Last updated: February 23, 2026
What is NDC 51407-0252?
NDC 51407-0252 identifies the drug Ruxolitinib (brand name Jakafi), indicated primarily for myelofibrosis, polycythemia vera, and graft-versus-host disease. It is a JAK1/JAK2 inhibitor developed by Incyte Corporation and approved by the FDA in 2011.
Market Overview
Market Size and Growth
The global myelofibrosis market, driven by the use of ruxolitinib, was valued at approximately USD 1.2 billion in 2021. It is expected to grow at a compound annual growth rate (CAGR) of 8-10% through 2030, driven by increasing prevalence and expanding indications.
Indications and Usage
- Myelofibrosis (MF): Approved in 2011, with the latest update expanding to untreated MF patients.
- Polycythemia Vera (PV): Approved in 2019.
- Graft-versus-host disease (GVHD): Approved in 2021 as a treatment for steroid-refractory cases.
Competitive landscape
Major competitors include other JAK inhibitors such as Fedratinib (Incyte), Momelotinib (pending approval), and emerging therapies targeting other pathways.
Pricing History
- Initial wholesale acquisition cost (WAC) ranged from USD 15,000 to USD 20,000 per month.
- Incyte maintains a premium pricing strategy based on the drug's patent exclusivity and clinical efficacy.
Price Projections
Current Pricing
As of early 2023, ruxolitinib (Jakafi) is priced at approximately USD 17,500 per month (WAC), equating to USD 210,000 annually. The price varies by dosage form and patient weight.
Future Price Trends
Projection assumes continued patent protection until at least 2028, with potential price stabilization. Post-patent expiration, biosimilars and generics are likely to enter the market, reducing prices by 50-70%.
| Year |
Estimated Price per Year |
Rationale |
| 2023 |
USD 210,000 |
Current price; no significant changes. |
| 2025 |
USD 200,000 |
Slight reduction forecast due to negotiations. |
| 2028 |
USD 150,000 |
Patent expiry approaches; biosimilars introduced. |
| 2030 |
USD 100,000 |
Increased generic competition depresses prices. |
Cost-Market Dynamics
Pricing will be influenced by:
- Patent status: Protection until 2028.
- Reimbursement policies: Insurance and Medicare negotiations.
- Market penetration: Expansion into new indications or countries.
- Biosimilar development: Entry post-2028, expected to drive prices down.
Regulatory and Patent Considerations
- Patent expirations: Composition-of-matter patent held until 2028, with newer patents on formulations and methods extending to 2030.
- Regulatory approvals: Expanding indications can sustain higher prices longer.
- Orphan drug designation: Provides market exclusivity until 2028, delaying biosimilar entry.
Key Takeaways
- NDC 51407-0252 (ruxolitinib) is a high-value, niche oncology drug with current annual revenues exceeding USD 200 million.
- The market is expected to grow modestly at 8-10% CAGR until patent expiration.
- Prices are projected to decline significantly with biosimilar competition post-2028.
- Pricing strategies depend on patent status, reimbursement negotiations, and market expansion.
- Future developments may include new indications or formulations, potentially impacting pricing stability.
FAQs
-
When does the patent for NDC 51407-0252 expire?
Patent protections for Jakafi are valid until 2028, after which biosimilar competition is expected.
-
What are the main drivers for price reduction post-2028?
Biosimilar entry, increased competition, and payer pressure.
-
Are there approved biosimilars or generics for ruxolitinib?
No approved biosimilars or generics as of early 2023; biosimilar development is ongoing.
-
What are key factors influencing market growth?
Expansion into new indications, geographic expansion, and regulatory approvals.
-
How do reimbursement policies affect pricing?
Payer negotiations can lead to discounts or value-based pricing agreements.
References
[1] Incyte Corporation. (2023). Jakafi (ruxolitinib) prescribing information.
[2] MarketWatch. (2022). Myelofibrosis drugs market size and forecast.
[3] U.S. Food and Drug Administration. (2022). FDA approvals for myelofibrosis and PV.
[4] Evaluate Pharma. (2022). Oncology drug market forecasts.
[5] Patent and Trademark Office. (2022). Patent expiration dates for Jakafi.
