity. The benefit must offset the product’s potentially higher procurement cost.

What is the largest long-term threat to cefotaxime premix sales?

Therapeutic substitution, especially by ceftriaxone, is the largest structural threat. Price competition from other generic suppliers and loss of hospital contracts are the main direct commercial risks.

References

DailyMed. (n.d.). Cefotaxime sodium injection prescribing information. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

U.S. Food and Drug Administration. (2024a). 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

U.S. Food and Drug Administration. (2024b). National Drug Code directory. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory

U.S. Food and Drug Administration. (2024c). Drug shortages. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages-index-trending-viewer f

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	40
DailyMed Link:	CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER at DailyMed

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