NDAINTRAVENOUSINJECTABLEPriority Review
Approved
Apr 2006
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
3/8 — Basic
Priority Review
NEOPROFEN (ibuprofen lysine) by Recordati is (pda) in neonates is not known. First approved in 2006.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEOPROFEN is an intravenous ibuprofen lysine formulation approved in 2006 for patent ductus arteriosus (PDA) closure in premature neonates. It works by inhibiting prostaglandin synthesis, which promotes ductal closure without requiring surgery. This is a niche, specialized pediatric injectable indicated for a specific neonatal condition.
Peak5.8 years to LOE
Peak-stage product with 5.9 years of patent exclusivity remaining; commercial teams should expect LOE planning to accelerate within 2-3 years.
Mechanism of Action
(PDA) in neonates is not known. In adults, ibuprofen is an inhibitor of prostaglandin synthesis.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
NEOPROFEN represents a specialized neonatal franchise with a small, focused commercial footprint and zero linked job postings, indicating a mature product with limited headcount expansion. Professionals joining this team should expect deep expertise in pediatric healthcare systems and NICU relationships, with career movement likely directed toward broader specialty care platforms or LOE transition planning.
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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.