CLINICAL TRIALS PROFILE FOR AMOXICILLIN; CLAVULANATE POTASSIUM

All Clinical Trials for amoxicillin; clavulanate potassium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002149 ↗	Acupuncture and Herbal Treatment of Chronic HIV Sinusitis	Completed	Immune Enhancement Project	N/A	1969-12-31	To compare Traditional Chinese Medicine versus standard antibiotic therapy consisting of pseudoephedrine ( Sudafed ) plus amoxicillin / clavulanate potassium combination ( Augmentin ) in reducing symptoms and recurrence of acute HIV-related sinusitis. Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of life-threatening sepsis, and progress to central nervous system involvement. Symptoms of sinusitis in HIV patients are often refractory to aggressive Western medical management, and antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic therapy.
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.
NCT00132275 ↗	Guidelines for Acute Sinusitis	Completed	Thrasher Research Fund	N/A	2003-11-01	Viral upper respiratory infections occur frequently during childhood (6-8 per year) and are, for the most part, self-limited episodes that resolve spontaneously and do not require antibiotic therapy. Acute otitis media and acute bacterial sinusitis are frequent complications of viral upper respiratory infections that will benefit from treatment with antibiotics. Acute bacterial sinusitis is one of the most common diagnoses in ambulatory practice and, in all age groups, accounts for an estimated 25 million physician office visits annually. It is essential to distinguish between patients who are experiencing uncomplicated viral upper respiratory infections and acute bacterial sinusitis to avoid the excessive use of antibiotics for patients who will not benefit from them. This is especially important now because of the escalation of antibiotic resistance among the bacteria that commonly cause acute bacterial sinusitis, acute otitis media and pneumonia. Inappropriate use of antibiotics is a major contributor to the problem of antimicrobial resistance - a problem which dramatically increases both the cost and complexity of treatment. To improve the diagnosis and treatment of patients with acute bacterial sinusitis and reduce the inappropriate use of antibiotics, clinical guidelines have been developed by three national organizations: the American Academy of Pediatrics, the Sinus and Allergy Health Partnership and the Centers for Disease Control and Prevention. Traditionally, the diagnosis of acute bacterial sinusitis is suspected on the basis of clinical signs and symptoms and is confirmed with the performance of images (either plain radiographs, computed tomography or magnetic resonance imaging). All three guidelines recommend that the diagnosis and treatment of acute bacterial sinusitis should be based on clinical criteria alone without the confirmation of imaging or other laboratory data. Although the similarity between the different guidelines suggests that there is widespread consensus to use clinical criteria to diagnose acute bacterial sinusitis, there is virtually no evidence to support this position. Specific Aim 1 of this project is to evaluate the use of clinical criteria, without the performance of images, as the basis for the diagnosis of acute bacterial sinusitis. A randomized, placebo-controlled study design will be used to determine if the clinical criteria proposed by the different guidelines can be used to identify children with upper respiratory symptoms who will respond to antibiotic therapy. It is expected that children with acute bacterial sinusitis who receive an antimicrobial will recover more quickly and more often than children who receive placebo.
NCT00132275 ↗	Guidelines for Acute Sinusitis	Completed	University of Pittsburgh	N/A	2003-11-01	Viral upper respiratory infections occur frequently during childhood (6-8 per year) and are, for the most part, self-limited episodes that resolve spontaneously and do not require antibiotic therapy. Acute otitis media and acute bacterial sinusitis are frequent complications of viral upper respiratory infections that will benefit from treatment with antibiotics. Acute bacterial sinusitis is one of the most common diagnoses in ambulatory practice and, in all age groups, accounts for an estimated 25 million physician office visits annually. It is essential to distinguish between patients who are experiencing uncomplicated viral upper respiratory infections and acute bacterial sinusitis to avoid the excessive use of antibiotics for patients who will not benefit from them. This is especially important now because of the escalation of antibiotic resistance among the bacteria that commonly cause acute bacterial sinusitis, acute otitis media and pneumonia. Inappropriate use of antibiotics is a major contributor to the problem of antimicrobial resistance - a problem which dramatically increases both the cost and complexity of treatment. To improve the diagnosis and treatment of patients with acute bacterial sinusitis and reduce the inappropriate use of antibiotics, clinical guidelines have been developed by three national organizations: the American Academy of Pediatrics, the Sinus and Allergy Health Partnership and the Centers for Disease Control and Prevention. Traditionally, the diagnosis of acute bacterial sinusitis is suspected on the basis of clinical signs and symptoms and is confirmed with the performance of images (either plain radiographs, computed tomography or magnetic resonance imaging). All three guidelines recommend that the diagnosis and treatment of acute bacterial sinusitis should be based on clinical criteria alone without the confirmation of imaging or other laboratory data. Although the similarity between the different guidelines suggests that there is widespread consensus to use clinical criteria to diagnose acute bacterial sinusitis, there is virtually no evidence to support this position. Specific Aim 1 of this project is to evaluate the use of clinical criteria, without the performance of images, as the basis for the diagnosis of acute bacterial sinusitis. A randomized, placebo-controlled study design will be used to determine if the clinical criteria proposed by the different guidelines can be used to identify children with upper respiratory symptoms who will respond to antibiotic therapy. It is expected that children with acute bacterial sinusitis who receive an antimicrobial will recover more quickly and more often than children who receive placebo.
NCT00135603 ↗	Antibiotic Therapy Versus Appendectomy for Acute Appendicitis	Completed	Assistance Publique - Hôpitaux de Paris	N/A	2004-02-01	The purpose of the study is to demonstrate that antibiotic therapy is as safe and effective as appendectomy for the treatment of acute non complicated appendicitis. Two hundred fifty patients will be included in a prospective multicentric randomized trial. The primary endpoint is the rate of intra abdominal infections in both therapeutic strategies. Other criteria will be studied including duration of hospital stay and absence from work during a follow up period of one year, parietal and abdominal complications and recurrent appendicitis after antibiotic therapy.

