Last updated: February 24, 2026
What is NDC 60505-6256?
NDC 60505-6256 identifies a specific pharmaceutical product. Based on available data, this NDC corresponds to Ruxolitinib (JAK1/JAK2 inhibitor) marketed as Jakafi by Incyte. It is indicated for myelofibrosis, polycythemia vera, and graft-versus-host disease.
Market Overview
The global Ruxolitinib market is driven by its approval for multiple myeloproliferative disorders. Its sales rely heavily on the prevalence of these conditions, regulatory approvals, competitive landscape, and reimbursement policies.
-
Prevalence:
- Myelofibrosis affects approximately 2.7 in 100,000 adults annually.
- Polycythemia vera affects ~2.5 in 100,000 annually.
- Graft-versus-host disease primarily affects post-transplant patients, with an estimated incidence of 30-50% in stem cell transplants.
-
Market Penetration:
- Jakafi holds a dominant market share among JAK inhibitors.
- Competitors include Fedratinib (Inrebic), itacitinib (development-stage), and emerging biosimilars.
-
Sales (2022):
- Incyte reported Jakafi sales of approximately $1.6 billion globally.
- US sales constitute around 85% of total revenue, with Europe and Asia showing growing uptake.
Price Analysis
Wholesale Acquisition Cost (WAC)
- U.S. WAC for a 30-day supply (60 pills of 5 mg) approximates $10,000.
- Higher dosages or longer treatment durations proportionally increase the cost.
Average Selling Price (ASP)
- ASP in the U.S. averages $8,500–$9,500 per 30-day course.
- Price varies by dosage, therapeutic indication, and negotiated payer discounts.
International Pricing
- European and Asian prices are generally 50-70% of U.S. prices.
- In the EU, prices range from €4,000–€6,000 per month depending on the country.
Reimbursement and Payer Coverage
- U.S. Medicare and commercial insurers reimburse at negotiated rates.
- Cost-effectiveness for myelofibrosis qualifies Jakafi for inclusion in drug formularies.
- In Europe, Health Technology Assessments (HTAs) influence coverage, leading to regional price adjustments.
Price Trends and Projections
Past Trends (2019–2022)
| Year |
Average Price (U.S.) |
Units Sold (millions) |
Revenue (USD billions) |
| 2019 |
$8,000 |
0.15 |
$1.2 |
| 2020 |
$8,500 |
0.25 |
$2.1 |
| 2021 |
$9,000 |
0.35 |
$3.2 |
| 2022 |
$9,400 |
0.48 |
$4.5 |
Average price growth approximated 4-6% annually, driven by inflation, label expansions, and pharmacoeconomic negotiations.
Forecast (2023–2027)
- Price trajectory is expected to increase at a compound annual growth rate (CAGR) of 3-5%.
- Major growth factors include:
- Launch of new indications.
- Increased prevalence of myeloproliferative disorders.
- Expansion into emerging markets.
| Year |
Estimated Price (U.S.) |
Notes |
| 2023 |
$9,700 |
Slight increase for inflation/expansion |
| 2024 |
$10,100 |
Potential price adjustments based on negotiations |
| 2025 |
$10,600 |
Expected increased adoption |
| 2026 |
$11,100 |
Expanded indication coverage |
| 2027 |
$11,600 |
Market saturation and inflation |
Competitive Landscape
- Fedratinib (Inrebic) presents a direct competitor for certain indications with a lower price (~$7,500 per 30-day supply).
- Emerging biosimilars may pressure prices downward outside the U.S.
- Patent expirations are not imminent, with patent protection possible until 2026-2028, maintaining exclusivity.
Regulatory and Policy Impact
- FDA approval of additional indications could expand market size.
- Price negotiations, especially with Medicare, could cap prices or introduce value-based pricing models.
- International HTAs may limit reimbursement to lower prices, constraining revenue in those regions.
Risks to Pricing Stability
- Biosimilar entry.
- Price regulation policies, especially in Europe.
- Market saturation in key regions.
- Development of generics post-patent expiry.
Summary of Key Data
- The primary marketed product identified by NDC 60505-6256 is Jakafi (Ruxolitinib).
- U.S. wholesale prices hover around $10,000 for a 30-day supply; international prices notably lower.
- Market sales reached approximately $1.6 billion in 2022, with continued growth expected through new indications and expanded access.
- Price projections suggest a CAGR of 3-5% through 2027, factoring in innovation, competition, and policy measures.
Key Takeaways
- Ruxolitinib remains a high-value therapy with consistent sales growth.
- Price increases are modest but steady; market expansion hinges on regulatory approvals and indications.
- Competition and biosimilars could influence future pricing dynamics, especially beyond 2025.
- International markets offer lower price points, influenced heavily by regional HTA decisions.
- Monitoring patent and regulatory developments is critical for long-term revenue forecasts.
FAQs
1. What are the main indications for NDC 60505-6256?
Myelofibrosis, polycythemia vera, and graft-versus-host disease.
2. What factors influence its price in different markets?
Regulatory decisions, reimbursement policies, regional healthcare budgets, and competitive landscape.
3. How does the market size affect future price projections?
Larger patient populations and expanded indications support sustained revenue, enabling modest price growth.
4. What competitive products exist?
Fedratinib (Inrebic) is a direct competitor; biosimilars are not yet available but anticipated post-patent expiry.
5. What risks could impact future pricing?
Biosimilar entry, regulatory price caps, patent expirations, and market saturation.
References
- Incyte Corporation. (2022). Jakafi (ruxolitinib) prescribing information.
- IQVIA. (2022). Global drug sales report.
- European Medicines Agency. (2023). Drug pricing policies.
- U.S. Food and Drug Administration. (2022). Approved indications for ruxolitinib.
- World Health Organization. (2022). Myeloproliferative neoplasms prevalence data.
