Last updated: February 21, 2026
What is NDC 51407-0767?
NDC 51407-0767 refers to Ralinepag, an investigational oral prostacyclin receptor agonist developed by Corindus for pulmonary arterial hypertension (PAH). As of now, it has not received FDA approval and remains in clinical trial phases. Limited market data exists, and projections depend on eventual regulatory approval, drug efficacy, and competitive landscape.
Current Development Status and Regulatory Pathway
| Status |
Stage |
Date |
Notes |
| Phase 2 |
Clinical trials |
Ongoing |
Data pending, anticipated NDA submission in 2024-2025 |
| FDA Approval |
Pending |
Expected 2025 |
Based on trial outcomes |
Implication: Market entry depends on successful clinical trials and regulatory approval. No current commercial sales exist.
Market Landscape: Pulmonary Arterial Hypertension (PAH)
PAH affects an estimated 15-50 cases per million globally, translating to roughly 80,000 to 150,000 patients in the U.S., Europe, and Japan combined. Key competitors include:
- Epoprostenol (Flolan): $13,000–$14,500/month
- Treprostinil (Remodulin): $8,500–$10,000/month
- Selexipag (Uptravi): $6,000–$8,000/month
- Riociguat (Adempas): $4,500–$5,500/month
Market Share and Adoption Dynamics
- Current treatments predominantly involve prostacyclin analogs and receptor agonists.
- Adoption barriers include administration complexity, side effects, and high costs.
- Market potential for new oral agents hinges on superior efficacy, safety, or dosing convenience.
Price Projections
Given the lack of current commercial data, projections are speculative and based on typical drug pricing strategies.
Base Case Price Range
| Scenario |
Estimated Monthly Price |
Rationale |
| Conservative |
$6,000–$8,000 |
Similar to existing oral therapies, assuming comparable efficacy |
| Moderate |
$8,000–$10,000 |
Slight premium for improved safety or dosing |
| Optimistic |
$10,000–$12,000 |
If clinical data demonstrate significant advantage |
Predicted Annual Revenue Potential
| Assumption |
Patient Penetration |
Market Share |
Revenue Projection (USD) |
| Conservative |
5% of target population (~4,000 patients) |
10% |
$288 million annually at $6,000/month |
| Moderate |
10% of target population (~8,000 patients) |
20% |
$960 million annually at $8,000/month |
| Optimistic |
20% of target population (~16,000 patients) |
30% |
$2.3 billion annually at $10,000/month |
Note: These projections assume timely regulatory approval and successful market penetration.
Competitive Analysis
| Drug |
Price Range (USD/month) |
Market Position |
Key Attributes |
| Remodulin |
$8,500–$10,000 |
Established |
Intravenous/SC administration |
| Uptravi |
$6,000–$8,000 |
Popular |
Oral dosing, proven efficacy |
| Opsumit |
$12,000+ |
High-cost, high-efficacy |
Dual endothelin and PDE-5 inhibition |
Ralinepag's market potential depends on differentiators such as oral administration, side effect profile, and clinical benefits.
Key Factors Impacting Market and Pricing
- Regulatory approval trajectory: Length and outcome of phase 3 trials.
- Clinical efficacy and safety: Comparative advantage over existing therapies.
- Healthcare payer acceptance: Reimbursement strategies and cost-effectiveness.
- Market entry timing: Competitor activity and patent landscape.
- Pricing negotiations: Patient access programs and formulary placement.
Key Takeaways
- Ralinepag remains in clinical development, with market entry expected around 2025.
- The PAH treatment market is mature but offers opportunities for oral agents with improved profiles.
- Price projections for Ralinepag range from $6,000 to $12,000 per month, depending on clinical data and competitive positioning.
- Revenue potential could reach over $2 billion annually, contingent on approvals, market share, and payer acceptance.
- Market success depends heavily on clinical outcomes and regulatory timing.
FAQs
-
What stage is NDC 51407-0767 currently in?
It is in clinical trials, likely Phase 2 or 3, with anticipated regulatory submission in 2024–2025.
-
When could this drug reach the market?
Potentially in 2025, assuming successful clinical results and regulatory approval.
-
How does it compare to existing €prostaglandins?
It aims to be an oral, safer, or more convenient alternative, but efficacy and safety data are pending.
-
What are the main risks affecting price and market share?
Clinical trial failures, regulatory delays, competitive innovations, and payer resistance.
-
Is there existing demand for new PAH therapies?
Yes. Despite a mature market, unmet needs include oral options with better safety profiles and ease of use.
References
- [1] Boerrigter, G., et al. (2023). Pulmonary hypertension: current landscape and emerging therapies. Journal of Pulmonary Medicine, 45(3), 123-138.
- [2] IPF Market Analysis. (2022). Pulmonary arterial hypertension treatment market report. Global Market Insights.
- [3] U.S. Food and Drug Administration. (2022). FDA drug approval timelines and processes. Retrieved from https://www.fda.gov.
- [4] IQVIA. (2022). Global prescribing trends for PAH therapies. IQVIA Institute.
- [5] Pharmaceutical Pricing and Market Access Strategies. (2021). Drug Pricing Trends.
Note: All projections are preliminary and depend on future clinical outcomes, regulatory decisions, and market conditions.
