Last updated: February 23, 2026
What is the Drug Corresponding to NDC 31722-0391?
The National Drug Code (NDC) 31722-0391 refers to Ruxolitinib (brand name Jakafi), a Janus kinase (JAK) inhibitor approved for myelofibrosis, polycythemia vera, and graft-versus-host disease (GVHD). It is marketed by Incyte Corporation.
Market Size and Growth Dynamics
Current Market Landscape
- The global myeloproliferative neoplasm (MPN) treatment market was valued at approximately USD 1.8 billion in 2022.
- Ruxolitinib accounts for a significant share, estimated at USD 1.2 billion in 2022, due to its approved indications and market penetration.
- The drug's prescription volume grew steadily at 8% CAGR from 2018 to 2022.
Target Patient Population
| Condition |
Estimated Prevalence (US) |
Eligible Patients (US) |
Key Factors |
| Myelofibrosis |
5,000–7,000 patients/year |
85% receive JAK inhibitor |
Rare disease, high unmet need |
| Polycythemia Vera |
9,000–10,000 patients |
Approximately 60% treated |
Chronic, slow progression |
| Chronic GVHD |
4,000–6,000 cases/year |
50–70% treated with Ruxolitinib |
Growing indication since 2019 |
Competitive Position
- Ruxolitinib faces competition from fedratinib (Incyte, approved for myelofibrosis) and emerging biosimilars.
- No biosimilar versions approved yet, allowing Incyte to maintain pricing power.
Pricing and Reimbursement
- Average wholesale price (AWP) per month: USD 11,500 – USD 13,000.
- Reimbursement typically covers 80–95% via private insurers and Medicare.
- Price sensitivity is limited due to limited alternative treatments and rarity of indications.
Price Projections
Short-term Forecast (2023–2025)
-
Price Stability: Due to lack of biosimilar competition and high demand, prices are expected to stay within the current range.
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Market Growth: Prescriber expansion in GVHD could generate a 5–8% annual volume increase, offset by 2–3% annual price erosion due to payer negotiations.
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Revenue Outlook: Incyte's revenues from Ruxolitinib are projected to grow from USD 1.2 billion in 2022 to approximately USD 1.4 billion in 2025.
Long-term Outlook (2026–2030)
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Market Expansion Factors:
- Broader adoption in new indications such as COVID-19 related cytokine storm or autoimmune diseases.
- Increased off-label use driven by emerging clinical trials.
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Pricing Dynamics:
- Introduction of biosimilars may reduce prices by 20–30% over the decade.
- However, clinical efficacy and patent protections are likely to sustain premium pricing for the foreseeable future.
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Projected Revenue Range: USD 1.4 to USD 1.6 billion by 2030, assuming moderate biosimilar penetration and stable demand.
Regulatory Considerations and Impact on Pricing
- Patent Protects: Patents expired in late 2021; however, pediatric exclusivity and formulation patents extend exclusivity until at least 2027.
- Approval of biosimilars or new formulations (e.g., subcutaneous vs. oral) could influence pricing.
Key Drivers and Risks
| Drivers |
Risks |
| Growing prevalence of indications |
Entry of generic/biosimilar competitors |
| Increasing use in GVHD indications |
Regulatory hurdles or safety concerns |
| Reimbursement and coverage stability |
Price negotiations limiting reimbursement margins |
Summary
Ruxolitinib maintains dominant market share in its indications. Price stability is expected over the next two years, with potential for moderate decline if biosimilars are approved. Revenue projections for 2023–2025 estimate a growth trajectory to USD 1.4 billion, with long-term prospects hinging on new indications and regulatory exclusivities.
Key Takeaways
- NDC 31722-0391 corresponds to Ruxolitinib (Jakafi).
- The drug retains high demand due to its strong position and lack of biosimilar competition.
- Prices are expected to remain stable through 2025, with slight declines possible after patent expirations.
- Revenue for Incyte is projected to increase slightly, driven by volume growth and expanding indications.
- Long-term pricing could face downward pressure from biosimilar entry, but patent protections and clinical reliance support sustained revenues.
FAQs
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How does biosimilar entry affect Ruxolitinib prices?
Biosimilars could reduce prices by 20–30%, impacting revenue and market share over time.
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What are the main competitors to Ruxolitinib?
Fedratinib (Incyte) and emerging biosimilars. Other JAK inhibitors like baricitinib and tofacitinib are more used in autoimmune diseases.
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Are there synthetic alternatives for the indications?
Currently, no. No available oral JAK inhibitors approved for myelofibrosis have similar efficacy, reinforcing Ruxolitinib’s position.
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How does regulatory status influence future pricing?
Patent exclusivities and approved indications delay biosimilar entry, supporting stable prices until at least 2027.
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What factors could accelerate market growth?
Expanded approval for additional indications and increased off-label use could boost demand by 10–15% annually.
References
[1] Incyte Corporation. (2023). Jakafi (ruxolitinib) prescribing information.
[2] Global Data. (2022). Myeloproliferative Neoplasm Market Outlook.
[3] IQVIA. (2022). U.S. Prescription Trends and Market Share Data.
[4] FDA. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
[5] EvaluatePharma. (2022). Forecast on Hematology Drugs Market.
