NDAORALTABLETPriority Review
Approved
Apr 2024
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
Priority Review
PIVYA (pivmecillinam) by Alembic is [see microbiology ( )] . First approved in 2024.
Drug data last refreshed 13h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PIVYA (pivmecillinam) is an oral beta-lactam antibiotic approved in April 2024 for bacterial infections. It is a mecillinam prodrug that works by inhibiting bacterial cell wall synthesis through penicillin-binding protein interaction. The drug represents an oral treatment option in the aminopenicillin class.
Growth
Early-stage growth product with moderate competitive pressure (30%) suggests active commercial build-out and expanding team opportunities in field and marketing roles.
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 offers early-career opportunities in a newly launched antibiotic brand entering growth phase under Alembic's portfolio. Roles focus on market establishment, clinician engagement, and field execution in the oral antibiotic space.
Brand Manager
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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.