CLINICAL TRIALS PROFILE FOR AMOXICILLIN AND CLAVULANATE POTASSIUM

All Clinical Trials for Amoxicillin And 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.
NCT00249210 ↗	A Study of the Safety and Effectiveness of Levofloxacin Compared With Amoxicillin/Clavulanate Potassium in the Treatment of Adults With Rapid Onset of Severe Inflammation/Infection of the Sinuses	Completed	PriCara, Unit of Ortho-McNeil, Inc.	Phase 3	1993-08-01	The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with amoxicillin/clavulanate potassium in the treatment of adults with rapid onset of severe inflammation/infection of the sinuses.

Clinical Trial Conditions for Amoxicillin And Clavulanate Potassium

Condition Name

Condition Name for Amoxicillin And Clavulanate Potassium
Intervention	Trials
Sinusitis	4
Unspecified Adult Solid Tumor, Protocol Specific	2
Pneumonia, Bacterial	2
Acute Otitis Media	2

Condition MeSH

Condition MeSH for Amoxicillin And Clavulanate Potassium
Intervention	Trials
Sinusitis	5
Pneumonia	2
Neutropenia	2
Lymphoma	2

Clinical Trial Locations for Amoxicillin And Clavulanate Potassium

Trials by Country

Trials by Country for Amoxicillin And Clavulanate Potassium
Location	Trials
United States	27
Poland	4
United Kingdom	3
Mexico	3
Canada	3

Trials by US State

Trials by US State for Amoxicillin And Clavulanate Potassium
Location	Trials
Pennsylvania	5
California	4
Ohio	3
Arkansas	3
Utah	2

Clinical Trial Progress for Amoxicillin And Clavulanate Potassium

Clinical Trial Phase

Clinical Trial Phase for Amoxicillin And Clavulanate Potassium
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	2
Phase 3	7

Clinical Trial Status

Clinical Trial Status for Amoxicillin And Clavulanate Potassium
Clinical Trial Phase	Trials
Completed	11
Terminated	4
Unknown status	2

Clinical Trial Sponsors for Amoxicillin And Clavulanate Potassium

Sponsor Name

Sponsor Name for Amoxicillin And Clavulanate Potassium
Sponsor	Trials
Pfizer	3
University of Pittsburgh	2
Teva Pharmaceuticals USA	2

Sponsor Type

Sponsor Type for Amoxicillin And Clavulanate Potassium
Sponsor	Trials
Other	16
Industry	10

Amoxicillin and Clavulanate Potassium Clinical Trials Update, Market Analysis, and Launch-Exclusivity Projection

Last updated: May 21, 2026

Amoxicillin and clavulanate potassium is an established, off-patent small-molecule antibiotic combination with broad, multi-source manufacturing and limited remaining IP-driven exclusivity in most markets. Clinical-trials activity in recent years skews toward new dosing regimens, pediatric use, local/regional formulations, and trial renewals or post-authorization studies rather than patent-protected, brand-new chemical entities.

Because amoxicillin-clavulanate is widely approved and genericized, market upside is driven primarily by (i) antibiotic stewardship-driven substitution patterns, (ii) hospital formularies and bundled purchasing, (iii) safety and tolerability perception (GI adverse events), and (iv) expansion of guideline-concordant indications in target geographies. Projections should be framed around volume stability, price compression, and incremental share gains for higher-quality supply chains and differentiated formulations (dose ratios, pediatric strengths, and lower-dose clavulanate strategies where available).

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What clinical trials are ongoing or recently completed for amoxicillin and clavulanate potassium?

What trial types are most common for this drug combination?

Recent clinical-trials for amoxicillin-clavulanate generally fall into four buckets:

1. Pediatric and age-stratified studies

   • Weight-based dosing verification
   • Palatability and suspension acceptability endpoints
   • Pharmacokinetic (PK) bridging from older pediatric cohorts

2. Alternative regimens and dosing optimization

   • Short-course versus longer-course comparisons
   • Dose-frequency modifications (where clinically justified by site infections)
   • Extended-release is uncommon in the molecule, but regimen optimization is persistent

3. Comparative effectiveness trials vs. other antibiotics

   • Beta-lactam comparisons (e.g., cephalosporins, penicillin alternatives)
   • Step-down strategies (IV-to-oral transitions)
   • Resistance-context comparative endpoints (clinical cure and microbiologic eradication)

4. Safety-focused and real-world/post-authorization commitments

   • Adverse event characterization
   • Subgroup analyses (history of hypersensitivity, GI intolerance)
   • Pharmacovigilance driven analyses

How to read the “clinical trials update” signal for a mature antibiotic?

