CLINICAL TRIALS PROFILE FOR GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

All Clinical Trials for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00671528 ↗	Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4)	Terminated	Merck Sharp & Dohme Corp.	Phase 4	2009-07-01	This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial comparing three creams in the treatment of impetiginous eczema: - Arm A: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) - Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream - Arm C: Betamethasone diproprionate cream At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1:1:1 randomization ratio to receive one of the three possible treatments for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. Assessments will be made of level of improvement of the target area in each treatment group, number of days for total remission, and safety profile. Note: This study was terminated early due to lack of recruitment (only 3 of the 207 planned participants were enrolled). Statistical analyses were not performed. Further, 7 sites were planned, but only 4 sites were approved out of which 3 sites were initiated.
NCT01878643 ↗	Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit	Completed	Stony Brook University	Early Phase 1	2001-12-01	The purpose of this study was : - to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients - to determine the effect of inhaled antibiotics on respiratory infection
NCT02036528 ↗	Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers	Terminated	Royer Biomedical, Inc.	Phase 1/Phase 2	2014-01-01	The purpose of this study is to determine whether AppliGel-G (Gentamicin topical gel) plus oral Ciprofloxacin / Doxycycline are safe and effective in the treatment of mild to moderately infected foot ulcers in diabetic patients.
NCT03012191 ↗	Gentamicin for RDEB	Completed	University of Southern California	Phase 1/Phase 2	2017-02-02	Recessive dystrophic epidermolysis bullosa (RDEB) is an incurable, devastating, inherited skin disease caused by mutations in the COL7A1 gene that encodes for type VII collagen (C7), the major component of anchoring fibrils (AFs), structures that mediate epidermal-dermal adherence. Thirty percent of RDEB patients have nonsense mutations. The investigators recently demonstrated in 5 such patients that intradermal and topical gentamicin induced "read-through" of their nonsense mutations and created robust and sustained new C7 and AFs at the dermal-epidermal junction (DEJ) of their skin and also stimulated wound closure and reduced new blister formation. No untoward side effects occurred. Herein, the investigators propose evaluating the safety and efficacy of intravenous gentamicin in these patients. In theory, this intravenous administration has the possibility of treating simultaneously all of the patients' skin wounds. The investigators also propose optimizing the concentration and manner of delivery of topical gentamicin. The unambiguous milestones will be increased C7 and AFs in the patients' DEJ, improved EB Disease Activity Scores, and absence of significant gentamicin side effects.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Alphacait, LLC	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Haining Health-Coming Biotech Co., Ltd.	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03392909 ↗	Intravenous Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB)	Recruiting	University of Southern California	Phase 1/Phase 2	2018-07-05	Recessive dystrophic epidermolysis bullosa (RDEB) is an incurable, devastating, inherited skin disease caused by mutations in the COL7A1 gene that encodes for type VII collagen (C7), the major component of anchoring fibrils (AFs), structures that mediate epidermal-dermal adherence. Thirty percent of RDEB patients have nonsense mutations. The investigators recently demonstrated in 5 such patients that intradermal and topical gentamicin induced "read-through" of their nonsense mutations and created robust and sustained new C7 and AFs at the dermal-epidermal junction (DEJ) of their skin and also stimulated wound closure and reduced new blister formation. No untoward side effects occurred. Herein, the investigators propose evaluating the safety and efficacy of intravenous gentamicin in these patients. In theory, this intravenous administration has the possibility of treating simultaneously all of the patients' skin wounds. The milestones will be increased C7 and AFs in the patients' DEJ, improved EB Disease Activity Scores, and absence of gentamicin side effects.

Clinical Trial Conditions for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Condition Name

Condition Name for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Recessive Dystrophic Epidermolysis Bullosa	2
Spinal Cord Injuries	2
Neurogenic Bladder	2
Pelvic Organ Prolapse	1

Condition MeSH

Condition MeSH for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Epidermolysis Bullosa	4
Infections	3
Infection	3
Urinary Tract Infections	3

Clinical Trial Locations for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
United States	13
Kenya	1
China	1
Norway	1

Trials by US State

Trials by US State for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
California	4
Michigan	2
Kentucky	1
Utah	1
Maryland	1

Clinical Trial Progress for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Recruiting	5
Terminated	2
Completed	2

Clinical Trial Sponsors for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
University of Southern California	3
National Institute for Health Research, United Kingdom	1
University of Nairobi	1

Sponsor Type

Sponsor Type for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Other	20
Industry	2

Last updated: July 28, 2026

Gentamicin Sulfate in 0.9% Sodium Chloride in Plastic Container: Clinical Trials Update, Market Outlook, and Forecast

Gentamicin sulfate in 0.9% sodium chloride in plastic containers is an established generic injectable for systemic use (typically hospital-administered for susceptible bacterial infections). A modern “clinical trials update” for this exact combination is not actionable because gentamicin has long-established clinical evidence and the product is broadly supplied as a generic formulation with bioequivalence-based approvals rather than stand-alone pivotal trials for new indications. The near-term market outlook is driven by hospital formularies, antibiotic stewardship, supply reliability, and generic pricing rather than trial innovation.

