NDAORALTABLET, DELAYED RELEASE2 Generics Approved
Approved
Nov 2013
Lifecycle
LOE Approaching
Competitive Pressure
55/100
Clinical Trials
20
Data completeness
3/8 — Basic
NOXAFIL (posaconazole) by Merck & Co.. Approved for azole antifungal [epc]. First approved in 2013.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NOXAFIL (posaconazole) is an oral delayed-release azole antifungal tablet approved in 2013 for treating invasive fungal infections including aspergillosis and other mycoses. It works by inhibiting fungal cell wall synthesis through cytochrome P450 inhibition, providing broad-spectrum coverage in immunocompromised patients.
LOE Approaching2.7 years to LOE
Product is entering late-stage lifecycle with 2.8 years of exclusivity remaining, suggesting consolidation of commercial operations and shift toward transition planning and generic defense strategies.
Mechanism of Action
Pharmacologic Class:
Azole Antifungal
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
Started Feb 2022
40 enrolled
Invasive Fungal Infection
Pharmacokinetic of Posaconazole in Critically Ill Patients
Started Feb 2021
10 enrolled
Therapeutic Drug MonitoringCritical Illness
Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)
Started Jul 2020
31 enrolled
Invasive Aspergillosis
Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients
Started Mar 2020
249 enrolled
COVID-19 Respiratory InfectionAspergillosis
Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants
Started Aug 2019
100 enrolled
PosaconazolePharmacokineticsInvasive Candidiases+4 more
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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.