NDAINJECTIONINJECTABLEPriority Review
Approved
Oct 1981
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
3/8 — Basic
Priority Review
PROSTIN VR PEDIATRIC (alprostadil) by Pfizer is prostaglandin receptor agonists [moa]. First approved in 1981.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROSTIN VR PEDIATRIC (alprostadil) is a prostaglandin receptor agonist administered by injection to maintain patent ductus arteriosus (PDA) in neonates with congenital heart defects pending surgical intervention. It works by relaxing vascular smooth muscle and dilating blood vessels to keep the ductus arteriosus open, allowing adequate pulmonary and systemic blood flow in infants who would otherwise have inadequate oxygenation.
LOE Approaching
As a 40+ year old niche product approaching loss of exclusivity with moderate competitive pressure (30), the brand team is likely small and focused on retention strategies in specialized pediatric cardiology.
Mechanism of Action
Prostaglandin Receptor Agonists
Pharmacologic Class:
Prostaglandin Analog
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Alprostadil in Maculopathy Study (AIMS)
Started Jul 2006
37 enrolled
Macular Degeneration
Topical Alprostadil for Female Sexual Arousal Disorder
Started Sep 2004
300 enrolled
Sexual Dysfunction, Physiological
Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
Started Mar 2004
840 enrolled
Peripheral Arterial Occlusive Disease
Career Relevance
Working on PROSTIN VR PEDIATRIC offers deep expertise in niche pediatric cardiology and critical care, but limited career growth due to the mature, specialized nature of the product and approaching loss of exclusivity. Professionals on this team develop strong relationships with a small, highly specialized customer base and gain valuable experience in defending against generics in regulated pediatric markets.
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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.