CLINICAL TRIALS PROFILE FOR CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

All Clinical Trials for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00124228 ↗	Albumin Administration in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis	Completed	Fondo de Investigacion Sanitaria	Phase 3	2004-11-01	Spontaneous bacterial peritonitis (SBP) present in cirrhotic patients induces severe circulatory dysfunction, which results in renal failure in up to 30% of the patients. Renal failure is an important prognostic marker, representing the major predictive factor of in-hospital mortality. Recent studies have shown that plasma volume expansion with albumin associated with cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime treatment alone. The in-hospital and three-month mortality rates, furthermore, were significantly lower in the group treated with albumin. It is not known if other bacterial infections unrelated to SBP represent a risk factor for the development of renal failure among cirrhotic patients. The researcher's group has recently performed a study to evaluate the incidence, characteristics and outcome, of renal failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results). Among a total of 106 patients, 29 (27%) presented renal failure during the course of infection. Renal failure was characterized by intense renal vasoconstriction (intrarenal resistive index of 0.83 +/- 0.09, measured by Doppler ultrasound), reduction of mean arterial pressure and an important activation of endogenous vasoconstriction systems. The three-month survival probability of patients with infection and renal failure was 34 %, much lower than that of patients with infection but not presenting renal failure (87%, p
NCT00124228 ↗	Albumin Administration in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis	Completed	Hospital Clinic of Barcelona	Phase 3	2004-11-01	Spontaneous bacterial peritonitis (SBP) present in cirrhotic patients induces severe circulatory dysfunction, which results in renal failure in up to 30% of the patients. Renal failure is an important prognostic marker, representing the major predictive factor of in-hospital mortality. Recent studies have shown that plasma volume expansion with albumin associated with cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime treatment alone. The in-hospital and three-month mortality rates, furthermore, were significantly lower in the group treated with albumin. It is not known if other bacterial infections unrelated to SBP represent a risk factor for the development of renal failure among cirrhotic patients. The researcher's group has recently performed a study to evaluate the incidence, characteristics and outcome, of renal failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results). Among a total of 106 patients, 29 (27%) presented renal failure during the course of infection. Renal failure was characterized by intense renal vasoconstriction (intrarenal resistive index of 0.83 +/- 0.09, measured by Doppler ultrasound), reduction of mean arterial pressure and an important activation of endogenous vasoconstriction systems. The three-month survival probability of patients with infection and renal failure was 34 %, much lower than that of patients with infection but not presenting renal failure (87%, p
NCT00161330 ↗	Oral vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT	Terminated	IL Sogno di Stefano	Phase 3	2000-06-01	The main objectives of the study are 1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI 2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)
NCT00161330 ↗	Oral vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT	Terminated	Regione Veneto	Phase 3	2000-06-01	The main objectives of the study are 1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI 2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)
NCT00161330 ↗	Oral vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT	Terminated	University of Padova	Phase 3	2000-06-01	The main objectives of the study are 1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI 2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)
NCT00187655 ↗	Effect of, OAT3, on the Renal Secretion of Cefotaxime	Completed	University of California, San Francisco	Phase 1	2004-01-01	In the proposed study, we plan to use a genotype to phenotype strategy to study the role of the organic anion transporter, OAT3, in drug response. More specifically we will examine the contribution of OAT3 to the renal clearance of anionic drugs such as cefotaxime by studying individuals with a non-functional (or poorly-functional) variant of OAT3.
NCT00570960 ↗	Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis	Terminated	American Association for the Study of Liver Diseases	Phase 4	2007-06-01	The core of the proposal is a prospective, randomized, double-blinded, controlled study which will compare the efficacy of dextran 70 versus human albumin in the treatment of cirrhotic patients with spontaneous bacterial peritonitis (SBP). Because dextran 70, which is FDA approved for plasma volume expansion, is significantly less expensive than human albumin, this study is designed and powered to determine if dextran 70 is equivalent in clinical efficacy when compared to albumin. Specific aims for this project are to: 1. Assess the effect of plasma volume expansion with dextran 70 on disease-specific mortality at 30 days in cirrhotic patients with spontaneous bacterial peritonitis compared to plasma volume expansion with human albumin. 2. Assess the effect of dextran 70 compared to human albumin on the prevention of renal dysfunction within 30-days of diagnosis of SBP, as measured by the calculated creatinine clearance, plasma renin activity, serum aldosterone levels, levels of brain natriuretic peptide, and further development of the hepatorenal syndrome in cirrhotic patients with spontaneous bacterial peritonitis. 3. Compare the survival to liver transplantation, treatment costs, hospitalization costs, resource utilization, and quality of life of patients with spontaneous bacterial peritonitis treated with dextran 70 and human albumin in the 30 days following diagnosis. 4. Establish a comprehensive tissue bank of blood, ascites, and urine in patients with spontaneous bacterial peritonitis for future testing and translational research. 5. Establish a clinical electronic database with web-based data entry and remote analysis capabilities linking tissue bank samples and patient outcomes related to the above clinical trials.

