TheraRadar
Data updated: May 26, 2026

VOQUEZNA TRIPLE PAK (amoxicillin)

First-in-Class Priority Review Fast Track
Infectious Disease Approved 2022-05-03

VOQUEZNA TRIPLE PAK is indicated for the treatment of Lower Respiratory Tract Infection; Acute Bacterial Otitis Media; Sinusitis; Skin and Skin Structure Infection; Urinary Tract Infection.

Source: FDA Label • PHATHOM
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How VOQUEZNA TRIPLE PAK Works

Voquezna Triple Pak utilizes three distinct mechanisms to treat *H. pylori*: 1. **Vonoprazan:** Inhibits the H+, K+-ATPase enzyme (the proton pump) at the secretory surface of gastric parietal cells in a potassium-competitive manner. This suppresses basal and stimulated gastric acid secretion, which increases gastric pH and enhances the stability and efficacy of the co-administered antibiotics. 2. **Amoxicillin:** A bactericidal antibiotic that inhibits the biosynthesis of cell wall peptidoglycan, leading to bacterial cell lysis. 3. **Clarithromycin:** A bacteriostatic macrolide that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of susceptible organisms.

Source: FDA Label
1
Indication
--
Phase 3 Trials
1
Priority Reviews
4
Years on Market

Details

Status
Prescription
First Approved
2022-05-03
Patent Cliff
2030

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE, TABLET, TABLET

Companies

PHATHOM
Active Ingredient: AMOXICILLIN , CLARITHROMYCIN , VONOPRAZAN FUMARATE

VOQUEZNA TRIPLE PAK Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2022 to 2025
Oct 2025 SUPPL
Label · Labeling
FDA Letter Label
Jun 2025 SUPPL
Label · Labeling
FDA Letter Label
Jun 2025 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label

What VOQUEZNA TRIPLE PAK Treats

5 indications

VOQUEZNA TRIPLE PAK is approved for 5 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Lower Respiratory Tract Infection
  • Acute Bacterial Otitis Media
  • Sinusitis
  • Skin and Skin Structure Infection
  • Urinary Tract Infection
Source: FDA Label

VOQUEZNA TRIPLE PAK Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

DALBAVANCIN HYDROCHLORIDE
Fresenius Kabi
2025 1 indic.
CONTEPO
MEITHEAL
2025 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to VOQUEZNA TRIPLE PAK

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AMOXICILLIN PEDIATRIC
AMOXICILLIN
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Teva
Shared indications:
Lower Respiratory Tract InfectionAcute Bacterial Otitis MediaSinusitis +2 more
AUGMENTIN '125'
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US ANTIBIOTICS
Shared indications:
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AUGMENTIN '250'
AMOXICILLIN
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US ANTIBIOTICS
Shared indications:
Lower Respiratory Tract InfectionAcute Bacterial Otitis MediaSinusitis +2 more
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Clinical Trial Registry

