NEOPROFEN (ibuprofen lysine) · RECORDATI RARE
NeoProfen is a nonsteroidal anti-inflammatory drug (NSAID) indicated to close a clinically significant patent ductus arteriosus (PDA) in premature neonates weighing between 500 and 1500 g who are no more than 32 weeks gestational age. It is intended for use when usual medical management (e.g., fluid restriction, diuretics, and respiratory support) is ineffective. Because the consequences of treatment beyond 8 weeks have not been evaluated, NeoProfen should be reserved for infants showing clear evidence of a clinically significant PDA.
How NEOPROFEN Works
The exact mechanism by which ibuprofen causes closure of a patent ductus arteriosus (PDA) in neonates is unknown. In adults, ibuprofen is an inhibitor of prostaglandin synthesis; this action is believed to be the process that leads to the closure of the PDA in infants.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2006-04-13
- Patent Cliff
- 2032
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
NEOPROFEN Approval History
What NEOPROFEN Treats
1 indicationsNEOPROFEN is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Patent Ductus Arteriosus
Drugs Similar to NEOPROFEN
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
RECORDATI RARE's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03497715 | NL1401 | Ph 1 | terminated | Gamma Scintigraphy Study to Investigate Tablet Disintegration in Healthy Volunteers. |
| NCT02974361 | OAT-01 | Ph 1 | completed | Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen |
| NCT02452450 | NL1307 | Ph 1 | completed | Ibuprofen and Paracetamol Pharmacokinetic Study |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NEOPROFEN FDA Label Details
Indications & Usage
FDA Label (PDF)NeoProfen is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA. NeoProfen is a nonsteroidal anti-inflammat...
NEOPROFEN Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for NEOPROFEN
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 1 active patents
Trial Analysis
- • 3 total trials
- • Stage: Declining
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment