CLINICAL TRIALS PROFILE FOR MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT01589497 ↗	Essentiality of INH in TB Therapy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2015-06-30	Tuberculosis (TB) disease is caused by bacteria that have infected the lung. TB bacteria are very small living agents that are spread by coughing and can be killed by taking TB drugs. To kill these TB bacteria TB patients have to take a combination of four drugs for 2 months and then two drugs for a further 4 months. During the first 2 months patients take rifampicin, isoniazid, ethambutol, and pyrazinamide. After that patients take only isoniazid and rifampicin for a further 4 months, making a total of 6 months therapy. In A5307 the investigators wanted to test a new combination of drugs to see if the investigators could treat TB faster in the future. Studies in animals have suggested that one of the four drugs, isoniazid, only works for a few days and may not be needed after the first two doses of TB treatment to kill the TB bacteria. After that its effects wear off to the point that it may even interfere with the other drugs. The investigators wanted to see if stopping isoniazid early, or using moxifloxacin, a different drug, instead could treat TB faster. This study was the first time that this type of regimen without isoniazid had been tested in humans. If the investigators could show that isoniazid stops working after a few days, the investigators could then try to see if they could possibly make a better tuberculosis treatment in the future.
New Combination	NCT01589497 ↗	Essentiality of INH in TB Therapy	Completed	AIDS Clinical Trials Group	Phase 2	2015-06-30	Tuberculosis (TB) disease is caused by bacteria that have infected the lung. TB bacteria are very small living agents that are spread by coughing and can be killed by taking TB drugs. To kill these TB bacteria TB patients have to take a combination of four drugs for 2 months and then two drugs for a further 4 months. During the first 2 months patients take rifampicin, isoniazid, ethambutol, and pyrazinamide. After that patients take only isoniazid and rifampicin for a further 4 months, making a total of 6 months therapy. In A5307 the investigators wanted to test a new combination of drugs to see if the investigators could treat TB faster in the future. Studies in animals have suggested that one of the four drugs, isoniazid, only works for a few days and may not be needed after the first two doses of TB treatment to kill the TB bacteria. After that its effects wear off to the point that it may even interfere with the other drugs. The investigators wanted to see if stopping isoniazid early, or using moxifloxacin, a different drug, instead could treat TB faster. This study was the first time that this type of regimen without isoniazid had been tested in humans. If the investigators could show that isoniazid stops working after a few days, the investigators could then try to see if they could possibly make a better tuberculosis treatment in the future.
New Indication	NCT03257423 ↗	Acute Appendicitis and Microbiota - Etiology of Appendicitis and Antibiotic Therapy Effects	Enrolling by invitation	Helsinki University Central Hospital	N/A	2017-04-04	Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine procedure. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. The previous APPAC study by the investigators, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with uncomplicated appendicitis treated successfully with antibiotics. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings. On the other hand, antibiotic therapies have been shown to have an effect on the normal gut microbiota and are considered an increasing global health threat underlining the importance of evaluating both short- and long-term effects of the antimicrobial treatment in old and new indications. The aims of this randomized prospective study are: 1. To evaluate the possible role and differences in the microbiological etiology of complicated and uncomplicated appendicitis. 2. To determine the effects of both antibiotic and placebo treatment on the composition of gut microbiota, and to evaluate how it recovers after the appendicitis-related antimicrobial treatment (AMT) 3. To evaluate the effects of the duration of the hospital stay on the AMR reservoir of the gut microbiota.
New Indication	NCT03257423 ↗	Acute Appendicitis and Microbiota - Etiology of Appendicitis and Antibiotic Therapy Effects	Enrolling by invitation	Jyväskylä Central Hospital	N/A	2017-04-04	Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine procedure. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. The previous APPAC study by the investigators, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with uncomplicated appendicitis treated successfully with antibiotics. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings. On the other hand, antibiotic therapies have been shown to have an effect on the normal gut microbiota and are considered an increasing global health threat underlining the importance of evaluating both short- and long-term effects of the antimicrobial treatment in old and new indications. The aims of this randomized prospective study are: 1. To evaluate the possible role and differences in the microbiological etiology of complicated and uncomplicated appendicitis. 2. To determine the effects of both antibiotic and placebo treatment on the composition of gut microbiota, and to evaluate how it recovers after the appendicitis-related antimicrobial treatment (AMT) 3. To evaluate the effects of the duration of the hospital stay on the AMR reservoir of the gut microbiota.
New Indication	NCT03257423 ↗	Acute Appendicitis and Microbiota - Etiology of Appendicitis and Antibiotic Therapy Effects	Enrolling by invitation	Kuopio University Hospital	N/A	2017-04-04	Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine procedure. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. The previous APPAC study by the investigators, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with uncomplicated appendicitis treated successfully with antibiotics. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings. On the other hand, antibiotic therapies have been shown to have an effect on the normal gut microbiota and are considered an increasing global health threat underlining the importance of evaluating both short- and long-term effects of the antimicrobial treatment in old and new indications. The aims of this randomized prospective study are: 1. To evaluate the possible role and differences in the microbiological etiology of complicated and uncomplicated appendicitis. 2. To determine the effects of both antibiotic and placebo treatment on the composition of gut microbiota, and to evaluate how it recovers after the appendicitis-related antimicrobial treatment (AMT) 3. To evaluate the effects of the duration of the hospital stay on the AMR reservoir of the gut microbiota.
New Indication	NCT03257423 ↗	Acute Appendicitis and Microbiota - Etiology of Appendicitis and Antibiotic Therapy Effects	Enrolling by invitation	Oulu University Hospital	N/A	2017-04-04	Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine procedure. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. The previous APPAC study by the investigators, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with uncomplicated appendicitis treated successfully with antibiotics. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings. On the other hand, antibiotic therapies have been shown to have an effect on the normal gut microbiota and are considered an increasing global health threat underlining the importance of evaluating both short- and long-term effects of the antimicrobial treatment in old and new indications. The aims of this randomized prospective study are: 1. To evaluate the possible role and differences in the microbiological etiology of complicated and uncomplicated appendicitis. 2. To determine the effects of both antibiotic and placebo treatment on the composition of gut microbiota, and to evaluate how it recovers after the appendicitis-related antimicrobial treatment (AMT) 3. To evaluate the effects of the duration of the hospital stay on the AMR reservoir of the gut microbiota.

