Last updated: February 16, 2026
What is NDC 00093-8166?
NDC 00093-8166 is a medication listing in the National Drug Code (NDC) database. It corresponds to Epoprostenol (Flolan), a vasodilator used to treat pulmonary arterial hypertension (PAH). Its primary indication is improving exercise capacity and delaying disease progression in PAH patients.
Market Overview
Market Size and Demand
The global PAH market was valued at approximately USD 4.5 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 7% through 2030, reaching an estimated USD 8 billion. The growth is driven by increasing prevalence of pulmonary hypertension, aging populations, and expanding indications for PAH therapies.
Key Competitors
- Revatio (Sildenafil): Oral PDE5 inhibitor, generic options available.
- Tracleer (Bosentan): Endothelin receptor antagonist.
- Adempas (Riociguat): Soluble guanylate cyclase stimulator.
- Veletri (Epoprostenol): Similar formulation, marketed by Actelion.
- Flolan (Epoprostenol): Original formulation by GlaxoSmithKline, now produced by several manufacturers under licensing agreements.
Market Dynamics
- Pricing: Epoprostenol remains one of the more expensive PAH drugs, with annual treatment costs exceeding USD 100,000 per patient.
- Insurance Coverage: Most commercial and government insurers cover Epoprostenol due to its demonstrated efficacy, albeit with prior authorization.
- Regulatory Trends: Increasing approval of generics and biosimilars could impact prices over the next decade.
Price Analysis
Current Pricing Landscape
- Brand Name (Flolan): Average wholesale price (AWP) ranges from USD 2,000 to USD 2,500 per vial (100 mcg). Typical annual treatment costs can range from USD 200,000 to USD 300,000 per patient.
- Generic/Epoprostenol (Other formulations): Prices are roughly 20-30% lower due to competition but remain expensive.
Factors Influencing Price Trends
- Introduction of biosimilars or generic equivalents typically results in price erosion.
- Market entry of alternative therapies that demonstrate comparable efficacy can put downward pressure on prices.
- Cost-sharing policies and insurance negotiations impact actual payer payments versus list prices.
Price Projections (Next 5–10 Years)
| Year |
Estimated Price Range per Vial (USD) |
Comments |
| 2023 |
2,000 – 2,500 |
Current pricing, high due to specialty status |
| 2025 |
1,800 – 2,200 |
Slight decline expected due to introduction of biosimilars |
| 2027 |
1,600 – 2,000 |
Biosimilar market penetration increases |
| 2030 |
1,400 – 1,800 |
Price stabilization with intensified competition |
Note: The projections assume continued market volume and no major regulatory barriers to biosimilar entry.
Regulatory and Pricing Policies Impact
- U.S. Medicaid and other government programs negotiate significant discounts, reducing net prices.
- Federal legislation, such as the Inflation Reduction Act, could promote price caps on high-cost drugs.
- Patent expiration of branded formulations likely will accelerate generic/biosimilar market entry after 2024.
Key Takeaways
- Market size for PAH treatments continues to grow, driven by demographic and epidemiological trends.
- Price stability for Epoprostenol reflects its status as a critical therapy with limited alternatives.
- Competitive pressures from biosimilars and generics are forecasted to erode prices over the next decade.
- Regulatory considerations may influence pricing, with potential for discounts and negotiated rates in government-funded programs.
FAQs
1. How does NDC 00093-8166 compare to other PAH treatments in pricing?
Epoprostenol is among the highest-cost PAH drugs. Oral medications like sildenafil (Revatio) generally cost less annually, while intravenous therapies like Epoprostenol are more expensive.
2. Are biosimilars available for NDC 00093-8166?
As of 2023, no biosimilars have been approved in the U.S. for Epoprostenol. The market may see biosimilar entry post-2024 after patent expiration and regulatory review.
3. What factors could accelerate the price decline?
Introduction of biosimilars, increased competition, policy measures controlling drug prices, and shifts to alternative therapies can accelerate downward pricing trends.
4. How does insurance coverage influence actual patient costs?
Insurance plans typically negotiate discounts; patients may face copays or coinsurance. Government programs like Medicaid often secure significant price reductions.
5. Will new formulations or delivery methods affect pricing?
Yes, innovations such as inhaled or oral formulations could alter market dynamics, potentially lowering costs or expanding access, but currently, Epoprostenol remains delivered via continuous infusion.
Citations
[1] "Pulmonary Arterial Hypertension Market Size, Share & Trends Analysis Report," Grand View Research, 2022.
[2] "U.S. Patents and Exclusivity Data for Epoprostenol," U.S. Patent and Trademark Office, 2022.
[3] "Global PAH Market Forecast," IQVIA, 2023.
[4] "Medicare & Medicaid Drug Pricing Data," CMS, 2023.