Clinical Trial Conditions for amoxicillin; clavulanate potassium

Condition Name

Condition Name for amoxicillin; clavulanate potassium
Intervention	Trials
Sinusitis	4
Neutropenia	2
Healthy	2
Unspecified Adult Solid Tumor, Protocol Specific	2

Condition MeSH

Condition MeSH for amoxicillin; clavulanate potassium
Intervention	Trials
Sinusitis	5
Pneumonia, Bacterial	2
Pneumonia	2
Neutropenia	2

Clinical Trial Locations for amoxicillin; clavulanate potassium

Trials by Country

Trials by Country for amoxicillin; clavulanate potassium
Location	Trials
United States	27
Poland	4
Argentina	3
Panama	3
United Kingdom	3

Trials by US State

Trials by US State for amoxicillin; clavulanate potassium
Location	Trials
Pennsylvania	5
California	4
Arkansas	3
Ohio	3
Utah	2

Clinical Trial Progress for amoxicillin; clavulanate potassium

Clinical Trial Phase

Clinical Trial Phase for amoxicillin; clavulanate potassium
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	2
Phase 3	7

Clinical Trial Status

Clinical Trial Status for amoxicillin; clavulanate potassium
Clinical Trial Phase	Trials
Completed	11
Terminated	4
Unknown status	2

Clinical Trial Sponsors for amoxicillin; clavulanate potassium

Sponsor Name

Sponsor Name for amoxicillin; clavulanate potassium
Sponsor	Trials
Pfizer	3
Teva Pharmaceuticals USA	2
Janssen Research & Development, LLC	2

Sponsor Type

Sponsor Type for amoxicillin; clavulanate potassium
Sponsor	Trials
Other	16
Industry	10

Amoxicillin/Clavulanate Potassium Clinical Trials Update and Market Forecast: What’s Driving Demand, Pricing, and Generic Risk

Last updated: July 28, 2026

What is the current clinical trial pipeline for amoxicillin clavulanate potassium?

Amoxicillin/clavulanate (co-amoxiclav) is a long-established antibacterial combination. Clinical-trial activity is dominated by (i) bioequivalence and formulation studies, (ii) pediatric and special-population studies, and (iii) trials tied to new delivery systems or dosing regimens rather than late-stage, novel-mechanism development.

Pipeline pattern that matters commercially

• Most “clinical trials” are BE or reformulation trials rather than registrational Phase 3 programs.
• New entrant R&D is often aimed at extending IP around salts, ratios, dosing regimens, or administration systems, not the core active ingredients.
• Registration strategy is typically generic-style (where allowed) or brand-extension style (new formulation claims), because core chemistry is off-patent.

Featured-scope trial categories observed for co-amoxiclav

• Bioequivalence in adults and children
• Weight-based pediatric dosing confirmation
• Safety and tolerability studies in renal impairment
• Studies supporting new dispersible/tablet strengths or modified release (when pursued)

Bottom line For amoxicillin/clavulanate, trial updates tend to translate into market share shifts via product differentiation rather than major pipeline-driven supply or value expansion.

Which companies are active in amoxicillin/clavulanate trials and next-generation formulations?

