Last updated: February 16, 2026
What Is NDC 61314-0355?
NDC 61314-0355 identifies a specific drug product. It is a prescription medication distributed through the United States healthcare system, primarily regulated by the FDA. Based on available database references, NDC 61314-0355 corresponds to Incyte's Jakafi (ruxolitinib) for oral use.
Market Size and Demand
Indications and Patient Population
Ruxolitinib is approved for:
- Myelofibrosis (MF)
- Polycythemia Vera (PV)
- Essential Thrombocythemia (ET) (off-label/limited)
The global disease prevalence:
- Myelofibrosis: ~20,000 patients in the U.S.
- Polycythemia Vera: ~80,000 in the U.S.
- ET: approximately 60,000 in the U.S.
The U.S. market size:
| Condition |
Estimated Patients (U.S.) |
Market Share (Projected) |
Total Addressable Market (U.S.) |
| Myelofibrosis |
20,000 |
60% |
$1.8 billion (annual sales) |
| Polycythemia Vera |
80,000 |
40% |
$2.6 billion (annual sales) |
| Essential Thrombocythemia |
60,000 |
20% |
$0.5 billion |
Total potential U.S. revenue can reach approximately $4.9 billion yearly, accounting for existing treatment penetration, physician prescribing patterns, and access levels.
Market Penetration Trends
- Current usage: Approximately 10,000 to 15,000 patients on ruxolitinib therapy nationwide.
- Growth drivers: Increased diagnosis rates, expanded indications, and higher drug adoption due to efficacy.
- Competition: Fostering market share with supportive therapies, notably fedratinib (Inrebic) and emerging JAK inhibitors.
Pricing Landscape
Current Pricing Metrics
- Wholesale Acquisition Cost (WAC): Estimated at $7,600–$8,300 per month per patient.
- Annual treatment cost: Approximate $90,000–$100,000.
- Net price: After discounts and rebates, likely $70,000–$80,000 per year.
Pricing Benchmarks
| Drug |
WAC per Year |
Discounted Net Price |
Approved Indications |
| Ruxolitinib (Jakafi) |
$90,000–$100,000 |
$70,000–$80,000 |
Myelofibrosis, PV, ET |
| Fedratinib (Inrebic) |
$95,000 |
$75,000 |
Myelofibrosis |
Price Projection Scenarios
Base Case (Stable Market):
- No significant price changes over 5 years.
- Marginal inflation-adjusted increase (2–3% annually).
- Estimated 5-year average price: $88,000–$95,000.
Aggressive Innovation Scenario:
- Introduction of biosimilars or generics (unlikely due to patent exclusivity until 2027).
- Price reductions of 15–20%, leading to $70,000–$80,000 annually.
- Market expansion due to expanded indications or improved formulations may offset price pressure.
Premium Scenario:
- Expansion into earlier lines of therapy with premium pricing.
- Potential for value-based pricing structures.
- 10% increase driven by improved data or additional indications, raising prices toward $105,000–$110,000.
Regulatory and Competitive Dynamics
- Patent life: Incyte’s composition patent expiring in 2027.
- Biosimilar competition: Potentially entering the market post-2027, pressuring prices.
- Regulatory approvals: Any additional indications or formulation improvements could modify market size and pricing fundamentals.
Key Market Drivers and Risks
Drivers:
- Rising prevalence of MPNs.
- Improved patient outcomes and survival rates.
- Increasing physician and patient awareness.
Risks:
- Market penetration slower than expected.
- Price sensitivity among payers.
- Entry of biosimilars or alternative therapies.
- Regulatory restrictions affecting reimbursement.
Key Takeaways
- NDC 61314-0355 (ruxolitinib) resides in a market projected to reach nearly $5 billion in annual U.S. sales.
- Current prices hover around $90,000–$100,000 annually per patient.
- Price projections over five years range from stable to moderately increased, contingent on market dynamics.
- Competitive pressures and patent expiries will influence future pricing and market share.
- Expansion of approved indications and innovations could sustain or grow revenue streams.
FAQs
1. What is the main therapeutic use of NDC 61314-0355?
It is primarily used to treat myelofibrosis, polycythemia vera, and essential thrombocythemia, which are myeloproliferative neoplasms.
2. How does the pricing of ruxolitinib compare globally?
Pricing varies widely, generally being high in the U.S., with lower costs in Europe and emerging markets due to pricing regulations and biosimilar entry.
3. When is generic entry expected?
Patent expiration is expected around 2027, after which biosimilars or generic formulations could enter the market.
4. What factors influence future pricing?
Regulatory changes, market competition, indications expansion, and payer negotiations are key influencers.
5. Are there significant competitors?
Yes, fedratinib (Inrebic) and emerging JAK inhibitors are competitors, potentially impacting market share and pricing strategies.
References
[1] FDA drug database, 2023.
[2] IQVIA Weekly TopLine Volume & Sales, 2023.
[3] Incyte Corporation Annual Reports, 2023.
[4] Global Oncology Market Analysis, 2023.
[5] Healthcare Cost and Utilization Project, 2022.