Clinical Trial Conditions for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

Condition Name

Condition Name for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Intervention	Trials
Spontaneous Bacterial Peritonitis	4
Urinary Tract Infections	4
Respiratory Tract Infections	3
Sepsis	3

Condition MeSH

Condition MeSH for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Intervention	Trials
Infections	9
Peritonitis	8
Infection	8
Communicable Diseases	6

Clinical Trial Locations for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Location	Trials
Egypt	8
Spain	6
France	4
Sweden	3
Vietnam	2

Trials by US State

Trials by US State for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Location	Trials
Virginia	1

Clinical Trial Progress for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	2
Phase 4	14
Phase 3	7

Clinical Trial Status

Clinical Trial Status for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	20
Recruiting	7
Unknown status	6

Clinical Trial Sponsors for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Sponsor	Trials
Assistance Publique - Hôpitaux de Paris	2
Tanta University	2
Xiangbei Welman Pharmaceutical Co., Ltd	2

Sponsor Type

Sponsor Type for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Sponsor	Trials
Other	54
Industry	3
OTHER_GOV	1

Last updated: May 23, 2026

CefoTaxime and Dextrose 2.4% in Plastic Container: Clinical Trials, Market Outlook, and Forecast

CefoTaxime and dextrose 2.4% in a plastic container is a hospital IV antibiotic-and-sugar premix presentation. Public clinical-trials coverage and detailed commercial performance data at the level of this exact product configuration are limited in open sources, which constrains high-resolution forecasting tied to this specific SKU rather than cefotaxime IV broadly.

What clinical trials exist for cefotaxime IV and do they cover cefotaxime plus dextrose premixes?

Answer: Most published interventional trials are for cefotaxime dosing regimens in infections, not for a specific “cefotaxime and dextrose 2.4% in plastic container” combination presentation. Trial public-record granularity typically does not track container formulation (plastic container) or the exact dextrose concentration when the drug substance is cefotaxime.

Clinical-trials patterns likely to be relevant to this product

Common trial endpoints for cefotaxime-containing IV regimens:

• Microbiological eradication at predefined timepoints
• Clinical response rates in bacterial infections
• Safety and tolerability (adverse events, renal function changes)
• PK/PD comparisons across dosing schedules (not container-specific)

Regimen focus vs. formulation focus

• Cefotaxime trials concentrate on spectrum (Gram-negative coverage), dosing frequency, and infection types (e.g., pneumonia, urinary tract infections, skin/soft tissue infections).
• Trials generally do not test excipient concentration (dextrose 2.4%) or container material (plastic vs glass), because those are typically CMC and stability packaging variables rather than mechanism-of-action variables.

How big is the cefotaxime IV market, and what share can a dextrose premix capture?

Answer: The relevant market is usually cefotaxime IV in hospital settings. Share for a specific premix and packaging variant (2.4% dextrose; plastic container) depends on tender requirements, substitution practices, and supply continuity rather than clinical differentiation.

Market structure considerations

Hospital IV antibiotic procurement is driven by:

• Formulary status and tender pricing
• Availability and supply reliability
• Compatibility and nursing workflow (plastic containers can be preferred)
• Therapeutic interchangeability among injectable cephalosporins when permitted

What is more measurable than the exact SKU

For forecasting, commercial analysts typically proxy:

• Total cefotaxime IV volumes (or cefotaxime sales) across major markets
• Competitive substitution rates among parenteral 3rd-generation cephalosporins
• Price erosion and margin compression dynamics due to generic competition

When does cefotaxime IV face loss of exclusivity or generic entry risk?

