Last updated: March 2, 2026
What is NDC 65862-0941?
NDC 65862-0941 refers to a specific pharmaceutical product listed in the National Drug Code (NDC) database. It is essential to identify the drug, its therapeutic class, formulation, and approved indications to conduct an accurate market analysis.
Based on public databases and product catalogs, NDC 65862-0941 corresponds to Ruxolitinib (brand name Jakafi), a Janus Kinase (JAK) inhibitor used primarily for myelofibrosis, polycythemia vera, and corticosteroid-refractory acute graft-versus-host disease (GVHD).
Note: Confirm the exact product with the official FDA database, as NDC numbers can be updated or reassigned.
Market Size and Dynamics
Indications and Market Demand
Ruxolitinib (Jakafi) was approved by the FDA in 2011 for myelofibrosis (MF) and polycythemia vera (PV), with additional approvals for acute GVHD in 2021.
- Estimated US market value: approximately $1.3 billion in 2022 (IQVIA).
- Key indications include rare blood cancers, with limited patient populations:
- Myelofibrosis: 3,200 patients (US estimates)
- Polycythemia vera: 3,200 patients (US estimates)
- Acute GVHD: It is an area of expansion with growing prescribing.
Competition Landscape
The primary competitor is Fedratinib (Inrebic), another JAK inhibitor approved for myelofibrosis.
- No direct competitors for GVHD at current market levels.
- Biosimilar or generic entry remains unlikely due to patent protections extending until at least 2030.
Pricing Trends
- Current Average Wholesale Price (AWP): approximately $87,000 to $95,000 annually per patient.
- Managed care discounts and rebates may lower the net price by 20-30%.
- Price increases over the last decade have averaged 2-3% annually, consistent with inflation and rising R&D costs.
Price Projections (2023-2027)
Based on clinical expansion, patent protections, and market conditions, Ruxolitinib prices are projected to remain stable with modest growth.
| Year |
Estimated Average Price (per patient/year) |
Comments |
| 2023 |
$87,500 |
Current level |
| 2024 |
$89,000 |
Slight inflationary increase |
| 2025 |
$90,500 |
Expected market stabilization |
| 2026 |
$92,000 |
Slight upward trend |
| 2027 |
$93,500 |
No major pricing pressures anticipated |
Influencing Factors
- Expansion into GVHD indications increases overall sales volume.
- Potential biosimilar development could pressure prices post-2030 but unlikely within forecast horizon.
- Payer negotiations and value-based pricing initiatives could impact net revenues more than gross prices.
Regulatory and Policy Impact
- FDA approval for additional indications may boost market size.
- Price regulation pressures, both domestically and in managed care, could counteract upward pricing trends.
- Patent protection lapses are projected beyond 2030, with biosimilar entry possible thereafter.
Key Market Considerations
- Growth driven by expanded indications and increasing prevalence.
- Reimbursement strategies critical for maximizing revenue.
- Competition from newer JAK inhibitors and pipeline drugs may limit pricing power.
Summary
NDC 65862-0941, representing Ruxolitinib, maintains a stable pricing pattern with potential incremental growth driven by expanded indications. The US market remains concentrated with limited long-term competition, supporting sustained revenue projections until patent expiration.
Key Takeaways
- NDC 65862-0941 (Ruxolitinib) generated approximately $1.3 billion in US sales in 2022.
- Commitments to expand indications, particularly GVHD, are a primary growth driver.
- Current annual treatment costs hover around $87,000 to $95,000, with modest increases forecasted over the next five years.
- Patent protection extends beyond 2030, with biosimilar competition unlikely before then.
- Market dynamics are influenced by regulatory approval, payer negotiations, and potential biosimilar developments.
FAQs
1. What are the main indications for NDC 65862-0941?
Ruxolitinib is indicated for myelofibrosis, polycythemia vera, and has received approval for certain cases of acute graft-versus-host disease.
2. How does the competitive landscape look for this drug?
The primary competitor is Fedratinib. Biosimilars are not available yet, maintaining Ruxolitinib’s market dominance until patent expiry.
3. What factors could impact the drug’s price in the future?
Regulatory changes, patent expiration, biosimilar entry, and payer negotiations are primary factors influencing future pricing.
4. Is the treatment cost expected to decrease with biosimilar products?
Potentially, but biosimilar availability is likely beyond 2030, so immediate impact in the forecast period is minimal.
5. How do reimbursement policies influence pricing?
Reimbursement strategies may limit net revenues or promote value-based arrangements, indirectly affecting gross prices.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] FDA. (2022). Drug Approvals and Indications.
[3] Medscape. (2023). Ruxolitinib (Jakafi) Pricing Analysis.
[4] FDA. (2022). Patent & Exclusivity Data.
[5] GlobalData. (2022). Oncology Market Forecasts.
