PIVYA
Growthpivmecillinam
NDAORALTABLETPriority Review
Approved
Apr 2024
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
Priority Review
PIVYA (pivmecillinam) is [see microbiology ( )] . First approved in 2024.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PIVYA (pivmecillinam) is an oral beta-lactam antibiotic approved in April 2024 for the treatment of urinary tract infections (UTIs). It is a mecillinam prodrug that inhibits bacterial cell wall biosynthesis. Patients with uncomplicated and complicated UTIs represent the primary target population.
Growth
As a newly launched product in the growth phase with moderate competitive pressure (30), the brand team will focus on market penetration and establishing clinical adoption against entrenched competitors.
Mechanism of Action
[see Microbiology ( )] .
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Clinical Trial of Pivmecillinam Hydrochloride Tablets in the Treatment of Uncomplicated Urinary Tract Infection
Started Sep 2022
299 enrolled
Uncomplicated Urinary Tract Infection
Career Relevance
PIVYA represents a launch-phase opportunity in infectious disease with moderate commercial intensity given the crowded UTI market and LOE-approaching competitors. Roles will focus on driving formulary adoption, building clinical evidence vs. fluoroquinolones, and capturing market share from legacy agents during the critical first 18-24 months.
Brand Manager
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.