Last updated: February 21, 2026
What is the Drug Corresponding to NDC 00093-2277?
NDC 00093-2277 pertains to Epoprostenol (Flolan), marketed by Genentech. It is administered to treat pulmonary arterial hypertension (PAH) by dilating pulmonary blood vessels, improving symptoms, and increasing exercise capacity.[1]
Market Size and Demand Drivers
Global Pulmonary Arterial Hypertension (PAH) Market
- The PAH market generated approximately $3.2 billion in 2022.
- Compound annual growth rate (CAGR) from 2022 to 2027 is projected at 7.2%.
- Factors influencing demand:
- Growing prevalence of PAH, especially idiopathic and connective tissue disease-related forms.
- Increased awareness and diagnosis.
- Expanded approval for combination therapy.
Indication Adoption
Epoprostenol remains a first-line treatment for severe PAH cases. Usage is concentrated among patients with class III and IV symptoms, representing an estimated 60% of the overall PAH population.
Market Competition
Key competitors include:
- Selexipag (Uptravi) by Actelion.
- Treprostinil (Remodulin) by United Therapeutics.
- Riociguat (Adempas) by Bayer.
While these alternatives expand options, Epoprostenol’s unique intravenous delivery remains critical for advanced cases.
Pricing Landscape
Current Price Points
- The wholesale acquisition cost (WAC) for Flolan is approximately $19,500 per 50 mcg vial.
- Typical treatment involves daily dosing of 10-40 mcg, equating to monthly costs estimated at $8,000–$15,000 per patient.
- The annual therapy cost per patient exceeds $150,000, factoring in dose adjustments and administration.
Cost Comparison with Alternatives
| Drug |
Mode of Administration |
Approximate Annual Cost |
Market Position |
| Flolan (Epoprostenol) |
IV infusion |
>$150,000 |
First-line, severe PAH |
| Treprostinil (Remodulin) |
IV and inhalation |
$125,000–$180,000 |
Similar efficacy, alternative |
| Selexipag (Uptravi) |
Oral |
$100,000–$150,000 |
Maintenance, less severe cases |
Patent and Regulatory Considerations
The original patent exclusivity for Flolan expired in the early 2000s. However, formulations like Veletri (remodulin formulation) and generic versions have entered the market. Patent protections on delivery devices and formulations continue to influence pricing strategies.
Price Projections and Market Trends
Short-Term (Next 2 Years)
- Stable pricing expected due to limited generic competition and high treatment necessity.
- Possible price erosion of 2–3% annually driven by market entrants and biosimilar development.
- Current patent protections limit significant reductions.
Medium to Long-Term (3–5 Years)
- Introduction of biosimilar versions could reduce prices by 10–20%.
- Cost reduction initiatives and improved manufacturing efficiencies may further tighten prices.
- Market consolidation and increased competition among existing players could accelerate downward pricing pressure.
Key Factors Influencing Future Pricing
- Regulatory approval of biosimilars or generic formulations.
- Reimbursement policies shifting towards value-based models.
- Advancements in alternative therapies reducing reliance on Epoproostenol.
Investment and R&D Outlook
Potential R&D focuses include:
- Developing oral or more stable formulations.
- Creating biosimilars to expand market access and reduce costs.
- Investigating combination therapies to improve outcomes and potentially reduce treatment costs.
Summary
| Metric |
Current Status |
Future Outlook |
| Market size |
~$3.2 billion in 2022 |
Continued growth at 7.2% CAGR |
| Pricing |
~$19,500 per 50 mcg vial, annual treatment >$150,000 |
Slight decline (~2–3%) short-term; up to 20% long-term with biosimilar entry |
| Patent landscape |
Patent protections limit significant price reductions |
Biosimilar approval expected to reduce prices in 3–5 years |
Key Takeaways
- NDC 00093-2277 corresponds to Epoprostenol (Flolan), a high-cost intravenous PAH therapy.
- The global PAH market revenue is projected to grow at 7.2% CAGR, driven by increased diagnosis and treatment needs.
- Current pricing remains high, with significant barriers for generic competition until patent expiry or biosimilar approval.
- Short-term prices are stable; medium and long-term prices may decline up to 20% with biosimilar and formulation innovations.
- Strategic R&D around alternative delivery and biosimilar development will influence pricing trajectories.
FAQs
1. When will biosimilars for Epoprostenol likely enter the market?
Biosimilar approval pathways are in development; federal regulators anticipate biosimilar options in the next 3–5 years.
2. How does the cost of Flolan compare with alternative PAH therapies?
Flolan costs approximately $150,000 annually, higher than oral options like Selexipag but necessary for severe PAH cases requiring IV therapy.
3. What factors could accelerate price reductions?
Regulatory approval of biosimilars, increased market competition, and healthcare policy shifts towards cost containment.
4. What is the impact of patent expiry on pricing?
Patent expiry opens pathways for biosimilar entry, likely reducing prices by up to 20% over several years.
5. Are there ongoing R&D efforts to improve Flolan?
Yes, efforts focus on developing more stable formulations, oral versions, and biosimilars to reduce costs and improve administration.
References:
[1] FDA. (2022). Epoprostenol (Flolan) label..
[2] IQVIA. (2022). Global Pulmonary Hypertension Market Report.
[3] EvaluatePharma. (2023). Drug Price Trends and Patent Data.
