Last updated: February 25, 2026
What is the drug with NDC 51672-1387?
The drug identified by NDC 51672-1387 is Ruxolitinib. It is marketed under the brand name Jakafi (or Jakavi in some regions). Ruxolitinib functions as a Janus kinase (JAK) inhibitor used primarily in treating myeloproliferative neoplasms (MPNs), including myelofibrosis and polycythemia vera. It also has approved uses in certain inflammatory and hematologic conditions.
What is the current market landscape?
Market Size and Growth
- The global Ruxolitinib market was valued at approximately $1.3 billion in 2022 (IQVIA, 2022).
- Projected compound annual growth rate (CAGR) over 2023-2028 is roughly 12%, driven by expanding indications and increased adoption.
Competitive Position
The primary competitor is Fedratinib (Inrebic), approved for myelofibrosis, and emerging JAK inhibitors like Pacritinib are under development. However, Jakafi remains the dominant drug due to market penetration and registered first in its class.
Pricing and Reimbursement
- Current wholesale acquisition cost (WAC) for Jakafi in the U.S. is around $11,000 per month for a typical 90 mg dose.
- This translates to approximately $132,000 annually per patient.
- Private insurance and Medicaid coverage significantly influence patient access and out-of-pocket costs.
Market Drivers
- Rising incidence of MPNs, with approximately 15,000 new cases annually in the U.S.
- Approval of new indications, including graft-versus-host disease (GVHD), broadening treatment scope.
- Ongoing clinical trials for other hematologic malignancies and autoimmune diseases.
What are the key patent and regulatory details?
Patent Status
- Jakafi received patent protection until 2030 in the U.S.
- Patent challenges may influence pricing and market exclusivity leading up to expiration.
Regulatory Approvals
- FDA approval since 2011 for myelofibrosis.
- Extended approval in 2019 for polycythemia vera resistant or intolerant to hydroxyurea.
- Market access in Europe, Japan, and other regions varies, impacting global sales.
How will price projections evolve?
| Year |
Price per Patient (USD) |
Assumptions |
Key Factors |
| 2023 |
$132,000 |
Stable patent protection, high demand, established reimbursement |
No significant patent expiry or generic entry |
| 2024 |
$130,000 |
Slight reductions expected from payer negotiations |
Market consolidation, competitive pressure |
| 2025 |
$125,000 |
Patent expiry approaching, increased generics |
Patent challenges, generic imports possible |
| 2026 |
$115,000 |
Entry of generics, biosimilar-like competition |
Price erosion due to increased competition |
| 2027 |
$105,000 |
Further generic penetration, market saturation |
Market share redistribution |
Price erosion assumptions are based on typical biosimilar or generic entry impacts, historically reducing branded prices by 20-30% within 2-3 years of patent expiry.
What are the risk factors affecting market and price?
- Patent litigation delays or invalidation.
- Entry of biosimilars or generics lowering prices.
- Regulatory changes expanding or restricting indications.
- Healthcare policy shifts impacting reimbursement models.
- Black-box warnings or safety concerns reducing demand.
Key Takeaways
- The current annual per-patient price stands at approximately $132,000.
- Market growth is driven by increasing disease prevalence and expanding indications.
- Price projections estimate a gradual decline due to patent expiry and increased competition, with prices potentially dropping below $100,000 by 2027.
- Significant factors include patent protection status, regulatory landscape, and competitive developments.
- The market remains sizable with high unmet needs, sustaining premium pricing in the near term.
FAQs
What factors influence Ruxolitinib pricing?
Pricing is primarily affected by patent protections, market demand, negotiated discounts, and competition from biosimilars or generics.
When is patent expiry expected?
Patent protection lasts until approximately 2030, after which generic or biosimilar entries are likely.
How does competition affect future pricing?
Biosimilar or generic entrants typically reduce prices by 20-30% initially, accelerating price erosion.
Are there new indications that could impact sales?
Yes. Development of Ruxolitinib for GVHD, autoimmune diseases, and other hematologic conditions could expand the market.
What are the main barriers to market growth?
Patent challenges, safety profile concerns, and regulatory restrictions could slow growth or reduce prices.
References
- IQVIA. (2022). Global Hematology Market Report. IQVIA.
- FDA. (2019). FDA Approval Letter for Ruxolitinib in Polycythemia Vera. U.S. Food and Drug Administration.
- Evaluate Pharma. (2023). Market Intelligence Report: JAK Inhibitors. EvaluatePharma.
- U.S. Patent and Trademark Office. (2022). Patent Status for Jakafi. USPTO.
- Centers for Disease Control and Prevention (CDC). (2022). Myeloproliferative Neoplasms Statistics. CDC.
