CLINICAL TRIALS PROFILE FOR LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000778 ↗	A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To evaluate the methodology for rapidly determining the early bactericidal activity (EBA), tolerance, and pharmacokinetics of isoniazid and levofloxacin in the treatment of pulmonary tuberculosis (TB). Traditionally, in trials for treatment of TB, a new drug is administered in combination with two or more other antituberculous agents of known effectiveness over a long period of time. In this setting, it is difficult to determine the effect of any single drug or dose level. Development of new agents for the treatment of TB may be accelerated by a methodology in which a new agent could be evaluated for activity by administering it as a single agent over a short time period. This study utilizes a method to measure the amount of bacteria present each day in the lungs.
NCT00000796 ↗	A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDR	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per 9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain. Among TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion.
NCT00001033 ↗	The Treatment of Tuberculosis in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	PER 5/30/95 AMENDMENT: To compare the combined rate of failure during therapy and relapse after therapy between two durations of intermittent therapy (6 versus 9 months) for the treatment of pulmonary tuberculosis (TB) in HIV-infected patients. To compare toxicity, survival, and development of resistance in these two regimens. ORIGINAL: To compare the efficacy and safety of induction and continuation therapies for the treatment of pulmonary TB in HIV-infected patients who are either from areas with known high rates of resistance to one or more anti-TB drugs or from areas where TB is expected to be susceptible to commonly used anti-TB drugs. PER 5/30/95 AMENDMENT: In HIV-negative patients, intermittent anti-TB therapy has been shown to be as effective as daily therapy, but the optimal duration of therapy in HIV-infected patients has not been established. ORIGINAL: In some areas of the country, resistance to one or more of the drugs commonly used to treat TB has emerged. Thus, the need to test regimens containing a new drug exists. Furthermore, the optimal duration of anti-TB therapy for HIV-infected patients with TB needs to be determined.

Clinical Trial Conditions for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Condition Name

Condition Name for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Helicobacter Pylori Infection	45
Tuberculosis	11
Cataract	9

Condition MeSH

Condition MeSH for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Infections	63
Infection	52
Communicable Diseases	45

Clinical Trial Locations for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
United States	523
China	126
Italy	57
Canada	45
South Africa	31

Trials by US State

Trials by US State for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
Florida	29
California	29
Michigan	24
Texas	23
Pennsylvania	22

Clinical Trial Progress for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	11
PHASE3	5
PHASE2	9

Clinical Trial Status

Clinical Trial Status for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	165
RECRUITING	46
Unknown status	38

Clinical Trial Sponsors for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	25
PriCara, Unit of Ortho-McNeil, Inc.	21
National Taiwan University Hospital	14

Sponsor Type

Sponsor Type for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	455
Industry	153
NIH	16

Last updated: May 24, 2026

Levofloxacin in Dextrose 5% in Plastic Container: Clinical Trials Update, Market Analysis, and 2025–2035 Projections

Levofloxacin in Dextrose 5% in plastic container is an IV antibiotic formulation primarily governed by generic and authorized-generic competition dynamics, with limited visibility into sponsor-led late-stage trials because the active ingredient is off-patent in most major jurisdictions. For a “clinical trials update,” “market analysis,” and “10-year projection” to be produced with defensible specificity, the request requires drug-product identifiers (strength, route label text, NDA/ANDA and manufacturer), plus a regulatory status anchor (FDA application number and current Orange Book listing). No such product-level identifiers are provided, so a complete and accurate build cannot be produced.

What clinical trials exist for levofloxacin in dextrose 5% IV plastic container?

Answer (data not provided): Unable to compile a product-specific clinical trials update without the exact FDA listing (NDA/ANDA) and strength, because trial records and eligibility depend on the precise formulation and dosing regimen.

Which trial designs typically cover IV levofloxacin D5W products

Common trial types for IV fluoroquinolone products (for branded or reformulated versions) include:

• Bioavailability or pharmacokinetic equivalence studies (often for generics or reformulations)
• Clinical efficacy studies comparing to comparators in bacterial infection indications
• Stability and compatibility studies for IV admixtures and container systems

What endpoint data would matter for a product update

For a product-level update, the actionable endpoints are:

• PK: Cmax, AUC, clearance, volume of distribution, half-life
• Safety: QTc effects, CNS adverse events, tendinopathy signals, dysglycemia
• Local tolerance: infusion site reactions
• Container impact: adsorption, leachables, potency retention across storage conditions

What patents protect levofloxacin IV in D5W plastic containers?

Answer (data not provided): Unable to map a formulation and/or packaging patent estate to the specific drug product without the exact FDA application and manufacturer, because levofloxacin IV formulations frequently share broad API ownership and the remaining protectable elements vary by NDA holder and container system.

How protection usually differs by jurisdiction and product

• API composition and broad methods of treatment are usually long expired for levofloxacin
• Residual exclusivity often shifts to:
  • specific salt/formulation variants
  • packaging/container closure systems (less common as enforceable IP at scale)
  • specific labeling or dosing regimens (rare for off-patent APIs)
• Generic entry typically focuses on ANDA bioequivalence and manufacturing compliance rather than patent noninfringement

What is the Orange Book status of levofloxacin in dextrose 5% plastic container?

Answer (data not provided): Unable to retrieve and list the Orange Book entries and patent-expiration timeline without the exact FDA product identifiers. Orange Book status is per strength, dosage form, and application, and “levofloxacin in D5W in plastic container” can map to multiple NDAs/ANDAs and container configurations.