For amoxicillin-clavulanate, “clinical trials activity” rarely indicates a near-term IP tail. Trial pipelines are typically designed to support:

• label refinements for specific populations
• formulation suitability (suspensions, chewables, tablets)
• local regulatory requirements in high-volume markets
• stewardship-aligned indication positioning

What endpoints matter most in these trials?

Across comparative and optimization studies, the featured endpoints usually include:

• clinical cure/improvement at test-of-cure
• microbiologic eradication in culture-positive subpopulations
• time to symptom resolution
• safety: diarrhea, nausea, vomiting, rash, and serious hypersensitivity signals
• adherence and tolerability in pediatrics

Net implication: trials most often support incremental labeling and market uptake, not blockbuster growth.

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How big is the market for amoxicillin and clavulanate potassium and where is demand coming from?

What demand drivers dominate?

Demand is structurally tied to infection incidence and guideline adherence in high-prescribing settings:

• Upper respiratory tract infections where beta-lactam therapy is recommended
• Acute bacterial sinusitis and related ENT infections
• Otitis media in pediatric markets
• Lower respiratory tract infections in appropriate clinical contexts
• Dental and skin/soft tissue infections in settings with recommended use

Where does share typically shift?

Share shifts occur when:

• local formularies prefer certain dose strengths or packaging
• pediatric acceptance improves (better-tasting suspensions)
• procurement favors lower unit costs or reliable supply
• stewardship programs push clinicians toward narrower or guideline-concordant agents

What is the “pricing reality” for projection modeling?

For established, multi-source antibiotics:

• unit price declines with generic competition
• revenue growth is constrained unless volume expands or differentiated products win formulary positions
• gross margin improves only through supply-chain scale and portfolio mix (higher-value package sizes, pediatric-focused SKUs)

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When does amoxicillin and clavulanate potassium lose exclusivity, and is there any remaining patent life?

Does the active ingredient combination still have meaningful patent exclusivity?

In general, amoxicillin-clavulanate combination IP from earlier periods is largely expired or near-expired across key jurisdictions, leaving:

• minimal brand-driven exclusivity
• residual protection (if any) tied to specific formulation, method-of-use, or manufacturing processes
• local market authorizations that can block direct equivalents only in narrow circumstances

How to think about “exclusivity” for a generic-heavy antibiotic

For amoxicillin-clavulanate, the practical exclusivity question is less “brand exclusivity end date” and more:

• whether any remaining patents cover a specific dose ratio, formulation, manufacturing method, or use that could delay generic substitution for that specific product line

Net implication: competitive entry timing is usually governed by:

• product-specific Orange Book listings (if any)
• regulatory eligibility and bioequivalence readiness
• any relevant litigation settlements tied to particular NDCs

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What patents protect amoxicillin and clavulanate potassium in the US Orange Book, and what is their strength?

Typical US patent categories seen for this drug class

For an established combination antibiotic, surviving patent coverage, when present, generally clusters around:

• formulation (particle size, excipient system, coating approaches for taste masking)
• method of manufacture
• method of use (narrow clinical protocols, pediatric dosing regimens, or specific indications)
• medical device or combination products (less common for this specific active ingredient)

How many patent families usually matter commercially?

Commercial relevance is usually limited to a small number of product-specific listings for particular NDCs. Most generic entry is not blocked by broad combination patents because those are typically expired.

How to assess “strength” for investor or litigation posture

Strength indicators:

• claims that cover a manufacturing approach that generic applicants cannot avoid
• active, asserted patents with recent litigation or licensing activity
• narrow claims that still map cleanly to an existing brand product’s formulation

For an off-patent, multi-source antibiotic, “strength” most often resides in packaging/formulation patents that apply only to a subset of marketed SKUs.

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Which companies are challenging amoxicillin and clavulanate potassium with Paragraph IV filings?

Paragraph IV risk profile for mature antibiotics

For amoxicillin-clavulanate, Paragraph IV filings are usually:

• more common around specific brand NDCs that still have Orange Book-listed patents
• tied to formulation or manufacturing-method claims rather than the core drug combination

Litigation outcomes tend to be:

• early settlements where the brand’s remaining listings still map to a core formulation
• design-around via alternate excipient systems or manufacturing process changes
• dismissal if patents are found not infringed by the generic’s proposed product profile

Net implication: Paragraph IV risk is NDC-specific and often concentrated in particular strengths (e.g., pediatric suspensions) where formulation differentiation is greatest.

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What generic entry risks exist for amoxicillin and clavulanate potassium formulations?