All Clinical Trials for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00042289 ↗	Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)		2003-03-01	The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
NCT00042289 ↗	Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)		2003-03-01	The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
NCT00062231 ↗	Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer	Terminated	European Organisation for Research and Treatment of Cancer - EORTC	N/A	2002-04-01	RATIONALE: Antibiotics such as amoxicillin, ciprofloxacin, and moxifloxacin may be effective in preventing or controlling fever and neutropenia in patients with cancer. It is not yet known whether moxifloxacin alone is more effective than amoxicillin combined with ciprofloxacin in treating neutropenia and fever. PURPOSE: This randomized clinical trial is studying how well moxifloxacin works and compares it to ciprofloxacin together with amoxicillin in treating neutropenia and fever in patients with cancer.
NCT00082173 ↗	Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis	Completed	Johns Hopkins University	Phase 2	2004-10-01	Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and then two drugs for 4 months. New drug regimens that are shorter and effective against drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively treat TB.
NCT00140309 ↗	TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment	Completed	Centers for Disease Control and Prevention	Phase 2	2003-07-01	This study is a placebo-controlled factorial study, randomized to study drug (moxifloxacin vs. ethambutol) and treatment frequency (daily vs. thrice weekly after an initial two weeks of daily therapy) during the first two months of standard treatment (with isoniazid, rifampin, and pyrazinamide) for sputum smear-positive pulmonary tuberculosis.
NCT00144417 ↗	TBTC Study 28: Moxifloxacin Versus Isoniazid for TB Treatment	Completed	Bayer	Phase 2	2006-02-01	This double-blind, randomized controlled trial evaluates moxifloxacin versus isoniazid in daily treatment during the first two months of treatment with rifampin, pyrazinamide and ethambutol for sputum smear-positive pulmonary tuberculosis.

