Last updated: March 1, 2026
What Is the Drug Corresponding to NDC 42291-0652?
NDC 42291-0652 refers to Omacetaxine Mepesuccinate (brand name: Synribo). It is a selective protein translation inhibitor approved by the U.S. Food and Drug Administration (FDA) in 2012 for the treatment of chronic myeloid leukemia (CML) in patients resistant or intolerant to tyrosine kinase inhibitors.
Market Overview
Market Size and Incidence
The global CML market is projected to grow from approximately USD 1.5 billion in 2021 to USD 2.3 billion by 2028, at a Compound Annual Growth Rate (CAGR) of 6%. The U.S. accounts for roughly 55% of the global market.
Market Segment for Omacetaxine Mepesuccinate
Omacetaxine Mepesuccinate primarily addresses a niche within the CML treatment landscape—patients resistant to first-line therapies, notably imatinib and subsequent tyrosine kinase inhibitors (TKIs). Its role is confined to the second-line or later settings.
Competitive Landscape
Major competitors include:
- Bosutinib (Bosulif) - Pfizer
- Ponatinib (Iclusig) - Ark Therapeutics
- Dasatinib (Sprycel) - Bristol-Myers Squibb
- Nilotinib (Tasigna) - Novartis
Omacetaxine's use is restricted to specific patient populations, limiting its overall market share relative to broader TKI agents.
Sales Data and Revenue Trends
Since its approval, annual sales have plateaued around USD 50-70 million, constrained by its niche application and limited patient population. The drug's sales are further affected by its administration route (subcutaneous injection) and side effect profile.
Price Dynamics and Projections
Current Pricing
Average wholesale price (AWP) for Synribo is approximately USD 16,000 per 28-day supply, translating to roughly USD 576 per day. The actual price payable by payers is lower, negotiated via rebates and discounts.
Factors Influencing Price Trends
- Market penetration: Limited due to specialized use.
- Patent status: Patent expiry is unlikely within the next five years, maintaining exclusivity.
- Regulatory developments: Any new indications or label expansions could influence pricing.
- Competitive pressure: Slight, due to existing treatments and generics unlikely for this molecule.
Price Projections (2023-2028)
| Year |
Estimated Average Wholesale Price (USD) |
Notes |
| 2023 |
$16,000 |
Current level |
| 2024 |
$15,500 |
Slight price reduction expected from market trends |
| 2025 |
$15,000 |
Competitive pressures may persist |
| 2026 |
$14,500 |
Market stabilization |
| 2027 |
$14,000 |
Pricing stabilization continues |
| 2028 |
$13,500 |
Slight downward trend persists |
Assumption: Prices decline gradually due to negotiated discounts, unchanged patent exclusivity, and the absence of biosimilar or generic competition.
Market Opportunities & Risks
Opportunities
- Label expansion: New indications in other hematologic malignancies could expand usage.
- Combination therapies: Approvals for combination regimens could increase demand.
- Global expansion: Entry into emerging markets with less established CML treatment options.
Risks
- Market saturation: As a niche therapy, the overall market impact remains limited.
- Pricing pressure: Payers could negotiate further discounts or impose formulary restrictions.
- Regulatory shifts: Decreased approval or withdrawal from markets could impact revenues.
Key Takeaways
- NDC 42291-0652 (Omacetaxine Mepesuccinate) is a niche CML therapy with limited but stable demand.
- Current prices are around USD 16,000 per 28-day supply; modest decline projected over five years.
- Market growth depends on label expansions, potential combination therapies, and global adoption.
- Competitive landscape remains stable, with no immediate generic threats.
FAQs
1. What patient population primarily uses Omacetaxine Mepesuccinate?
Patients with chronic myeloid leukemia resistant or intolerant to tyrosine kinase inhibitors.
2. How does the pricing of Omacetaxine compare to other CML treatments?
It is generally more expensive concerning per-treatment costs but used less frequently, affecting overall expenditure.
3. Are there plans for new indications for this drug?
No current FDA-approved expansions, but ongoing research may influence future labeling.
4. What factors could significantly influence the drug’s price in the coming years?
Market penetration, regulatory approvals, competitive pressures, and payer negotiations.
5. Is generic development likely for Omacetaxine?
No, proprietary exclusivity is expected to endure through at least the next five years.
References
- FDA. (2012). Synribo (Omacetaxine Mepesuccinate) Prescribing Information. [Online]
- Grand View Research. (2022). Chronic Myeloid Leukemia Market Size & Trends.
- IQVIA. (2022). U.S. Pharmaceutical Market Data.
- Evaluate Pharma. (2022). Oncology Market Outlook.
[1] U.S. Food and Drug Administration. (2012). Synribo (Omacetaxine Mepesuccinate) Prescribing Information.
