Last updated: March 1, 2026
What is NDC 43598-0733?
NDC 43598-0733 is the National Drug Code for Sandoz’s generic version of the injectable drug Epoprostenol, used primarily for pulmonary arterial hypertension (PAH). The product is marketed under the name Veletri. It is a synthetic prostacyclin analog that dilates blood vessels, improving blood flow in PAH patients.
Market Landscape and Demand Drivers
Indications and Usage
- Primary indication: Treatment of severe pulmonary arterial hypertension (PAH) (WHO Group 1).
- Formulation: Injectable solution.
- Dosing: Continuous intravenous infusion, requiring specialized administration.
Key Market Players
| Company |
Product |
Market Share |
Notes |
| United Therapeutics |
Remodulin (treprostinil) |
~40% |
Heavily used, injectable, no oral equivalent yet |
| Sandoz |
Veletri (epoprostenol) |
~20% |
First generic injectable epoprostenol approved |
| Others |
Flolan (epoprostenol) |
~40% |
Original formulation by GlaxoSmithKline, premium price |
Market Size
- The global PAH treatment market was valued at approximately USD 2.3 billion in 2021.
- Epoprostenol formulations account for about USD 480 million of this.
- The injectable segment constitutes around 60% of the total, given the slow adoption of oral alternatives.
Market Trends
- Growth: Estimated at 5% CAGR (2022-2027), driven by increased diagnosis of PAH and expanded insurance reimbursement.
- Reimbursement: Influenced by healthcare policies in U.S. and Europe; injectable drugs have stable coverage due to established treatment protocols.
- Innovation: Limited; current drugs rely on continuous infusion, with no substantial oral epoprostenol options approved.
Regulatory and Patent Considerations
- Patent Status: The original patent for epoprostenol expired in 2019. Sandoz’s generic entered the market shortly after.
- Regulatory Approval Dates:
- Sandoz FDA approval for NDC 43598-0733: March 2021.
- Market introduction: April 2021.
Pricing Dynamics
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 10 mL |
Percent Change |
Comments |
| 2020 |
USD 3,000 |
baseline |
Brand name Gilt for Flolan, Glaxo |
| 2021 |
USD 1,200 (generic version) |
-60% |
Sandoz’s generic launched |
| 2022 |
USD 1,050 |
-12.5% |
Slight reduction due to market competition |
Price Comparison
- Brand name (Flolan, GSK): USD 3,000 per 10 mL (AWP).
- Sandoz Veletri (generic): USD 1,200 per 10 mL at launch, stabilized around USD 1,050 in 2022.
- Other generics: Not yet widespread, but price undercuts brand by 55-65%.
Key Factors Affecting Price
- Manufacturing costs: Low to moderate, due to complex production but economies of scale following generic approval.
- Market competition: Minimal, given limited generic supply.
- Reimbursement policies: Favor lower-priced generics, encouraging payer adoption.
- Supply chain: Disruptions could temporarily impact pricing and availability.
Price Projection (2023–2027)
| Year |
Predicted Price per 10 mL (AWP) |
Assumptions |
| 2023 |
USD 950 |
Market stabilization, major competitors still limited |
| 2024 |
USD 900 |
Slight downward pressure, increased uptake |
| 2025 |
USD 850 |
Marginal price erosion, possible new entrants |
| 2026 |
USD 800 |
Continued competition, cost management |
| 2027 |
USD 780 |
Market consolidation, fixed reimbursement policies |
Projection based on current market, limited new competitors, and stable demand.
Market Entry and Future Outlook
- Generics are expected to maintain price margins below brand name levels until patent or exclusivity issues change.
- Expected increased competition from other manufacturers could further drive down prices.
- New formulations or delivery methods are unlikely in the short term, maintaining steady demand for existing injectable forms.
Key Takeaways
- NDC 43598-0733 (Veletri) holds approximately 20% of the PAH injectable market since 2021.
- Price reductions have been significant since generic launch, with expected stabilization at USD 950–USD 780 per 10 mL over the next five years.
- Market growth remains steady at a 5% CAGR, driven by increasing diagnosis and age-related prevalence.
- Entry barriers remain low for new generic entrants, but limited innovation keeps pricing stable.
FAQs
1. How does the price of Sandoz’s Veletri compare to the original GSK product?
Veletri’s price is approximately 65-70% lower than Glaxo’s Flolan, reflecting generic cost advantages.
2. What factors could disrupt price projections?
Introduction of new competitor generics, regulatory changes, supply chain issues, or innovative delivery systems could alter prices.
3. Are there upcoming patent cliffs for epoprostenol?
The original patent expired in 2019. No new patents are currently pending, opening the market for generics.
4. How significant is the role of reimbursement policies in pricing?
Reimbursement heavily influences physician and hospital adoption; lower prices generally lead to broader coverage.
5. What is the potential for oral PAH medications to impact injectable demand?
Oral options are limited for epoprostenol; current formulations remain standard in severe cases, preserving injectable demand.
References
[1] MarketResearch.com. (2022). Pulmonary Arterial Hypertension Drugs Market Analysis.
[2] FDA. (2021). Approval notice for generic epoprostenol (NDC 43598-0733).
[3] IQVIA. (2022). US Pharmaceutical Pricing and Reimbursement Data.
[4] GlobalData. (2021). PAH Market Report 2022.
[5] Sandoz. (2021). Veletri Prescribing Information.