Clinical Trial Conditions for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Condition Name

Condition Name for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Intervention	Trials
Healthy	92
Healthy Volunteers	31
Tuberculosis	23
Healthy Subjects	20

Condition MeSH

Condition MeSH for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Intervention	Trials
Tuberculosis	58
Tuberculosis, Pulmonary	33
Cataract	24
Infections	23

Clinical Trial Locations for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Location	Trials
United States	512
South Africa	113
Germany	100
China	89
United Kingdom	60

Trials by US State

Trials by US State for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Location	Trials
Texas	57
California	35
Florida	32
Arizona	31
Maryland	28

Clinical Trial Progress for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	7
PHASE2	4

Clinical Trial Status

Clinical Trial Status for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	365
Recruiting	64
Not yet recruiting	28

Clinical Trial Sponsors for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Sponsor	Trials
Bayer	34
GlaxoSmithKline	20
Pfizer	18

Sponsor Type

Sponsor Type for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Sponsor	Trials
Other	476
Industry	442
NIH	16

Last updated: July 28, 2026

Moxifloxacin Hydrochloride in Sodium Chloride 0.8% in Plastic Container: Clinical Trials Update, Market Analysis, and Forecast

Moxifloxacin hydrochloride in 0.8% sodium chloride, in plastic container, is an IV antibiotic product positioned for bacterial infections requiring parenteral therapy. Publicly actionable commercialization intelligence and a trial-by-trial update cannot be produced from the information provided because the product’s exact FDA label, NDC(s), sponsor/ANDA/505(b)(2) pathway, and corresponding clinical-trial registrations are not specified.

What is moxifloxacin hydrochloride in sodium chloride 0.8% in plastic container used for clinically?

Direct answer: The product is used as an IV fluoroquinolone antibiotic for infections where clinicians select moxifloxacin therapy and IV administration is required. Precise indication mapping requires the specific approved label tied to the referenced NDC and manufacturer.

What infections are typically covered in moxifloxacin IV labeling?

Key indication groupings for moxifloxacin products (by molecule class) generally include community-acquired bacterial pneumonia and complicated skin/skin structure infections, with additional label-specific limits based on country and formulation. Exact scope for this specific IV saline container depends on the FDA prescribing information for the listed strength and container type.

What clinical trials exist for moxifloxacin IV in saline, and what is the latest update?

Direct answer: A current “latest update” cannot be compiled for this exact formulation without the product’s clinical-trial identifier set (e.g., NCT numbers) tied to the specific IV saline container product.

Which trial types matter for a supply-side update?

Investors typically track:

• Phase 1 PK/BE trials for the IV drug product and container/solution system
• Phase 3 comparative efficacy trials vs levofloxacin, ciprofloxacin, or beta-lactam regimens
• Safety updates on QT prolongation and tendon adverse events
• Formulation comparability studies addressing plastic container and saline matrix

Who are the manufacturers and what is the Orange Book status for moxifloxacin hydrochloride in this IV saline container?

Direct answer: Orange Book status, listed patents, and exclusivity cannot be determined from the information provided.

What to check on the FDA Orange Book for this product

For a commercialization risk model, the essential fields are:

• FDA application number and approval type (NDA vs 505(b)(2) vs ANDA)
• Listed drug submission and active ingredient salt
• Patent list (drug substance, drug product, and methods of use)
• Exclusivity codes (e.g., NCE, 3-year, 5-year, pediatric extensions)
• Current market authorization status

When does exclusivity expire and when can generics enter?

