Last updated: August 4, 2025
Introduction
The drug identified by NDC (National Drug Code) 00591-2882 refers to Epoprostenol Injection, a potent vasodilator primarily used to treat pulmonary arterial hypertension (PAH). Its unique pharmacological profile makes it a cornerstone therapy, often considered for severe cases of PAH. As this medication commands a significant place in specialty pharmaceuticals, understanding its market dynamics and pricing trajectory is vital for stakeholders from payers to manufacturers.
This analysis synthesizes current market data, competitive landscape, regulatory environment, and pricing trends to offer comprehensive insights into the future of NDC 00591-2882.
Product Overview
Epoprostenol Injection is marketed under the brand name Flolan by Gilead Sciences and as Veletri by Actelion Pharmaceuticals (a Janssen company). Noted for its short half-life necessitating continuous IV infusion, the drug’s complexity influences manufacturing costs, administration logistics, and, consequently, its pricing model.
Regulatory and Commercial Status
- FDA Approval: Approved for the treatment of PAH.
- Formulation & Availability: Both branded and compounded formulations exist, with compounded versions available through specialty pharmacies, impacting pricing and competition.
- Market Exclusivity: Brand patents and exclusivities remain critical, with some biosimilar development potential emerging, although none have yet reached U.S. markets.
Market Landscape
Market Size and Patient Demographics
- The global PAH market is projected to reach $3 billion by 2027 [1].
- The U.S. constitutes the largest market, with an estimated 15,000–20,000 patients receiving therapy at any given time.
- Epoprostenol remains an essential therapy for WHO Group 1 PAH, especially in severe cases and WHO functional class III-IV patients.
Competitor and Alternative Therapies
While epoprostenol is a mainstay, other agents targeting PAH include:
- endothelin receptor antagonists (ERAs): Ambrisentan, Bosentan.
- Phosphodiesterase-5 inhibitors (PDE5i): Sildenafil, Tadalafil.
- Soluble Guanylate Cyclase Agonists: Riociguat.
- Prostacyclin analogs (e.g., Treprostinil, Selexipag).
The choice depends on disease severity, patient response, and route of administration. Epoprostenol’s intravenous delivery remains unmatched for the most advanced cases, securing its niche despite the emergence of inhaled and oral alternatives.
Market Drivers and Barriers
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Drivers:
- Rising PAH prevalence.
- Increasing awareness and earlier diagnosis.
- The drug’s proven efficacy in severe cases.
- Advocacy for late-stage therapy options.
-
Barriers:
- High costs associated with continuous infusion.
- Complexity of administration and side-effect management.
- Availability of alternative therapies with easier administration routes.
Pricing Trends and Projections
Current Pricing Landscape
As of late 2022, the wholesale acquisition cost (WAC) for brand-name epoprostenol (e.g., Flolan) hovers between $46,000 and $60,000 per year per patient, depending on dosing and pharmacy factors [2]. Veletri’s pricing is comparable, with minor variations.
- Generic/Compounded Formulations: Typically priced lower but face regulatory and safety concerns, impacting market share.
- Reimbursement Dynamics: Medicare, Medicaid, and private insurers often negotiate rebates, influencing actual expenditure.
Price Drivers
- Manufacturing Complexity: The peptide’s stability and the need for cold-chain logistics sustain high manufacturing costs.
- Regulatory Environment: Patent protections and exclusivity maintain pricing power.
- Market Competition: Limited generic entry due to patent barriers; biosimilars are under development but yet to impact pricing.
Future Price Trajectory (2023-2030)
Based on current trends, the following projections are anticipated:
| Year |
Expected Price Range |
Key Factors Influencing Price |
| 2023–2025 |
$45,000 – $65,000 |
Stable patent protection; limited biosimilar entry; inflationary pressures |
| 2026–2028 |
$43,000 – $60,000 |
Potential biosimilar approvals; increased competition; healthcare policy shifts |
| 2029–2030 |
$40,000 – $55,000 |
Biosimilar adoption; enhanced manufacturing efficiencies; payer negotiations |
Impact of Biosimilars and Pipeline Developments
While biosimilars for epoprostenol are not yet on the market, their probable introduction around 2028-2030 could provoke 15–30% price reductions due to heightened competition. Efforts to develop next-generation prostacyclin pathway drugs—such as oral prostacyclin receptor agonists—may also influence demand, but their full market impact remains uncertain for the near term.
Regulatory and Market Trends Impacting Price and Market Dynamics
- Enhanced Guidelines: Evolving clinical guidelines favoring early combination therapy may shift resource utilization.
- Reimbursement Policies: Payer pressure for cost containment and value-based pricing could moderate future prices.
- Innovation Incentives: Patent extensions or orphan-drug designations may temporarily sustain high pricing.
Conclusions
The market for NDC 00591-2882 (Epoprostenol Injection) is characterized by high clinical value, limited competition, and substantial price resilience. While biosimilar and alternative therapies threaten to exert downward pressure starting in the late 2020s, current trends suggest prices will remain relatively stable through 2025, with moderated declines anticipated thereafter.
Stakeholders should monitor biosimilar regulatory progress, reimbursement landscape shifts, and innovative therapeutic pipelines to refine future pricing assumptions and investment strategies.
Key Takeaways
- Epoprostenol remains a critical therapy for severe PAH, supported by high clinician reliance and limited alternatives for specific patients.
- Current pricing sustains at approximately $45,000–$65,000 annually per patient, driven by manufacturing complexity, patent exclusivities, and market demand.
- The introduction of biosimilars around 2028-2030 could lead to significant reductions but will depend on regulatory approvals and market acceptance.
- Healthcare policy trends emphasizing value-based care may influence future reimbursement rates, maintaining prices within a controlled range.
- Continued innovation and regulatory developments are pivotal in shaping the pricing landscape for NDC 00591-2882.
FAQs
1. What is the primary therapeutic indication for NDC 00591-2882?
Epoprostenol Injection is primarily indicated for the treatment of pulmonary arterial hypertension to improve exercise capacity and hemodynamics in patients with severe disease.
2. Are biosimilars expected to impact the pricing of epoprostenol?
Yes. Biosimilars, expected to emerge around 2028-2030, could lower prices significantly due to increased competition, but their impact depends on regulatory approval and market acceptance.
3. How does the delivery method influence the drug’s market and price?
Epoprostenol requires continuous IV infusion, demanding specialized administration systems, which add logistical and cost burdens, sustaining higher prices relative to oral or inhaled alternatives.
4. What factors will most affect the future pricing of this drug?
Regulatory developments, patent status, biosimilar entry, healthcare policies, and advances in alternative therapies will most influence future prices.
5. Is there potential for cost reduction through compounded formulations?
Compounded versions are generally less expensive but pose safety and consistency concerns. Regulatory and safety considerations may limit their widespread use, thus not significantly impacting branded drug pricing.
References
[1] Grand View Research, “Pulmonary Arterial Hypertension Market Size, Share & Trends Analysis,” 2022.
[2] GoodRx, “Epoprostenol Pricing and Cost Insights,” 2022.
