NDAORALTABLET, EXTENDED RELEASE
Approved
Jan 2008
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
20
Data completeness
4/8 — Partial
MOXATAG (amoxicillin) by Pragma Bio is drug. First approved in 2008.
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MOXATAG is an extended-release oral tablet formulation of amoxicillin, a beta-lactam antibiotic that inhibits bacterial cell wall synthesis. It is indicated for treatment of bacterial infections susceptible to amoxicillin. The extended-release mechanism allows for reduced dosing frequency compared to immediate-release formulations.
LOE Approaching7mo to LOE
Product faces imminent generic erosion with 0.6 years of exclusivity remaining; commercial teams should anticipate workforce optimization and transition to defensive positioning or pipeline acceleration.
Mechanism of Action
drug. [see Clinical Pharmacology ()]
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Drug-Drug Interaction Between DW4421 and Amoxicillin/Clarithromycin
Started Feb 2026
36 enrolled
Healthy Adult Volunteers
A Study to Investigate the Effect of Linaprazan Glurate on the Pharmacokinetics of Amoxicillin
Started Nov 2025
12 enrolled
Drug InteractionGERD (Gastroesophageal Reflux Disease)Safety, and Tolerability
Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection
Started May 2023
700 enrolled
H.Pylori Infection
Drug Interaction Study Between Tegoprazan, Bismuth, Amoxicillin and Clarithromycin
Started Mar 2023
22 enrolled
Healthy
Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
Started Oct 2022
2,229 enrolled
Urinary Tract InfectionsCystitis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.