Last updated: February 15, 2026
Overview of NDC 60505-0582
NDC 60505-0582 refers to Selexipag, marketed under the brand name Uptravi by Actelion Pharmaceuticals. Approved by the FDA in December 2015, Selexipag is used for treating pulmonary arterial hypertension (PAH).
Market Context
The PAH therapeutic market has experienced steady growth owing to increased diagnosis and expanding treatment indications. Selexipag competes primarily with ERAs (endothelin receptor antagonists), PDE5 inhibitors, and prostacyclins.
Market Size and Trends
Global Market
Expected to reach approximately $5 billion by 2027, driven by:
- Growing prevalence of PAH (estimated 15–50 cases per million globally)
- Increased treatment adoption due to better awareness and diagnosis
- Expanding indications for PAH, including connective tissue disease-associated PAH
U.S. Market
Estimated worth approximately $1.2 billion in 2022, with a compound annual growth rate (CAGR) of 7% between 2022–2027.
Key Market Drivers
- Advances in PAH diagnosis and management
- Launch of combination therapies including Selexipag
- Payer reimbursement policies favoring newer oral agents over intravenous options
Competitive Landscape
Major competitors include:
- Epoprostenol (Flolan)
- Bosentan (Tracleer)
- Ambrisentan (Letairis)
- Macitentan (Opsumit)
- Riociguat (Adempas)
Selexipag's oral route offers convenience over intravenous therapies, contributing to its market share.
Pricing Structures
Current Pricing
In the U.S., typical wholesale acquisition cost (WAC) for Selexipag ranges from $22,000 to $25,000 per year per patient, depending on dosing.
| Dose (mg) |
Approximate Monthly Cost |
Notes |
| 200 mg |
$2,000 |
Common maintenance dose |
| 160 mg - 320 mg |
$1,600–$2,400 |
Variable based on titration |
Prices vary with dose and insurance negotiations but generally hold steady across payers.
Price Projection Factors
- Market penetration increases with new combination approvals
- Patent exclusivity until 2030-2032
- Emergence of biosimilars or generics is unlikely before patent expiry
- Pricing pressure from healthcare systems due to high drug costs
Short-term Projection (2023–2025)
Prices will likely stabilize with minimal fluctuations due to:
- Established market position
- Limited patent challenge activity
- Payer resistance to high-cost drugs
Expected retail WAC: $23,000–$26,000 annually per patient.
Mid- to Long-term Projection (2025–2030)
Possible slight decline (~3–5%) as:
- Volume increases
- Negotiated rebates and discounts deepen
- Payers push for cost-effective alternatives
If biosimilars enter the market post-2030, prices could decline by up to 30%.
Regulatory and Policy Impact
Upcoming policies aimed at controlling drug costs, including value-based pricing and expanded generic pathways, could influence Selexipag pricing post-2030. The drug’s patent landscape remains stable until at least 2030, supporting current pricing.
Risks and Opportunities
Risks:
- Entry of biosimilars or generics after patent expiry
- Changes in payer reimbursement policies
- Market saturation as new PAH therapies emerge
Opportunities:
- Expansion into additional PAH indications
- Development of combination formulations
- Increased uptake in underserved markets
Key Takeaways
- Selexipag (NDC 60505-0582) operates in a growing, competitive PAH market.
- Current U.S. pricing is approximately $23,000–$26,000 annually per patient.
- Market growth will influence revenue but limited near-term price declines.
- Long-term prices are contingent on patent expiry and biosimilar entry.
- Payer policies and innovation shifts present potential price risks and opportunities.
FAQs
1. When does patent protection for Selexipag expire?
Patent protections are expected to last until around 2030–2032, delaying biosimilar competition.
2. How does Selexipag’s price compare to other PAH therapies?
It is priced higher than older oral agents like bosentan (~$5,000/year) but less costly than intravenous prostacyclins (~$100,000/year).
3. What is the anticipated impact of biosimilars on Selexipag’s price?
Entry of biosimilars could reduce prices by up to 30%, contingent on regulatory approval and market uptake.
4. Are price reductions likely in the next two years?
Most likely limited; stabilization around current levels is expected due to existing patents and market dynamics.
5. How does insurance coverage affect the actual cost to patients?
Rebates, copay assistance, and negotiations mean actual patient costs are often lower than wholesale prices.
References
[1] GlobalData, "Pulmonary Arterial Hypertension Market Report," 2022.
[2] IQVIA, "Pharmaceutical Market Trends," 2022.
[3] U.S. FDA, "Drug Approvals and Patent Expirations," 2023.
[4] Actelion Pharmaceuticals, "Uptravi Pricing and Coverage," 2023.
