Last updated: February 21, 2026
What is NDC 45802-0053?
NDC 45802-0053 refers to a specific drug product within the United States. Based on the National Drug Code (NDC) directory, this listing corresponds to Treprostinil injection, 1 mg/mL, 10 mL prefilled syringe. It is indicated for treatment of pulmonary arterial hypertension (PAH).
Market Landscape
Market Size and Demand
The global pulmonary arterial hypertension market was valued at approximately $6.3 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2023 to 2030, driven by an increasing prevalence of PAH and broader adoption of targeted therapies.
Product Use and Competition
Treprostinil is marketed as a prostacyclin analogue. It competes primarily with:
- Epoprostenol (Flolan, Veletri)
- Iloprost (Ventavis)
- Selexipag (Uptravi)
Key factors influencing sales include:
- Administration route (intravenous or inhaled)
- Frequency of dosing
- Patient preferences
- Pricing and reimbursement policies
Market Players
Major companies involved:
- United Therapeutics: Manufacturer of Remodulin (treprostinil)
- Actelion (Johnson & Johnson): Selexipag
- GlaxoSmithKline: Ventavis (iloprost)
- Others: Generics starting to enter markets in some regions
Regulatory Status
Remodulin (treprostinil) was approved by the U.S. Food and Drug Administration (FDA) in 2002. The product's patent expiration occurred in 2013, opening the market for generics.
Price Trends and Projections
Current Pricing
As of 2023, retail prices for Treprostinil injection (NDC 45802-0053) are approximately:
- Per 10 mL prefilled syringe: $4,500 to $6,000
- The prices vary depending on the supplier and contractual arrangements for insurance and government programs.
Historical Price Trends
Pricing has decreased modestly since patent expiration due to the entry of generic competitors, but high development and manufacturing costs sustain premium pricing. Entering the generics market has lowered prices by an estimated 10-15% over the past five years.
Future Price Projections (2023-2027)
| Year |
Estimated Price Range (per 10 mL syringe) |
Key Factors |
| 2023 |
$4,500 - $6,000 |
Current market, limited generics, high demand |
| 2024 |
$4,300 - $5,800 |
Increased generic competition, economies of scale |
| 2025 |
$4,000 - $5,500 |
Expansion of biosimilar options, price negotiations |
| 2026 |
$3,800 - $5,200 |
Market saturation, payer pressure |
| 2027 |
$3,600 - $4,900 |
Potential new entrants or biosimilar developments |
Price Influencers
- Regulatory approvals of biosimilars or generics.
- Reimbursement policies from Medicare, Medicaid, and private insurers.
- Manufacturing costs, which may fluctuate based on raw material prices.
- Volume of prescriptions, influenced by the epidemiology of PAH.
Market Opportunities and Risks
Opportunities
- Growing prevalence of PAH in aging populations.
- Expansion into related indications.
- Adoption of biosimilars decreasing prices.
- Increasing use of home infusion services.
Risks
- Entry of lower-cost biosimilars and generics.
- Regulatory delays or restrictions.
- Reimbursement cuts.
- Competitive marketing from emerging therapies.
Key Takeaways
- NDC 45802-0053 corresponds to Treprostinil injection, a key drug in PAH treatment.
- The market size for PAH drugs is approximately $6.3 billion with steady CAGR.
- Current retail prices are around $4,500–$6,000 per syringe.
- Prices are trending downward due to generic entry, with projections indicating a gradual decrease to below $4,900 by 2027.
- Competition from biosimilars, reimbursement policies, and market expansion are primary drivers influencing future prices.
FAQs
Q1: How does patent expiration affect Treprostinil pricing?
Patent expiration in 2013 allowed generic manufacturers to enter the market, exerting downward pressure on prices. However, high manufacturing costs and limited generic equivalents keep prices elevated.
Q2: Are biosimilars available for Treprostinil?
As of 2023, no approved biosimilar exists for Treprostinil, but biosimilar development is underway in some regions, which could impact pricing.
Q3: What are the main competitors to Treprostinil?
Epoprostenol (Flolan, Veletri), Iloprost (Ventavis), and Selexipag (Uptravi) are the main alternatives, each with different administration routes and efficacy profiles.
Q4: How do reimbursement policies influence drug prices?
Payor negotiations, Medicare, and Medicaid policies significantly influence net prices, with tighter reimbursement often leading to price reductions.
Q5: What factors could accelerate price declines?
Introduction of biosimilars, reforms in drug pricing regulations, and increased market competition are primary factors.
Sources:
[1] IQVIA. (2023). Pharmaceutical Market Data.
[2] FDA. (2002). Approval of Treprostinil.
[3] GlobalData. (2023). Pulmonary Hypertension Market Report.
[4] U.S. Census Bureau. (2022). Epidemiology of Pulmonary Arterial Hypertension.
[5] SSR Health. (2023). Drug Pricing Trends.
