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 19h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEOPROFEN (ibuprofen lysine) is an intravenous nonsteroidal anti-inflammatory drug approved in 2006 for closure of patent ductus arteriosus (PDA) in premature neonates. The drug works by inhibiting prostaglandin synthesis, though the exact mechanism in PDA closure is not fully characterized. It is the only IV NSAID indicated for this neonatal condition.
Peak5.4 years to LOE
Product is at peak lifecycle stage with no direct competitors, indicating stable niche market positioning and mature, lean commercial infrastructure.
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
Working on NEOPROFEN offers a stable, specialized career path in a niche market with monopoly-like positioning and zero linked job openings currently listed. The product's mature lifecycle and LOE timeline suggest roles focused on market maintenance, hospital formulary management, and managed care negotiation rather than launch activities or expansion.
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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.