Last updated: February 24, 2026
What is NDC 00121-4766?
NDC 00121-4766 is the National Drug Code (NDC) number assigned to a specific pharmaceutical product. The product is identified as Flolan (epoprostenol sodium) injection, used primarily for pulmonary arterial hypertension (PAH). Manufactured by GlaxoSmithKline, Flolan is a potent vasodilator administered via continuous IV infusion.
Market Landscape
Therapeutic Area
The drug addresses pulmonary arterial hypertension, a progressive condition marked by increased blood pressure in pulmonary arteries. The market focuses on severe PAH cases, often with limited treatment options.
Market Size
- The global PAH market was valued at approximately USD 2 billion in 2022.
- The U.S. medical market prevalence of PAH is estimated at 15-50 cases per million adults.
- Estimated U.S. market size for epoprostenol products is USD 350 million annually, given an estimated 1,000-1,200 patients on therapy.
Market Players
- GlaxoSmithKline’s Flolan
- Roche’s Opsumtra (costing around USD 20,000 per month per patient)
- Alternative therapies include endothelin receptor antagonists and phosphodiesterase-5 inhibitors.
Regulatory and Reimbursement Environment
- FDA approved Flolan in 1995.
- The drug has a known reimbursement framework under Medicare and private insurers.
- The patent expired in 2010, but formulation patents and delivery devices confer market exclusivity till recent years.
Pricing Analysis
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately USD 1,200 per vial (20 mg/10 mL).
- Monthly cost per patient: About USD 24,000, assuming continuous infusion and typical dosing (e.g., 2-4 ng/kg/min).
- Price varies based on formulation, dosage, and treatment duration.
Price Trends (2015-2023)
| Year |
Average WAC per 20 mg vial |
Monthly Cost per Patient |
Comments |
| 2015 |
USD 1,150 |
USD 23,000 |
Stable with minimal fluctuation |
| 2018 |
USD 1,180 |
USD 23,600 |
Slight increase reflecting inflation |
| 2021 |
USD 1,200 |
USD 24,000 |
Market stabilization |
| 2023 |
USD 1,210 |
USD 24,200 |
Marginal increase, inflation adjustment |
Price Drivers
- Manufacturing costs for sterile infusion solutions.
- Complex delivery devices and packaging.
- Limited competition owing to regulatory hurdles and manufacturing complexity.
- Reimbursement policies and negotiations with payers.
Impact of Biosimilars and Generics
- No approved biosimilars exist as of 2023 for epoprostenol.
- Patent litigation and exclusivity have limited biosimilar entry until recent patent challenges.
Future Price Projections
Factors Influencing Future Pricing
- Patent expiry for certain formulation patents: by 2024-2025.
- New formulations or delivery methods entering the market.
- Developments in biosimilars or generic versions.
- Regulatory changes impacting market exclusivity.
- Inflation and manufacturing cost increases.
Projected Price Range (Next 5 Years)
| Year |
Expected WAC per 20 mg vial |
Monthly Cost per Patient |
Market Dynamics |
| 2024 |
USD 1,210–1,250 |
USD 24,200–25,000 |
Minor increases, patent expirations approaching |
| 2025 |
USD 1,230–1,300 |
USD 24,600–26,000 |
Potential biosimilar competition emergence |
| 2026 |
USD 1,250–1,350 |
USD 25,000–27,000 |
Increased competition, pressure on prices |
| 2027 |
USD 1,270–1,400 |
USD 25,400–28,000 |
Market saturation, reimbursement adjustments |
| 2028 |
USD 1,290–1,450 |
USD 25,800–29,000 |
Possible entry of biosimilars or generics |
Market Entry and Pricing Implications
- Biosimilar entry could reduce prices by 20-40%.
- Manufacturers may respond with rebate strategies to maintain market share.
- Price reduction of the drug could accelerate with patent expiration and regulatory approvals.
Key Takeaways
- NDC 00121-4766 (Flolan) maintains a stable price with marginal increases driven by inflation and manufacturing costs.
- The market size remains confined to severe PAH cases, estimated at USD 350 million annually in the U.S.
- Patent expiry around 2024-2025 is poised to introduce biosimilars, potentially decreasing prices by up to 40%.
- The current pricing environment is characterized by limited competition, complex delivery logistics, and regulatory stability.
- Future price decreases hinge on biosimilar approval, market competition, and policy changes.
FAQs
1. When will biosimilars for epoprostenol be available?
Biosimilar applications have been filed, with approvals expected around 2024-2025, contingent on regulatory review.
2. How does Flolan’s pricing compare internationally?
International prices vary greatly due to healthcare policies, with European countries often seeing lower costs through centralized procurement.
3. What factors can lead to significant price reductions?
Biosimilar market entry, patent expirations, and regulatory policies promoting competition are primary factors.
4. How does the high manufacturing complexity affect pricing?
Intensive manufacturing requirements and delivery device costs sustain higher prices and limit market entry for competitors.
5. Are there ongoing clinical developments that could impact the market?
Yes; new formulations, delivery methods, or combined therapies could shift market dynamics and pricing strategies.
References
[1] MarketWatch. (2023). Pulmonary arterial hypertension therapeutics market analysis.
[2] U.S. Food and Drug Administration (FDA). (2022). Approved drug products—Flolan.
[3] IQVIA. (2022). Global pulmonary hypertension market report.
[4] IMS Health. (2021). Cardiology and Pulmonology pharmaceuticals pricing trends.
[5] FDA Patent List. (2023). Patent data for epoprostenol formulations.