Direct answer: Exclusivity and patent-expiration dates cannot be stated for this exact product without Orange Book patent and exclusivity listings tied to its FDA application and NDC.

What generic entry scenarios typically depend on

• Whether the listed patents include formulation and/or method-of-use claims
• Whether a Paragraph IV ANDA is already pending
• Whether the reference listed drug has additional pediatric exclusivity extensions
• Whether court stays or settlements delay first-to-file launch

What is the patent estate strength for moxifloxacin IV saline plastic container products?

Direct answer: A patent-strength assessment cannot be produced without the specific listed patents for the referenced product and its application family.

Patent estate inputs that drive litigation and launch timing

• Count of active composition and method patents in the Orange Book
• Claims covering container/solution system, pH control, excipients, and stability
• Claim scope relative to generic formulation freedom
• Prior litigation involving the same reference product or close family members

What patent litigation affects moxifloxacin IV products and potential generic launches?

Direct answer: Litigation history cannot be mapped to this exact formulation without the relevant reference product listing, applicant names, and dockets.

What to look for in court records

• Paragraph IV case identification tied to the same FDA application
• Whether settlements include non-expiration payments or early-launch carve-outs
• Whether there are active appeals affecting launch dates
• Whether injunctions target the same container/solution configuration

How does this IV formulation compare with other moxifloxacin IV products in the market?

Direct answer: Comparative analysis cannot be completed without:

• Strength, concentration, and container configuration for each comparator
• NDC-level differences (glass vs plastic, premix vs unit dose)
• Approved indications and labeling contraindications that affect physician choice

Competitive dimensions that move volume

• Price and wholesaler reimbursement dynamics
• Availability and supply reliability for IV plastic containers
• Substitution rules at hospital formularies
• Shortage or discontinuation events

What is the market size for IV moxifloxacin, and what is the projection for this exact product?

Direct answer: A market-size and forecast model for “moxifloxacin hydrochloride in sodium chloride 0.8% in plastic container” cannot be produced from the provided prompt because the forecast requires:

• NDC-specific historical sales (or a defined proxy like total IV moxifloxacin sales)
• Country scope (US-only vs multi-country)
• Contract pricing, ASP trends, and inventory/supply constraints tied to that exact listing

What a robust projection needs to separate

• Total molecule demand (moxifloxacin) vs share of IV vs oral
• Container format effects (plastic container vs alternative packaging)
• Hospital mix (community vs inpatient, antimicrobial stewardship pathways)
• Generic share penetration under confirmed launch timing

What clinical and safety signals drive demand for IV fluoroquinolones?

Direct answer: Demand is sensitive to safety labeling and prescribing restrictions for fluoroquinolones, which affects clinicians’ selection and duration of IV therapy. Product-specific label wording and updates determine real-world utilization.

QT and other safety topics that influence use

Key decision points include:

• QT prolongation risk and monitoring requirements
• Tendon disorders and peripheral neuropathy warnings
• Contraindications and cautions that can reduce eligible patient pools
• Antimicrobial stewardship protocols and prior authorization rules

Key takeaways

• A clinical-trials update, Orange Book status, exclusivity timeline, patent-litigation mapping, and sales forecast for this specific IV formulation cannot be generated from the information provided.
• A complete market projection requires NDC-level linkage to FDA approvals and a defined geographic scope, plus historical sales inputs or a stated proxy.

FAQs

1. How can NDC-level differences affect competition and substitution for IV moxifloxacin products?
2. What endpoints in fluoroquinolone Phase 3 programs most influence formulary uptake and payer coverage?
3. What Orange Book exclusivity types most commonly delay generic IV antibiotic launch?
4. How do container format and stability studies influence generic ANDA approval for IV solutions?
5. What safety-label updates most change hospital prescribing patterns for moxifloxacin?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (n.d.). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. ClinicalTrials.gov. (n.d.). U.S. National Library of Medicine. https://clinicaltrials.gov/