Is there new clinical trial activity for gentamicin sulfate in sodium chloride 0.9% (plastic container)?

What counts as a “trial update” for this product

For a long-market-history parenteral antibiotic like gentamicin, “updates” usually fall into four buckets rather than new efficacy trials:

• Formulation and container lifecycle work (stability, compatibility, leachables/extractables, shelf-life extensions).
• Bioequivalence and/or bridging studies for generic manufacturing changes.
• Safety and stewardship studies at the class level (aminoglycosides, nephrotoxicity monitoring, dosing strategies).
• Pharmacokinetic (PK) and dosing optimization studies in special populations (neonates, pediatrics, obesity, renal impairment).

Because gentamicin itself is not novel, the most operationally relevant updates for business planning are typically CMC and regulatory lifecycle changes, not new clinical endpoints.

Where trial signals usually show up

• Hospital antimicrobial stewardship programs increasingly target aminoglycoside use duration and therapeutic drug monitoring (TDM) practices.
• PK modeling work influences dosing guidance, which can shift utilization patterns (less frequent use, different dose scheduling).
• Inpatient antimicrobial protocols can change line-of-therapy placement, affecting volume.

What is the current FDA regulatory status for gentamicin sulfate in 0.9% sodium chloride 0.9% plastic container (Orange Book)?

Orange Book status drivers for this injectable

For combination products of an established API (gentamicin sulfate) in a common diluent (0.9% sodium chloride) and a standard plastic container, the Orange Book listing typically reflects:

• A generic approval pathway (ANDAs or abbreviated reliance on existing safety/efficacy via bioequivalence).
• Multiple label strengths and container configurations.
• Periodic supplements for manufacturing changes or updated packaging.

Practical consequence for market forecasting: entry timing is less constrained by “exclusivity” and more constrained by supply continuity, quality system performance, and any patent or regulatory exclusivities that could attach to specific label strengths, manufacturing methods, or reformulations.

Data needed to map exact exclusivity

A precise Orange Book and exclusivity timeline requires the exact listed drug identity as shown on the Orange Book (active ingredient, strength, dosage form, route, and manufacturer listing). Without that exact mapping to the Orange Book record(s) for this specific “plastic container” product identity, a reliable exclusivity calendar cannot be produced.

What patents protect gentamicin sulfate in 0.9% sodium chloride (plastic container) and how strong is the estate?

How patent estates typically look for older injectable antibiotics

For gentamicin injectable solutions, patent protection generally narrows to one or more of the following:

• Process or manufacturing method patents for specific solids control, filtration, sterilization conditions, or scaling steps.
• Formulation stabilization patents (buffering, pH control, antioxidant or chelator use, if applicable).
• Container/packaging compatibility and extractables control patents (less common as enforceable, but can exist).
• Any remaining polymorph/crystal form patents do not usually apply because gentamicin sulfate is a longstanding substance and the product is a solution.

In most scenarios, the effective IP barrier for this product type is low because generics enter based on bioequivalence and rely on an established clinical record. Where barriers exist, they are more often tied to a specific manufacturing site, process controls, or brand-specific patent enforcement from a particular sponsor rather than to the base API and diluent combination.

When does gentamicin sulfate in 0.9% sodium chloride lose exclusivity for generics to enter?

For older, widely genericized antibiotics in standard diluent solutions, exclusivity events are usually exhausted. Any remaining exclusivity would be specific to:

• A particular NDA/ANDA reference listed drug (RLD) record.
• A specific strength/package configuration.
• A specific supplemental approval (label expansion, new container, or manufacturing change that created a Hatch-Waxman exclusivity event).

A reliable “loss of exclusivity” answer depends on identifying the governing RLD and the exclusivity period attached to it. Without the exact Orange Book listing mapping, producing a date is not possible.

What Paragraph IV challenges exist for gentamicin sulfate injections (and which companies are contesting them)?

Paragraph IV challenges are generally concentrated on products with meaningful remaining brand exclusivity or patent cover. For a ubiquitous injectable antibiotic formulation in common diluent and standard plastic container, Paragraph IV activity is typically limited or absent unless a specific sponsor still holds enforceable, listed patents for a defined RLD strength/package.

A defensible competitive assessment requires:

• The Orange Book listed patents for the applicable RLD.
• ANDA applicant history and litigation dockets (FDA 30-day notice triggers, district court actions). Without those exact listings and docket links, listing “current” Paragraph IV cases would be speculative.

What is the market size and demand base for gentamicin sulfate 0.9% sodium chloride plastic containers?

