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 1h ago · AI intelligence enriched 1w 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. It works by inhibiting prostaglandin synthesis, a mechanism that facilitates ductal closure in infants who cannot tolerate or fail other interventions. This is a niche, hospital-based injectable indicated exclusively in the neonatal intensive care setting.
Peak5.7 years to LOE
Mature niche product with stable market position; small, focused commercial team given limited indication size and specialist hospital-based distribution.
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 stability within a specialized niche but limited growth opportunity; the product generates steady revenue from a loyal NICU customer base with minimal competitive pressure. This role is ideal for professionals seeking deep expertise in hospital-based pediatric/neonatal care and relationship-focused selling rather than high-volume market expansion.
Medical Science Liaison (Neonatal/Cardiology)Hospital Account Manager
Worked on NEOPROFEN at Recordati? Share your interview experience or compensation data (+7 days Pro)
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.