116 trials
Trial Sponsor ID Phase Status Title
NCT06921213 Cares-1 31732 Ph 2 recruiting Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis
NCT06823154 1000069700 Ph 1 active not recruiting The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department
NCT07275580 PRO-EXOD 69108723.1.0000.0068 Ph 4 not yet recruiting Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases
NCT06131021 PAAS Pro2023001347 4UH3DE031129-02 Ph 3 completed Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice
NCT06229288 CAPTAIN RC20_0015 Ph 3 recruiting Amoxicillin Alone Versus Amoxicillin/Clavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older, and Hospitalized in a Non-intensive Care Unit Ward
NCT07485010 FORMaT-EVOLVE FORMaT002 Ph 2 not yet recruiting Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial
NCT07457385 CONSISTENT Pending Ph 4 not yet recruiting Congenital Syphilis Treatment Trial (CONSISTENT) in Neonates
NCT06494072 PRO00046965 Ph 4 recruiting Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP
NCT05398679 OraPAT-IEGAMES OraPAT-IE GAMES Ph 4 recruiting Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
NCT06340724 KY20240123-08 Ph 3 completed Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H. Pylori Eradication
NCT07293910 Helicobacter Pylori Ph 2 recruiting Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection
NCT02701595 RODEO 2 Ph 3 completed Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus
NCT02281929 AntibioCor 2014_05 2014-002536-13, PHRC-2013-0552 Ph 3 completed Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone
NCT05309928 IRB-300008691 UAB Ph 1 completed Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy
NCT07242456 TV-HP TV-HP-2024-01 BCF-LX-XH-20221014-26 Ph 2, Ph 3 recruiting Head-to-head Study of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID vs. Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for H. Pylori Eradication
NCT06010719 AMOUR 23-39411 5R01HD111532 Ph 4 recruiting Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition
NCT04728516 2020SDUCRCA006 Ph 4 recruiting The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients
NCT05874544 rjhy20230001 Ph 4 completed Rescue Therapy for Helicobacter Pylori Infection
NCT02707042 160078 16-I-0078 Ph 1 completed Microbial, Immune, and Metabolic Perturbations by Antibiotics (MIME Study)
NCT03273296 1341/6.00.00/2017 Ph 4 completed Effect of Antibiotics on Gut Microbiome and Plasma Metabolome
NCT07068607 KY20252096-F-1 Ph 4 recruiting Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial
NCT06771492 ABBA 2024-515824-35 2024-515824-35-01 Ph 3 recruiting Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial
NCT06514274 KY20242226-C-1 Ph 4 completed Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication
NCT06168084 KY20232236-F-2 Ph 4 completed Helicobacter Rescue Therapy With Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
NCT05742568 KY20222310-C-1 Ph 4 completed Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology
NCT06523764 KY20242230-C-1 Ph 4 active not recruiting Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment
NCT03031210 BID pneumonia Ph 2, Ph 3 recruiting Twice Daily Treatment With Amoxicillin for Non-severe Community Acquired Pneumonia.
NCT06964334 vit D supplement h.pylori Ph 3 not yet recruiting The Effect of Vitamin D Supplement as Adjuvant Therapy in Eradication of Helicobacter Pylori Infection
NCT06877351 AMOXSYP 13246 Ph 3 active not recruiting Oral Amoxicillin Compared to Penicillin G Benzathine for the Treatment of Acquired Syphilis.
NCT05473234 results posted 22-36912 Ph 3 terminated Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria
NCT06576882 VOTE-HP 0306630 Ph 3 completed 7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication
NCT04070469 MAX-AMOX RBHP 2019 VIDAL (MAX-AMOX) 2019-002824-34 Ph 4 completed Plasma Concentrations of Amoxicillin Administered in High-doses During the First Week of Treatment (MAX-AMOX)
NCT06709196 REINFORCE 2024-514312-27-00 2024-514312-27-00 Ph 4 recruiting Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis
NCT05901051 rjyy20210815 Ph 4 completed High-dose Dual Therapy with Different Administration Frequencies
NCT06561698 rjhy20240814 Ph 4 recruiting High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection
NCT05649540 KY20221124-07 Ph 4 completed Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori
NCT06613776 CE032315 Ph 4 completed Evaluation of the Effect of Antibiotic Prophylaxis (2g Amoxicillin One Hour Before Surgery) on an Inflammatory Factor (PGE2) in Salivary Samples After Third Molars Surgery
NCT05302531 GRAAL 2021-001468-13 Ph 1 recruiting Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome
NCT06162949 0306381 Ph 3 completed Vonoprazan for Helicobacter Pylori Eradication in Adolescents
NCT05010304 results posted STU-2021-0517 Ph 4 completed Penicillin De-labeling in the Pediatric Primary Care Setting
NCT04552080 Syst AB + Sinus 01 Ph 4 recruiting The Effect of Systemic Antibiotics on Post-surgical Complications and Patient-centered Outcomes in Patients Undergoing Implant Surgery With Guided Bone Regeneration and Simultaneous Sinus Floor Elevation
NCT03060473 TREAT results posted 16-0323 Ph 3 terminated Treatment of ppROM With Erythromycin vs. Azithromycin Trial
NCT05469685 KY20220701-06 Ph 4 completed Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication
NCT03404804 OPEN results posted 1069530-3 Ph 4 completed Oral Challenge in the Pediatric ED
NCT06412640 KY20240419-15 Ph 4 not yet recruiting Optimization of Keverprazan-amoxicilli Dual Therapy for Helicobacter Pylori
NCT05431075 2022-SDU-QILU-G004 Ph 4 completed Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment of Different Tetracycline Doses
NCT06076694 results posted TNP-2198-06 Ph 2 completed Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants
NCT06076681 results posted TNP-2198-04 Ph 1, Ph 2 completed A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules
NCT05165212 STUDY00006018 Ph 4 withdrawn Primary Care Amoxicillin Challenge
NCT04198363 results posted Vonoprazan-3002 Ph 3 completed A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection

Showing 50 of 116 trials

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Key Completed Trials

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

VOQUEZNA TRIPLE PAK FDA Label Details

Indications & Usage

FDA Label (PDF)

VOQUEZNA TRIPLE PAK is indicated for the treatment of Lower Respiratory Tract Infection; Acute Bacterial Otitis Media; Sinusitis; Skin and Skin Structure Infection; Urinary Tract Infection.

View full patent landscape →
2 OB patents · 2 families · 136 international docs across 43 countries

VOQUEZNA TRIPLE PAK Patents & Exclusivity

Latest Patent: Aug 2030
Exclusivity: May 2032

Patents (2 active)

US9186411 Expires Aug 11, 2030
US7977488 Expires Apr 10, 2030

Exclusivity

NCE Until May 2027
GAIN Until May 2032
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for VOQUEZNA TRIPLE PAK

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2030
  • • 2 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA215152 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.