The commercial ecosystem for co-amoxiclav is primarily served by:

• Large generic and specialty generic manufacturers across tablets, chewables/dispersibles, and pediatric suspensions
• Brand incumbents in markets where branded products still command differentiated pricing and prescribing habits
• Local market players producing authorized generic versions through distribution channels

Commercial implication Clinical activity is less about “who has a breakthrough” and more about “who can launch a well-tolerated, label-friendly, competitively priced product” with compliant manufacturing and acceptable taste/suspension stability profiles in pediatrics.

How big is the global market for amoxicillin clavulanate potassium and what drives volume?

Amoxicillin/clavulanate is a staple in outpatient and primary care for common bacterial infections, including:

• Acute bacterial sinusitis (where guidelines support)
• Otitis media
• Dental infections
• Skin and soft tissue infections
• Community-acquired infections requiring beta-lactam/beta-lactamase inhibitor coverage

Demand drivers

• High prevalence of targeted indications
• Persistent need for oral pediatric formulations
• Stewardship dynamics: use is influenced by local guideline adherence and antibiotic resistance patterns
• Competitive pricing due to widespread generic availability

Market structure

• Volume leadership: oral formulations in adult and pediatric use
• Pricing pressure: strong generic competition lowers unit economics
• Tender and reimbursement effects: major impact in EU and other government-led markets
• Formulation differentiation: taste, stability, dosing convenience, and pack economics

Projection view Long-term growth is usually modest in developed markets because co-amoxiclav is mature and generic. Growth tends to be pulled by:

• Pediatric population demand
• Emerging markets with improving access and prescribing infrastructure
• Shifts toward fixed-dose convenience packs

What is the amoxicillin clavulanate market outlook for 2026–2035?

Forecast direction

• Global volume growth: steady, but not explosive.
• Value growth: slower than volume due to pricing compression from generics and tendering.
• Substitution risk: substitution to other beta-lactam/beta-lactamase inhibitor options and cephalosporins can occur based on resistance and guideline changes.

Scenario logic for business planning

• Base case: continued generic market expansion, moderate price declines stabilize over time.
• Downside case: stronger reimbursement pressure and antibiotic stewardship reduce use frequency.
• Upside case: pediatric use expansion in high-growth markets and improved adherence through better formulations lift share for specific manufacturers.

When does amoxicillin clavulanate lose exclusivity in major markets?

For the active combination amoxicillin/clavulanate, key chemistry and basic combination rights are generally long expired across major jurisdictions. Commercial “exclusivity” today typically comes from:

• Formulation-specific patents (e.g., particular ratios, specific dosage forms, modified release, or pediatric-ready presentations)
• Process patents (manufacturing route claims that can delay certain generics)
• Data exclusivity only for particular line extensions (where applicable and still granted by regulation)
• Orphan/other exclusivity: generally not a driver for co-amoxiclav due to broad use

Practical consequence Market entry is often governed by:

• ANDA/para IV or market authorization pathways
• formulation/manufacturing IP barriers rather than “core” compound exclusivity

What patents protect amoxicillin clavulanate potassium in 2026?

Co-amoxiclav’s patent estate is typically narrow and line-extension focused:

• Oral dosage form patents: specific strength configurations, pediatric dosing systems, taste-masking, suspension stability
• Manufacturing/process patents: crystallization, drying, blending control, scale-up steps
• Packaging and administration patents: device-based claims (less frequent)
• Method-of-use patents: less common for off-patent core antibiotics, but can appear for specific regimens

Commercial takeaway For market entry and licensing, the question is usually not “is the active ingredient protected,” but “is the target product form and manufacturing method protected.”

What is the Orange Book status of amoxicillin clavulanate potassium (U.S.)?

Because amoxicillin/clavulanate is widely genericized, Orange Book coverage is characterized by:

• Multiple listed products with varying listed patents (often formulation-specific or process-related)
• Sparse remaining active brand exclusivities compared with newer therapeutics

How it affects entry

• Generic entry timing is typically tied to whether listed patents are still active for the exact formulation strength and dosage form.
• Patent challenges, if pursued, are usually targeted to specific listed claims rather than broad compound coverage.

What Paragraph IV challenges exist for amoxicillin clavulanate potassium?

Paragraph IV activity is generally limited for mature, heavily generic antibiotic combinations unless a manufacturer is:

• seeking entry for a specific strength/dosage form with a still-active formulation or process patent
• targeting a novel line extension

Business implication Co-amoxiclav tends to show incremental entry litigation, not high-profile nationwide compound patent fights.

What generic entry risks exist for amoxicillin clavulanate potassium?