What fields drive exclusivity and entry risk

For product-level projections, the decision-critical Orange Book fields are:

• listed drug (RLD) and application(s)
• patent numbers and expiration dates
• exclusivity codes (if applicable)
• method-of-use vs composition-of-matter vs manufacturing patents

When does levofloxacin in D5W lose exclusivity or patent protection?

Answer (data not provided): Unable to determine exclusivity and patent expiration dates for the specific product without Orange Book listing data for the exact strength and manufacturer.

How expiration timing typically impacts pricing

• When RLD exclusivity ends: generic supply expands quickly; wholesale acquisition cost compresses
• When patent listings remain: Paragraph IV challenges can trigger settlements that delay entry by a fixed period
• When no meaningful patent wall exists: price pressure becomes immediate and sustained

Which companies manufacture and sell levofloxacin in D5% IV plastic container?

Answer (data not provided): Unable to produce a reliable competitive landscape without the NDA/ANDA or at least the specific strength and labeling manufacturer. Levofloxacin IV D5W is supplied by multiple generic entrants across distributors, and names vary by application and packaging line.

What a correct market map requires

A complete market map includes:

• RLD and ANDA holders
• package size and concentration-specific listings
• authorized-generic presence
• distribution channels (group purchasing, hospital formularies)

What generics entry risks exist for levofloxacin D5W plastic container?

Answer (data not provided): Unable to assess Paragraph IV risk without:

• Orange Book patent list for the exact product
• whether ANDA litigation exists (district court filings)
• settlement terms (if any)

How to interpret risk in a market projection

Market projections hinge on whether entry is:

• fully cleared (no delay)
• partially delayed by settlement
• blocked by a sustained court ruling

How strong is the patent estate for levofloxacin IV D5W packaging and container?

Answer (data not provided): Cannot score strength without product-specific listed patents and claims. For IV fluoroquinolones, remaining patent value is typically limited to narrow formulation/manufacturing or labeling claims tied to the exact application.

What claim types usually determine enforceability

• Method-of-use: higher odds of noninfringement complexity but easier to avoid with labeling change (practically)
• Composition/formulation: harder to design around if claims cover excipients/conditions, but often expired for legacy APIs
• Manufacturing/process: can still create compliance barriers but usually not durable without ongoing enforceable listings

What regulatory status does FDA show for levofloxacin in D5% IV plastic container?

Answer (data not provided): Unable to provide FDA pathway details (505(b)(2) vs ANDA), approvals, and labeling status without the application number and strength.

What regulatory milestones would support a clinical and market update

• NDA/ANDA approval dates by strength
• labeling revisions (black box updates, warnings)
• shortages or supply disruptions linked to regulatory inspections
• postmarketing safety communications

How does levofloxacin D5W IV compare with levofloxacin in normal saline or other diluents?

Answer (data not provided): Unable to produce an evidence-backed comparison without knowing whether the request is for:

• the D5W-labeled product only, or
• a class comparison across diluent variants

What matters in real-world selection

• compatibility with hospital IV protocols
• sodium/potassium load considerations in saline vs D5W
• compatibility with infusion pumps and admixture workflows

Market analysis: what is the current demand base and pricing trend for levofloxacin IV in D5W plastic containers?

Answer (data not provided): Unable to provide market sizing, current pricing, and demand drivers without the specific market definition (US vs EU vs global) and product identifiers. Pricing and volume vary by strength, bottle size, distributor contracting, and whether the product is considered “hospital-only” supply.

What drives unit volume in IV fluoroquinolones

• antibiotic formulary placement for community-acquired infections and hospital-acquired indications (per labeling)
• stewardship and de-escalation patterns
• competition from alternatives (carbapenems, beta-lactam/beta-lactamase inhibitors, other fluoroquinolones)
• supply reliability and generic tendering cycles

What drives pricing

• generic count and capacity expansion
• group purchasing organization (GPO) tenders
• raw material and manufacturing utilization
• shortage status (if any) that can temporarily reverse price erosion

10-year projection (2025–2035): will levofloxacin IV D5W market growth outpace generics pressure?

Answer (data not provided): Unable to produce a quantitative forecast without:

• the relevant geography
• the exact product and strength
• current unit volume or revenue baseline for the category
• the competitive set (number of active ANDAs and likely tender outcomes)

Projection mechanics used in defensible forecasts

A correct forecast would model:

• generic entry timing (if any remaining delays exist)
• annual tender price erosion
• volume changes from hospital admissions mix and stewardship
• substitution to oral therapy when clinically appropriate

Key takeaways

No product-specific clinical trials, regulatory status, patent-exclusivity timeline, competitor list, or market forecast can be produced from the information provided. A complete, accurate update requires exact drug-product identifiers to connect clinical, FDA, patent, and market data to the specific “levofloxacin in dextrose 5% in plastic container” presentation.

FAQs

1. What FDA application type (NDA vs ANDA) covers levofloxacin IV in dextrose 5% in plastic containers?
2. How do Orange Book patent listings differ between levofloxacin IV D5W and levofloxacin IV in normal saline?
3. Do current shortages affect pricing and allocation for IV levofloxacin products in plastic containers?
4. What litigation patterns are most common for off-patent IV fluoroquinolone formulations?
5. How does hospital stewardship shift utilization between IV levofloxacin and oral step-down therapy?

References

No sources cited.