Answer: Most cefotaxime injectable products are long off-patent. The key risk typically is not patent-expiration competition for the API, but competition from multiple generic entrants for the exact dosage form strength and packaging configuration, plus changes in supplier qualification.

Exclusivity drivers for “packaging-and-excipient” variants

Even when the API is off-patent, lock-in can occur through:

• Reference-listed drug (RLD) status in specific label/packaging configurations
• Manufacturing authorizations and site qualification
• Product-specific listing and procurement contracts

Practical entry pathway

• If a supplier launches an ANDA for the same RLD with identical strength and route, the key market-impact variable is whether the packaged form matches clinician and procurement needs (plastic container acceptance).

What patents protect cefotaxime injections, and what parts typically matter for this specific dextrose premix?

Answer: For cefotaxime IV, patent estates usually focus on the API synthesis, early-formulation compositions, and some specific uses. For an established generic drug, the main patent relevance for a “cefotaxime and dextrose 2.4% in plastic container” product is typically:

• Process patents (manufacturing and crystallization steps)
• Formulation/stability patents (including excipient systems and container compatibility) if any remain in force
• Method-of-use patents only if a newer, protected indication exists (rare for classic cefotaxime indications)

Formulation and container compatibility

For packaged injectables, late-cycle patents often relate to:

• Stability of cefotaxime in the presence of dextrose at defined concentration
• Storage conditions and shelf-life claims
• Container interactions (leachables/extractables profiles), especially for plastic bags or infusion systems

What is the Orange Book status of cefotaxime plus dextrose 2.4% in plastic container?

Answer: Orange Book status is product- and applicant-specific. For the exact configuration, inclusion depends on whether the manufacturer lists that specific NDC strength and dosage form, and whether the product is a listed drug (RLD) or an ANDA generic that did not inherit active patents for that exact listing.

What to verify in Orange Book for SKU-level exclusivity

• RLD identity for the specified strength and dosage form
• Listed patents by US patent number
• Patent expiration dates and any pediatric exclusivity extensions
• “Orphan exclusivity” does not typically apply to standard antibiotics

(This answer cannot be completed to SKU-level accuracy from the prompt alone without the specific NDC and applicant data.)

What FDA approval pathway applies to cefotaxime and dextrose premix injectables?

Answer: In practice, cefotaxime injectables are typically approved via ANDA pathways for generics once the RLD exists, with stability and bioequivalence evidence for the formulation and packaging.

Data elements that usually govern approvals

• Chemical stability in the specified solution and container
• Sterility assurance and manufacturing controls
• Bioequivalence considerations as applicable to parenterals (often based on comparative PK or equivalence frameworks used for injectable generics)

Which companies supply cefotaxime IV, and how does the competitive landscape affect pricing?

Answer: Competitive intensity in cefotaxime IV tends to be high because the API is mature and manufacturing is widely available. Pricing in hospital channels is constrained by:

• Generic multi-sourcing
• Contract-based procurement
• Tenders where multiple equivalent cephalosporins compete

What matters commercially for this “plastic container + 2.4% dextrose” SKU

• Whether major distributors list it as a preferred interchangeable product
• Substitution rules at hospital formularies
• Lead times and cold-chain needs if any distribution requirements exist for the broader product line (usually standard storage for cefotaxime solutions, but packaging can drive constraints)

How does cefotaxime compare with other third-generation cephalosporins for hospital use and substitution risk?

Answer: As a class, cefotaxime competes with other third-generation cephalosporins in Gram-negative coverage strategies. Substitution risk depends on:

• Local antibiograms
• Formulary preference
• Coverage for resistant organisms
• Cost and availability

Substitution scenarios

• If cefotaxime is tendered, hospitals often accept equivalent cephalosporins if clinical guidelines allow.
• If cefotaxime is restricted to certain protocols (e.g., historical practice), switching risk lowers but stockouts raise urgency and substitution pressure.

What patent litigation affects cefotaxime generics and formulation/container variants?

Answer: Patent litigation for cefotaxime generics is less informative for forecasting the “cefotaxime and dextrose 2.4% in plastic container” SKU unless the litigation is tied to that exact product listing and any remaining formulation/container patents.

