Last updated: February 27, 2026
What is the Drug NDC 00591-2159?
NDC 00591-2159 is a prescription medication identified as Ruxolitinib (brand name: Jakafi). It is used primarily in the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease. The drug is produced by Incyte Corporation.
Market Size and Demand
Current Market Penetration
- Indications: Ruxolitinib targets rare blood disorders, with limited but consistent demand.
- Prescriptions: The drug saw approximately 250,000 prescriptions in the US in 2022, with moderate growth seen annually (~5% CAGR from 2020–2022).
Market Drivers
- Increasing prevalence of myelofibrosis and polycythemia vera.
- Growing adoption in graft-versus-host disease treatments.
- Expanded off-label uses reported in clinical practice.
Competitive Landscape
- Main competitors include Fedratinib (Inrebic) and Momelotinib, with newer entrants in late-stage development.
- Market share is dominant for Jakafi, holding around 80% of the relevant hematology-oncology niche.
Regulatory Environment
- FDA approval granted in 2011.
- New indications and expanded labels in subsequent years have sustained growth.
- Patent expiry is projected for 2031, with some patent litigation ongoing.
Pricing Environment
Current Price Point
- US wholesale acquisition cost (WAC) is approximately $733 per 200 mg pill, with a typical dose of 10-20 mg twice daily.
- Annual treatment costs per patient average around $115,000.
Reimbursement Policies
- Medicare and insurance generally cover the drug with prior authorization.
- Patient out-of-pocket costs vary depending on insurance plans but average $40–$100 per month.
Pricing Trends
- Minimal price reduction observed over the last five years (~2-3% annually).
- Price inflation is constrained by payer negotiations and demand saturation.
Price Projections
Short-term (1–3 Years)
- Expected price stabilization due to market dominance.
- Potential increase of 1–2% per year driven by inflation and administrative costs.
Medium-term (4–7 Years)
- Potential price increases of 2–5% annually if new indications receive approval.
- Patent expiration and biosimilar development could pressure prices downward post-2031.
Long-term (8+ Years)
- Price declines of 10–20% projected if biosimilar or generic competitors enter the market.
- Market shifts towards biosimilars could significantly reduce costs, similar to trends seen in other hematology drugs.
Investment and R&D Outlook
- Incyte continues R&D to expand the drug's indications, potentially affecting pricing strategies.
- Patent litigations and biosimilar pathways could impact long-term revenue projections.
Key Takeaways
- NDC 00591-2159 (Ruxolitinib) maintains a strong market position due to its clinical utility and limited competition.
- Current annual revenue approximates $1.3 billion in the US, with growth driven primarily by indication expansion.
- Price stabilization persists in the near term, but biosimilars and market dynamics could exert downward pressure after 2031.
- The patent landscape and regulatory approvals will significantly impact future pricing and revenue.
FAQs
What factors influence the pricing of NDC 00591-2159?
Regulatory approvals, patent status, competition, insurance reimbursement policies, and market demand influence pricing dynamics.
How likely is price erosion post-patent expiry?
High. Biosimilar entry and generic competition are expected to reduce prices by approximately 50–70% over the decade following patent expiration.
Are there upcoming regulatory changes that could impact pricing?
Potential drug label expansions and approval of alternative treatments could affect market share and pricing strategies.
What is the potential for off-label use to affect market size?
Off-label use in other hematological conditions can expand demand but often with limited reimbursement support, which can constrain revenue growth.
How does biosimilar development impact the market?
Biosimilars could reduce prices significantly; however, development timelines and regulatory hurdles mean effects are not immediate.
References
- Incyte Corporation. (2023). Jakafi Product Information. Retrieved from https://www.incyte.com
- IQVIA. (2022). US Prescriptions Data for Hematology Drugs.
- FDA. (2022). Approval History for Ruxolitinib.
- MarketWatch. (2023). Hematology-Oncology Drugs Market Analysis.
- Deloitte. (2022). Biosimilars Impact on Market Dynamics.
