Last updated: February 13, 2026
What is the Drug NDC 00187-5172?
NDC 00187-5172 corresponds to Ruxolitinib, marketed as Jakafi. It is a Janus kinase (JAK) inhibitor approved for myelofibrosis, polycythemia vera, and graft-versus-host disease (GVHD).
Market Overview
Therapeutic Area and Market Size
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The myelofibrosis segment in hematology-oncology has an estimated global market of approximately USD 1.2 billion in 2022, with projections to reach USD 1.75 billion by 2027 (IQVIA).
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Polycythemia vera is a niche but growing segment, with a market of roughly USD 150 million in 2022, expected to increase marginally.
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GVHD treatment, driven by rising allogeneic hematopoietic stem cell transplants, has around USD 300 million in annual sales for JAK inhibitors as a class, including Jakafi.
Competitive Landscape
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Main competitors include Fedratinib (Inrebic), Pacritinib, and off-label use of other JAK inhibitors like Baricitinib and Tofacitinib.
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Patent exclusivity in the U.S. extends until at least 2026, with potential for extended data exclusivity due to orphan drug designation.
Market Drivers
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Increasing diagnosis rates for myeloproliferative neoplasms due to better detection.
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Growing awareness of JAK inhibitors as first-line or second-line treatments.
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Ongoing expansion into GVHD, with clinical trials indicating promising efficacy.
Key Regulatory Developments
Price Analysis
Current Pricing
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Average wholesale price (AWP): Approximately USD 1,600 per 200 mg tablet.
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Monthly treatment cost: For a typical dose (e.g., 20 mg twice daily), the cost is around USD 7,200.
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Patient access programs and rebates: Significantly reduce net prices for payers and patients.
Comparative Pricing
| Drug |
Indication |
Approximate Monthly Cost |
Patent Status |
| Jakafi (Ruxolitinib) |
Myelofibrosis, PV, GVHD |
USD 7,200 |
Patent until 2026+ |
| Inrebic (Fedratinib) |
Myelofibrosis |
USD 6,500 |
Patent until late 2020s |
| Pacritinib (investigational) |
Myelofibrosis |
Data not available |
Under clinical trial |
Pricing Trends and Forecasts
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Price currently stabilizes within USD 1,600–1,800 per month for branded formulations.
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Projected stability through 2025 with potential slight declines due to biosimilar entry or competitive pressures.
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Biosimilar options likely to enter 2026-2027, potentially reducing prices by 20–30%.
Market Outlook and Price Projections (2023–2027)
| Year |
Estimated Market Size |
Expected Price per Month |
Factors Influencing Price |
| 2023 |
USD 1.65 billion |
USD 7,200 |
Patent exclusivity holds |
| 2024 |
USD 1.70 billion |
USD 7,000–7,200 |
Insurance negotiations, rebates |
| 2025 |
USD 1.75 billion |
USD 6,800–7,000 |
Increased competition, label expansions |
| 2026 |
USD 1.85 billion |
USD 6,000–6,800 |
Patent expiry, biosimilar entry |
| 2027 |
USD 1.90 billion |
USD 5,800–6,500 |
Biosimilar market stabilization |
Impact of Biosimilars and Generics
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Biosimilars for ruxolitinib scheduled for approval post-2026, likely decreasing prices.
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Anticipated 20–30% price reduction upon biosimilar availability.
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Rebates, copay assistance, and payer negotiations further impact net pricing.
Key Takeaways
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Ruxolitinib (NDC 00187-5172) commands high annual treatment costs (~USD 86,400 per patient) in the US.
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The market size exceeds USD 1.7 billion, driven by approvals for multiple indications.
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Competition from direct alternatives and biosimilars will influence future pricing.
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Patent protections and regulatory exclusivity extend until at least 2026, constraining generics.
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Price reductions are likely post-2026 due to biosimilar entry, but current prices remain high due to patent protections and market demand.
FAQs
1. What is the primary approved use for NDC 00187-5172 (Ruxolitinib)?
It is approved for myelofibrosis, polycythemia vera (PV), and graft-versus-host disease (GVHD).
2. How does the pricing of Jakafi compare with competitors?
Jakafi’s monthly treatment cost is around USD 7,200, higher or comparable with other JAK inhibitors, which range from USD 6,500 to USD 7,300.
3. When are biosimilars likely to enter the market?
Post-2026, following patent expiry and FDA biosimilar pathway approvals.
4. What factors could influence the price decline?
Patent expiration, biosimilar competition, payer negotiations, and market saturation.
5. What is the projected market growth for ruxolitinib?
The market is expected to grow at a CAGR of approximately 4.5%, reaching USD 1.9 billion by 2027.
References
[1] IQVIA, "Hemato-Oncology Market Analysis," 2022.
[2] U.S. Food and Drug Administration, "Jakafi Approval and Labeling," 2019.
[3] Evaluate Pharma, "Global Hematology Market Projections," 2022.
[4] U.S. Patent and Trademark Office, "Patent Status for Ruxolitinib," 2022.
