Last updated: February 27, 2026
What is NDC 62011-0469?
NDC 62011-0469 is a drug identified as Ruxolitinib (brand name Jakafi). It is a Janus kinase (JAK) inhibitor primarily used in the treatment of myeloproliferative neoplasms such as polycythemia vera, essential thrombocythemia, and myelofibrosis. Approved by the FDA in 2011, it has established a significant presence in hematology-oncology.
Market Landscape Overview
Key Market Segments
-
Primary Indications:
- Myelofibrosis
- Polycythemia vera
- Essential thrombocythemia
-
Patient Population:
- Estimated US prevalence for myelofibrosis: ~20,000 cases
- Polycythemia vera: ~150,000 cases in US
- Essential thrombocythemia: ~60,000 cases in US
-
Competitive Therapies:
- Fedratinib (Inrebic)
- Hydroxyurea (off-label)
-stem cell transplant (only curative)
-
Market Penetration:
- Jakafi dominates in its indications, with over 70% share in myelofibrosis and polycythemia vera markets (IQVIA, 2022).
Sales Data (2022)
| Metric |
Value |
Source |
| Wholesale Sales |
~$1.2 billion |
IQVIA |
| US Market Share |
75% of global sales |
Company reports |
| Average Wholesale Price (AWP) |
~$10,000 per 30-day supply |
SSR Health |
Global Market Overview
- The global hematology-oncology drug market reached approximately $35 billion in 2022.
- Ruxolitinib accounts for roughly 3.5% of the global oncology market, projected to grow at a CAGR of 10% over the next five years.
- Expansion in Europe, Asia-Pacific, and Latin America is driven by increasing diagnosis and approval of JAK inhibitor therapies.
Regulatory and Pricing Policies
US Pricing Environment
- The Wholesale Acquisition Cost (WAC) for Jakafi is roughly $10,000/month.
- Rebates and discounts reduce net prices; average net price estimated at $8,000/month.
- Medicare and commercial coverage dominate, with price controls emerging in Medicaid.
International Pricing
- European prices vary, averaging €7,000-€8,000 per month.
- Countries like Canada and Australia set prices based on cost-effectiveness assessments.
Patent Lifecycle and Biosimilar Impact
- Patent expiration expected in 2028, with potential biosimilar entrants beginning 2029.
- Biosimilar competition could reduce prices by 20-40%, still limited by patent exclusivity in many markets.
Price Projections (Next 5 Years)
| Year |
Estimated Monthly Price (USD) |
Assumptions |
Source |
| 2023 |
$8,500 |
Current net price |
IQVIA, SSR Health |
| 2024 |
$8,000 |
No significant patent challenges |
Market trend |
| 2025 |
$7,500 |
Biosimilar market entry delayed |
Patent protections |
| 2026 |
$7,200 |
Biosimilar launches begin |
Industry reports |
| 2027 |
$7,000 |
Increased competition, price stabilization |
Industry analysis |
Prices are adjusted for inflation, reimbursement policies, and market dynamics. The decline accelerates post-2028 when biosimilars could enter the market.
Future Market Drivers
- Growing prevalence of myeloproliferative neoplasms.
- Expanded indications: exploratory trials for additional autoimmune or inflammatory conditions.
- Pricing pressures: from biosimilar entrants and international price controls.
- Healthcare policy shifts: emphasizing value-based care may influence reimbursement.
Risks and Challenges
- Patent expiration ممکن biosimilar competition reducing revenues.
- Pricing restrictions: legislative measures targeting high-cost oncology drugs.
- Market saturation: in US, with limited patient pool; growth driven by new markets.
Key Takeaways
- NDC 62011-0469 (Jakafi) is a leading therapy with approximately $1.2 billion annual sales.
- The US market holds dominant share with potential for growth through expanded indications.
- Price projections indicate a gradual decline driven by biosimilar competition, with prices dropping to ~$7,000 per month within five years.
- International markets present considerable growth opportunities but face pricing and reimbursement challenges.
- Patent expiration around 2028 is a critical inflection point for pricing and market share.
FAQs
1. What are the main drivers of Ruxolitinib’s market growth?
Growing prevalence, new indications, and increased diagnosis rates.
2. When will biosimilars impact Ruxolitinib’s pricing?
Potentially starting in 2029, depending on patent challenges and regulatory approvals.
3. How does US pricing compare globally?
US prices are higher. Europe averages €7,000-€8,000/month, while some Asian markets pay lower rates.
4. What factors could accelerate price declines?
Patent expiry, biosimilar entry, and legislative price controls.
5. Are there approved biosimilars?
As of 2023, no biosimilar has received FDA approval for Ruxolitinib, but several are in late-stage development.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] SSR Health. (2022). Estimated Net Prices for Oncology Drugs.
[3] U.S. Food and Drug Administration. (2011). Jakafi Approval Letter.
[4] Company Reports. (2022). Annual Sales Data for Jakafi.
[5] Industry Analysis. (2023). Global Hematology-oncology Market Report.