Key entry risks are typically:

• Formulation patent “non-infringement” ambiguity: taste/stability and excipient system claims can complicate design-around
• Process/purity/polymorph-type constraints: manufacturing route changes can trigger infringement risk if claims are broad
• Label and pediatric dosing requirements: even when ANDA is available, label parity and pediatric adequacy can slow launch
• Supply chain and bioavailability consistency: suspension stability and particle size controls can create approvals or post-market change issues

How does amoxicillin clavulanate compare with competing antibiotics in cost and access?

Competitive set varies by market and guideline, but typically includes:

• Other beta-lactam/beta-lactamase inhibitors (e.g., ampicillin/sulbactam depending on form factor and region)
• Oral cephalosporins (for sinusitis/skin infections)
• Macrolides or doxycycline in penicillin-allergic or guideline-driven pathways (where appropriate)

Commercial reality

• Co-amoxiclav is usually advantaged on spectrum plus tolerability and guideline fit
• Price is the major differentiator where generics dominate

Which formulation patents are most likely to matter for amoxicillin clavulanate market access?

The highest likelihood claims (when present in the active set) cluster around:

• Ratio-specific amoxicillin:clavulanate formulations
• Pediatric suspensions (stability, reconstitution instructions, shelf life)
• Taste-masking and excipient composition
• Modified release or extended stability suspensions
• Manufacturing steps affecting consistent delivery of clavulanate (chemically labile)

Investor/litigation angle Formulation and process claims can create a longer tail than compound patents in mature antibiotics.

What manufacturing and IP barriers can delay amoxicillin clavulanate generic launches?

For co-amoxiclav, the common operational barriers are:

• Clavulanate stability during blending, drying, and shelf-life conditions
• Scale-up reproducibility for the same dissolution and bioequivalence profile
• Tight controls for particle size and uniformity in suspensions
• Regulatory changes requiring new stability data or manufacturing site updates

Result Even when patent barriers are low, operational hurdles can delay launch timing.

What regulatory milestones and FDA pathway considerations affect amoxicillin/clavulanate products?

U.S. products generally proceed via:

• ANDA pathways for generics and authorized generics
• 505(b)(2) only for specific line extensions where reliance on published data is available

Key regulatory considerations for co-amoxiclav line extensions:

• Bioequivalence study adequacy in the relevant population
• Stability data, especially for clavulanate-containing suspensions
• Labeling consistency for pediatric dosing and reconstitution

How does the clinical trial environment for amoxicillin clavulanate differ from newer antibacterial development?

Newer antibiotics run registrational trials aimed at specific resistances and harder-to-treat populations. Co-amoxiclav’s clinical activity is more:

• Label maintenance
• Formulation BE
• Population support (pediatrics, renal impairment)
• Access-driven development rather than novel efficacy expansion

Commercial consequence Co-amoxiclav market movement comes from pricing, supply, and formulation launches, not breakthrough clinical outcomes.

What is the litigation and settlement landscape for amoxicillin clavulanate?

Litigation exists but is usually:

• targeted to specific listed patents for specific dosage forms
• resolved via settlements that allow timed launches of generic versions

Expected posture

• Brand or patent holders press formulation/process claims
• Generics settle when infringement risk is meaningful but avoid long delays

Key Takeaways

• Amoxicillin/clavulanate’s clinical trial update is dominated by formulation, pediatric, and bioequivalence work, not new-mechanism Phase 3 programs.
• Market demand is steady and guideline-driven, with pediatric and outpatient infections as primary volume sources.
• Value growth is constrained by intense generic competition; differentiation is mostly formulation, labeling, and supply execution.
• Patent and exclusivity dynamics are typically line-extension focused (formulation/process) rather than core compound protection, driving incremental litigation and launch timing rather than major exclusivity events.
• The most material generic entry risks are formulation stability/purity/process claim scope and dosage-form-specific patent coverage.

FAQs

1. Which amoxicillin/clavulanate dosage forms have the biggest stability and formulation approval hurdles in generics?
2. How do pediatric suspension taste-masking and stability claims affect ANDA launch timing for amoxicillin/clavulanate?
3. What types of patents (process vs formulation vs method-of-use) most commonly remain active for co-amoxiclav products?
4. How do antibiotic stewardship and resistance trends change prescribing volume for amoxicillin/clavulanate by region?
5. What settlement structures are typical in late-stage disputes over amoxicillin/clavulanate listed patents?

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References (APA)
No citations were provided in the request, and no source material was supplied to support a fact-specific clinical trials, Orange Book status, patent estate, or litigation chronology for amoxicillin/clavulanate potassium.