Where generic differentiation actually matters

Generic risk is mainly:

• bioequivalence and taste/acceptability in pediatric suspensions
• stability and shelf-life for liquid formulations
• excipient compatibility that impacts GI tolerability perception

What manufacturing/IP barriers commonly slow entry?

Common barriers (in the patent sense) include:

• formulation-related claims tied to specific excipient concentrations or coating/taste-masking techniques
• manufacturing-method claims tied to granulation or drying steps

For off-patent products, the barriers are usually not chemical synthesis patents, but product form and process claims.

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How does amoxicillin and clavulanate potassium compare with alternatives in the same therapeutic space?

Key competitive alternatives

In practice, competing therapies include:

• other beta-lactams (penicillins and cephalosporins)
• macrolides or respiratory fluoroquinolones in select contexts
• clindamycin or doxycycline for certain skin/soft tissue indications
• combination or narrow alternatives depending on guideline and resistance patterns

Where amoxicillin-clavulanate typically wins

• guideline-concordant coverage for common beta-lactamase producing pathogens
• oral step-down practicality
• long-standing clinician familiarity and lab familiarity in dosing

Where it loses

• GI tolerability concerns relative to some narrow alternatives
• stewardship pressure that can shift clinicians toward narrower agents when feasible
• procurement-driven substitution

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What regulatory status does amoxicillin and clavulanate potassium have, and how does that affect market access?

FDA pathways and market structure impact

Most market access for this drug is achieved through:

• ANDAs for generics
• reliance on established safety and efficacy profiles for already widely approved formulations
• bioequivalence requirements rather than clinical effectiveness trials

Why formulation matters for regulatory access

Liquid formulations, pediatric strengths, and specialized dose ratios can require:

• robust stability packages
• bioequivalence studies or bridging strategies depending on product type

Net implication: regulatory friction can exist at the NDC level even when the active ingredient is fully generic.

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Market projection for amoxicillin and clavulanate potassium through the next 5–10 years: what changes matter?

Base-case projection framework (high level)

For a mature, genericized antibiotic combination, projections should be built around:

1. Volume: stability with potential modest growth from pediatric and ENT burden where prescribing remains guideline-aligned
2. Price: continued erosion from multi-source competition
3. Mix: differentiation via pediatric-friendly formulations and pack sizes
4. Policy: stewardship guidelines and reimbursement nudges
5. Supply: capacity reliability, quality outages, and sourcing constraints

What “upside” looks like

Upside scenarios typically require one or more:

• faster substitution adoption for a differentiated formulation (improved tolerability, better palatability)
• successful label refinement in a high-volume subgroup that expands prescriber comfort
• sustained hospital formulary positioning for reliable supply

What “downside” looks like

Downside scenarios include:

• stewardship-driven reductions in broad prescribing for certain infection categories
• aggressive formulary substitution to alternatives with better tolerability profiles or narrower spectrum
• pricing pressure from additional generic entrants

Net projection stance: the category is likely to deliver low-to-moderate nominal revenue growth driven by mix and volume, with profit pools concentrated in supply-chain leaders and differentiated NDCs rather than “brand-like” exclusivity.

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Key takeaways

• Amoxicillin and clavulanate potassium remains clinically entrenched, with trial activity focused on pediatric use, regimen optimization, and formulation/regulatory compliance rather than new protected mechanisms.
• Exclusivity is primarily product- or NDC-specific, with the core combination broadly off-patent.
• Market outcomes are driven by procurement and stewardship rather than patent-driven scarcity.
• Five-to-ten-year performance is more likely to depend on formulation mix, supply reliability, and formulary access than on new clinical efficacy breakthroughs.

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FAQs

1) Are there new clinical indications for amoxicillin and clavulanate potassium in recent trial programs?
Recent activity is typically label-refinement and subgroup-focused rather than new broad indications.

2) Do pediatric suspension formulations face unique development or regulatory hurdles?
Yes, formulation stability, palatability, and bioequivalence packaging drive much of the work.

3) Can Paragraph IV challenges still block generic entry for amoxicillin-clavulanate?
Only where specific NDCs retain Orange Book-listed patents that map to the brand product’s formulation or method.

4) How does antibiotic stewardship change demand for amoxicillin-clavulanate?
Stewardship can shift utilization toward narrower agents when clinically feasible, limiting category growth.

5) What commercial levers matter most for revenue projection in this category?
Volume stability, unit price decline, and differentiated formulation mix (dose strengths, pediatric SKUs, and reliable supply) are the main levers.

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References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. U.S. National Library of Medicine. ClinicalTrials.gov.
3. Centers for Disease Control and Prevention. Antibiotic Use and Stewardship resources for outpatient and inpatient settings.