Most likely litigation themes in mature injectables

• ANDA patent challenges (Paragraph IV) against listed patents on the RLD
• Disputes over equivalence to listed formulation specs
• Infringement arguments focused on manufacturing and formulation steps

(SKU-level litigation mapping requires the product’s exact Orange Book listing and patent numbers, which are not provided in the prompt.)

How many patents cover cefotaxime IV products, and how strong is the estate?

Answer: For mature injectables, the number of active patents at the SKU level is typically low, with many cases resolved or expired. The “strength” question shifts from blocking patents to practical barriers:

• Manufacturing process control
• Container and excipient stability specs
• Regulatory listing and quality system readiness

What generic entry risks exist for cefotaxime plus dextrose 2.4% in plastic container?

Answer: Generic entry risk is typically more about regulatory and supply qualification than patentability:

• If multiple ANDAs already exist, incremental entry impacts are price and distribution rather than exclusivity.
• If a specific packaging configuration is less common, the first well-qualified supplier can gain short-lived procurement advantage until multi-sourcing expands.

Barriers to new entry

• Verified stability in the exact dextrose concentration
• Compatibility and extractables control for the plastic container system
• Manufacturing validation scale-up for sterile solution filling

Market projection for cefotaxime IV: what direction do volumes and pricing take?

Answer: Broad cefotaxime IV tends toward:

• Volume stability or gradual decline in mature markets as stewardship and broad-spectrum alternatives evolve
• Pricing compression driven by generic supply and contract tenders
• Cyclical demand spikes tied to infection seasonality and outbreak-related prescribing

Forecast logic that fits a mature antibiotic injectables category

• Start with total cefotaxime IV demand trend (hospital channel)
• Apply price erosion typical for mature generics
• Apply substitution among cephalosporins and stewardship shifts
• Add availability effects from supplier concentration

Timeline: key commercial and regulatory inflection points to monitor

Answer: For a mature cefotaxime IV premix SKU, the inflection points are typically:

• Any Orange Book patent status changes for the exact listing
• ANDA approvals and label changes affecting packaging acceptance
• Manufacturing site changes that affect supply continuity and allocation

What to track

• RLD changes and listing additions for the exact NDC and dosage form
• Patent expiry dates for any remaining formulation or container stability patents
• FDA labeling updates that alter dosing guidance or compatibility instructions

Key takeaways

• Clinical-trials evidence for cefotaxime exists primarily at the regimen and infection level, not specifically for “cefotaxime and dextrose 2.4% in plastic container.”
• The market outlook for this SKU is best forecast using the broader cefotaxime IV hospital category because SKU-level public data is sparse.
• Exclusivity and “loss of exclusivity” are likely not the binding issue; generic supply presence and packaging acceptance are the main drivers.
• Patent relevance, if any, is likely tied to formulation/container stability or manufacturing process rather than core API composition, given cefotaxime’s maturity.

FAQs

1) Is cefotaxime and dextrose 2.4% in plastic container considered therapeutically equivalent to cefotaxime alone?
For FDA substitution, equivalence depends on the exact approved dosage form and label; clinically, dextrose is an excipient and does not change cefotaxime’s antimicrobial activity, but dosing volume and solution stability can differ by product.

2) Does plastic container packaging affect cefotaxime stability or safety?
Container materials can affect stability and extractables/leachables profiles; approvals typically rely on stability and compatibility studies specific to the packaging system.

3) Are clinical outcomes for cefotaxime influenced by the dextrose concentration in the infusion solution?
Usually not for antimicrobial efficacy, because dextrose acts as a carrier excipient; however, total infusion fluid volume and patient-specific carbohydrate considerations can matter.

4) What is the most common FDA pathway for cefotaxime IV solutions?
Mature cephalosporin injectables are typically approved as generics via ANDA against an RLD, with formulation and stability evidence tied to the approved dosage form.

5) Will generic entry for cefotaxime IV reduce hospital prices immediately?
Prices often compress after ANDA approvals and contract renegotiations, but the timing depends on tender cycles, multi-sourcing, and distributor availability.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (accessed 2026-05-23).
2. ClinicalTrials.gov. Search results for cefotaxime (accessed 2026-05-23).