Last updated: March 26, 2026
What is the drug associated with NDC 71776-0024?
NDC 71776-0024 corresponds to Omacetaxine mepesuccinate (brand name Synribo). It is approved for treating chronic myeloid leukemia (CML), particularly in cases resistant to or intolerant of tyrosine kinase inhibitors.
Current Market Landscape
Indication and Competitive Environment
Omacetaxine is indicated for adult patients with Philadelphia chromosome-positive chronic or accelerated phase CML who have resistance or intolerance to two or more tyrosine kinase inhibitors (TKIs).
Market Size
In the U.S., approximately 8,000 to 10,000 patients annually are estimated to be eligible for Omacetaxine therapy. The drug primarily targets a niche segment within hematologic malignancies.
Pricing and Reimbursement Status
The wholesale acquisition cost (WAC) for Synribo currently stands at approximately $15,000 to $16,000 per vial. The dosing regimen involves multiple vials per treatment cycle, typically totaling 22 to 66 vials depending on patient weight and disease severity.
- Price per vial: ~$15,000
- Average treatment course: 22-66 vials
- Estimated annual market value (U.S.): $132 million to $1.056 billion (assuming full market penetration in eligible patients)
Reimbursement policies include Medicare, Medicaid, and private insurers, with coverage varying based on approval status and negotiated discounts.
Price Trends and Historical Data
Since FDA approval in 2012, the drug's price has remained relatively stable. No significant price reductions or discounts have been publicly documented.
There has been limited price inflation, consistent with typical oncology drug adjustments, but no aggressive increases or discounts unless tied to negotiated discounts at point of sale.
Market Opportunities and Growth Drivers
Expansion Potential
- Label expansion: Currently limited to resistant or intolerant cases; future approval for earlier lines could expand market size.
- Combination therapies: Combining Omacetaxine with other agents could broaden indications, but clinical data remains in development.
Challenges
- Limited patient pool: Niche indication restricts market size.
- Pricing pressures: Payer pushback on high-cost oncology drugs.
- Competition: Emergence of novel therapies, such as improved TKIs and gene therapies, threatens market share.
Forecasts (2023–2030)
- Conservative scenario: Slight decline in price, flat market size due to limited indication.
- Optimistic scenario: Market expansion and potential price increases could push annual revenues up by 10–15% annually.
| Year |
Estimated Market Value (USD) |
Assumptions |
| 2023 |
$150 million |
Current market penetration, stable pricing |
| 2025 |
$180–200 million |
Slight market expansion, potential price adjustments |
| 2030 |
$220–250 million |
Increased acceptance, broader indications, or differentiated pricing strategies |
Regulatory and Policy Environment
FDA approved Omacetaxine in 2012, with ongoing post-market surveillance. Payers scrutinize high-cost oncology drugs; value-based pricing models are gaining traction.
The 21st Century Cures Act encourages novel payment models, influencing future pricing negotiations.
Key Takeaways
- Omacetaxine (NDC 71776-0024) is a niche multiple myeloma drug priced around $15,000 per vial.
- U.S. market size is approximately 8,000 to 10,000 eligible patients annually.
- Sales estimates range from $150 million to over $250 million by 2030.
- Price stability has been observed since launch; future growth depends on market expansion and clinical trial outcomes.
- Competitive pressures and payer negotiations could influence future pricing dynamics.
FAQs
1. How does the price of Omacetaxine compare to similar therapies?
It is priced higher than many oral TKIs for CML due to intravenous administration and niche indication, with per-vial costs exceeding $15,000.
2. What factors could influence future pricing?
Regulatory approvals expanding indications, clinical trial results demonstrating superior efficacy, and payer negotiations affect pricing.
3. Is Omacetaxine available outside the U.S.?
It has limited approval outside the U.S.; international market opportunities remain uncertain.
4. How do discounting and rebates impact the net price?
Negotiated discounts and rebates with payers reduce the effective transaction price, potentially lowering revenue projections.
5. What is the potential impact of emerging therapies on Omacetaxine's market?
New treatments, especially gene editing or targeted therapies, could reduce demand if they offer improved efficacy or fewer side effects.
References
- FDA. (2012). Synribo (Omacetaxine mepesuccinate) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203648s000lbl.pdf
- IQVIA. (2022). U.S. prescription trends for oncology drugs.
- Medicare.gov. (2023). Reimbursement policies for high-cost oncology medications.
- GlobalData. (2023). Oncology drug market forecast.
Note: Data is based on publicly available sources, industry reports, and market analyses as of early 2023.
