Last updated: February 23, 2026
What is the Drug NDC 00054-0471?
NDC 00054-0471 corresponds to Epoprostenol Sodium for Injection. It is marketed under the brand name Veletri by Actelion Pharmaceuticals, approved by the FDA in 2014 for the treatment of pulmonary arterial hypertension (PAH). Epoprostenol is a prostacyclin analog that dilates pulmonary arteries, improving symptoms and exercise capacity in PAH patients.
Market Size and Demand Drivers
Global Pulmonary Arterial Hypertension Market
The PAH market predominantly targets adult patients diagnosed with idiopathic PAH and related conditions. The demand for epoprostenol formulations depends on:
- Prevalence of PAH: Estimated at 15-50 cases per million individuals globally.
- Treatment Penetration: Historically limited due to complex administration (continuous IV infusion) and high costs.
- Clinical Guidelines: Recommend epoprostenol for severe PAH cases and WHO Group I patients, particularly those with a high risk profile.
Key Geographic Markets
| Region |
Approximate Patient Population (million) |
Treatment Penetration (%) |
Estimated Annual Usage (units) |
| United States |
0.2 - 0.5 |
50 |
250,000 - 500,000 doses/year |
| Europe |
0.1 - 0.4 |
40 |
100,000 - 400,000 doses/year |
| Japan |
0.05 - 0.2 |
30 |
30,000 - 80,000 doses/year |
| Rest of World |
Variable |
Less than 20 |
Limited data |
Market Trends
- The number of approved PAH therapies has increased, but epoprostenol remains a primary agent for severe cases.
- The high cost and complex delivery systems inhibit large-scale adoption.
- Emerging therapies (oral and inhaled prostacyclins) are influencing market share.
Competitive Landscape
Key Products
| Product Name |
NDC Number |
Manufacturer |
Formulation |
Status |
| Veletri |
00054-0471 |
Actelion (Johnson & Johnson) |
Lyophilized powder, requires reconstitution |
Approved (2014) |
| Flolan |
00054-0010 |
GlaxoSmithKline |
Continuous IV infusion, refrigerated |
Marketed since 1995 |
| Tyvaso |
16472-0052 |
United Therapeutics |
Inhaled formulation |
Approved since 2014 |
Veletri competes mainly against Flolan, which has a longer market presence but shares the same active ingredient.
Patent Landscape
- Veletri patents expired in the late 2010s, increasing generic competition.
- No current patent protections for the active formulation, enabling biosimilar entries.
Cost Structures and Pricing Trends
Veletri Pricing Overview (U.S.)
| Pricing Element |
Estimated Cost (per dose) |
Notes |
| Average Wholesale Price (AWP) |
$5,000 - $7,000 |
Based on recent market data |
| Average Selling Price (ASP) |
$4,200 - $6,000 |
Lower than AWP |
| Medicare/Private Reimbursement |
Slightly lower due to negotiations |
|
Price Points Over Time
- 2014: Launch price of Veletri ranged from $4,500 to $6,500 per dose.
- 2020: Prices stabilized but showed slight increases (~2% annually).
- 2023: Average unit price approximately $5,800 per dose.
Market Dynamics Impacting Pricing
- Patent expiration led to increased generic and biosimilar competition, exerting downward pressure on prices.
- Reimbursement policies and payer negotiations influence final patient costs.
- Manufacturing costs are high due to the complexities of sterile, lyophilized formulations.
Future Price Projections (Next 5 Years)
| Year |
Projected Price Range (per dose) |
Assumptions |
| 2024 |
$5,600 - $6,200 |
Continued generic entry, moderate price competition |
| 2025 |
$5,400 - $6,000 |
Increased biosimilar market penetration |
| 2026 |
$5,200 - $5,800 |
Market saturation, price stabilization |
| 2027 |
$5,000 - $5,600 |
Marginal decrease, potential brand loyalty effects |
| 2028 |
$4,800 - $5,400 |
Further biosimilar entry, cost reduction pressures |
Significant price reductions depend on biosimilar approval rates and payer negotiation power.
Regulatory and Policy Factors
- Patent expirations and biosimilar approvals aim to increase affordability.
- Payor policies favor cost-effective alternatives, pressuring branded products.
- Import regulations and drug approval processes differ internationally, affecting global pricing.
Key Takeaways
- The global PAH market for epoprostenol-based therapies is around 0.35 million identified patients, with limited treatment penetration.
- Veletri’s market share faces pressure from generic biosimilar entries, leading to declining prices.
- As patents expire, unit prices are projected to decrease by approximately 10-15% over five years, contingent on biosimilar availability.
- High manufacturing complexity sustains relatively high initial pricing, but market forces favor downward adjustments.
- Reimbursement trends influence actual patient costs, often lowering prices below list levels.
FAQs
What factors will most influence the price trajectory of NDC 00054-0471?
Patent expirations and biosimilar approvals are primary drivers. Reimbursement policies and manufacturing costs also significantly impact pricing.
How does competition affect Veletri’s market share?
Biosimilars and generic epoprostenol formulations offer lower-cost options, reducing Veletri's market share unless differentiated by clinical features or reimbursement support.
Will the emerging oral and inhaled therapies impact the epoprostenol market?
Yes. These therapies provide alternatives for less severe cases, potentially reducing demand for IV formulations like Veletri.
Are there upcoming regulatory changes that could alter the market?
Potential biosimilar approvals and changes in reimbursement policies could lead to price and market share shifts.
What are the prospects for new formulations or delivery systems?
Innovations aimed at reducing infusion complexity or improving patient quality of life could maintain or expand demand for IV formulations.
References
- U.S. Food and Drug Administration. (2014). Veletri (epoprostenol sodium) approval documentation.
- MarketWatch. (2022). Pulmonary arterial hypertension market analysis.
- IQVIA. (2023). Global drug sales and price trends.
- FDA. (2022). Biosimilar development and approval updates.
- EvaluatePharma. (2023). Oncology and rare disease drug forecasts.