Primary demand drivers

• Inpatient antibiotic utilization for susceptible gram-negative infections.
• ICU and hospital acute-care protocols that use aminoglycosides with TDM.
• Dosing strategies in renal impairment and pediatrics that affect per-patient dosing.
• Supply and substitution behavior within the aminoglycoside class (gentamicin vs tobramycin vs amikacin depending on susceptibility and toxicity profiles).

Commercial reality for this product category

This is a hospital generic category with:

• Pricing driven by government tenders, wholesaler contracts, and group purchasing organizations.
• Volume sensitivity to stock availability and procurement switching.
• Demand stability relative to new therapeutics because it is used as standard-of-care in selected clinical scenarios.

How will hospital procurement, shortages, and antibiotic stewardship affect pricing for this product?

Procurement and pricing mechanics

• Multi-source availability tends to cap price growth.
• Any manufacturer supply disruption can temporarily widen pricing and reorder cycles.
• Contract cycles and rebid timing can create short-lived swings.

Stewardship effects

Antibiotic stewardship reduces unnecessary aminoglycoside exposure, which can:

• Shift clinicians toward narrower-spectrum alternatives when possible.
• Encourage shorter courses with rapid de-escalation after cultures.
• Reinforce TDM to reduce nephrotoxicity, potentially altering dosing frequency.

Net effect in mature generic markets is usually stable-to-slightly down volume growth rather than dramatic structural demand loss, unless stewardship sharply de-prioritizes aminoglycosides in guideline revisions for common infection syndromes.

How many competitors supply gentamicin sulfate in sodium chloride 0.9% plastic containers and what is the concentration risk?

In established injectable antibiotic segments, competition often includes:

• Multiple ANDA manufacturers across several strengths.
• Variability by region based on contract awards.
• Occasional consolidation of effective supply after plant shutdowns or quality issues.

A concentration-risk assessment requires actual number of ANDA/labeler entries for the exact drug/strength/container configuration. Without the specific Orange Book mapping, any competitor count would be unreliable.

What generic entry risks exist for gentamicin sulfate in 0.9% sodium chloride (plastic container)?

Key entry barriers in mature generics

Even when the API is off-patent, generic entry and sustainable supply can be limited by:

• Sterile manufacturing capacity for large-volume parenteral solutions.
• Validation timelines for aseptic process control.
• Stability and compatibility requirements for plastic container systems.
• Regulatory inspection outcomes at the manufacturing site.

For market projection, this means the real competitive constraint is often supply reliability, not legal exclusivity.

How does gentamicin sulfate 0.9% sodium chloride compare with alternative aminoglycosides in hospital use?

Relative positioning

• Gentamicin is commonly used for susceptible gram-negative infections where cost and availability favor it.
• Amikacin often has a different resistance profile and can be used when gentamicin resistance is common.
• Tobramycin is used in certain contexts, including select infections where it is preferred or when susceptibility patterns align.

Net impact: switching among aminoglycosides can happen quickly when one product is unavailable or when local resistance patterns change. This supports demand elasticity within the class.

Clinical trial pipeline: what is most likely to change for gentamicin injectable products?

Given the product’s age and genericization, the pipeline that matters is likely:

• Container and packaging lifecycle changes (improved shelf-life, different plastic formulations).
• Manufacturing improvements that reduce impurities and improve stability.
• Label updates related to monitoring (TDM, renal function protocols) driven by accumulating observational and stewardship data.

These changes rarely create premium market opportunities, but they can affect tender preference.

---

Key Takeaways

• Clinical novelty is unlikely for gentamicin sulfate in 0.9% sodium chloride plastic containers; the operational “update” is typically CMC/regulatory lifecycle and stewardship-driven utilization changes.
• Market outlook is driven by hospital procurement contracting, supply reliability, and antibiotic stewardship policies rather than new trial efficacy.
• Legal exclusivity and patent barriers for this type of established generic injectable are usually limited, with any residual barriers tied to specific RLD records, strengths, and manufacturing method/process patents.
• Competitive dynamics are primarily supply- and contract-driven; demand is relatively stable but pricing is capped by multi-source availability.

---

FAQs

1. Are there any active NDAs/ANDAs specifically for gentamicin sulfate in 0.9% sodium chloride plastic container with new indications?
2. Do hospital shortages of gentamicin change utilization patterns versus tobramycin or amikacin?
3. How do therapeutic drug monitoring and nephrotoxicity risk policies influence aminoglycoside volume in hospitals?
4. What manufacturing or container changes most often trigger FDA supplements for generic sterile injectables like this?
5. What factors determine tender wins for multi-source gentamicin injectables in US group purchasing organizations?

---

References (APA)

No sources are cited because no verifiable Orange Book, FDA labeling, litigation dockets, or trial registry records were provided or accessible within the request context.