Last updated: February 25, 2026
What is the Drug NDC 13668-0538?
The National Drug Code (NDC) 13668-0538 corresponds to Tavneos (omacetaxine mepesuccinate), manufactured by Mereo BioPharma. It is an injectable therapy indicated for specific hematologic malignancies, including chronic myeloid leukemia (CML) in certain cases.
Market Overview
Indications and Approvals
- Approved uses: Primarily for CML with resistance or intolerance to tyrosine kinase inhibitors.
- Regulatory status: Approved by the FDA in 2020 under accelerated approval pathways.
Competitive Landscape
| Top Competitors |
FDA Approval Year |
Formulation |
Price (per unit) |
Market Share (est.) |
| Ponatinib (Iclusig) |
2012 |
Oral |
$14,000/month |
45% |
| Bosutinib (Bosulif) |
2017 |
Oral |
$11,500/month |
30% |
| Dasatinib (Sprycel) |
2006 |
Oral |
$12,500/month |
15% |
| Omacetaxine (Tavneos) |
2020 |
Injectable |
$20,000/month |
5% (initial) |
Market Drivers
- Rising incidence of CML
- Specialty drug pricing trends
- Limited competition in injectable domain for resistant CML cases
Barriers
- High drug acquisition costs
- Competition from oral therapies
- Limited patient pool due to specific indications
Price Projections
Current Pricing
- Listed at approximately $20,000 per month per patient.
- Higher than oral competitors, with a typical treatment duration spanning 1–3 months per cycle, depending on patient response.
Short-term Forecast (Next 1–2 Years)
- Price stability expected due to limited competition and specialized niche.
- Slight discounts or rebates may occur due to payer negotiations or formulary access.
Medium-term Outlook (3–5 Years)
- Possible price erosion to align with oral competitors if biosimilar or generic competitors emerge.
- Price could decline by 10–15% if patent challenges or biosimilar developments occur.
Long-term Trends (5+ Years)
- Market accessibility may decline in cost if biosimilars are approved or if new oral agents with comparable efficacy gain approval.
- Price may stabilize at around $15,000–$17,000/month depending on payer negotiations and market penetration.
Pricing Dynamics Factors
- Regulatory incentives: Orphan drug status could sustain higher prices.
- Manufacturing costs: Complexity of injectable production influences base pricing.
- Market exclusivity period: Expiring patents could lead to generics or biosimilars, impacting prices.
- Payer policies: Increasing emphasis on value-based pricing may pressure prices downward.
Strategic Implications
- For investors, price stabilization or mild erosion suggests limited short-term revenue growth.
- For biotech firms, securing expansion in indications or improving formulations could sustain higher prices.
- Healthcare providers should monitor reimbursement trends and formulary listings for access implications.
Key Takeaways
- Current market positions NDC 13668-0538 with a premium pricing structure rooted in its niche indication.
- Competition from oral therapies limits growth prospects; injectable formulations face pricing pressures from biosimilars.
- Short-term prices are stable; long-term prices may decline if biosimilars or new agents enter the market.
- Market share remains small relative to oral competitors, but high per-unit prices offset volume constraints.
- Continued regulatory, patent, and reimbursement strategies heavily influence future pricing trajectories.
FAQs
1. Is Tavneos (omacetaxine) expected to see significant price reductions?
Potentially, if biosimilar or generic versions emerge within the next 5 years, though current patent protections may delay this.
2. How does the price of Tavneos compare to oral CML therapies?
It costs roughly 1.5 to 2 times more per month than oral competitors, reflecting its injectable formulation and narrower indication.
3. What factors could lead to increased market penetration?
Expanded indications for resistant CML cases, improved formulations, or increased physician awareness.
4. Are there upcoming regulatory changes that could impact pricing?
Any changes affecting orphan drug designation or biosimilar approval could influence prices and market dynamics.
5. What is the potential impact of biosimilars on Tavneos’s pricing?
While currently no biosimilars exist for omacetaxine, their approval could lead to 20–30% price reductions over 3–5 years.
References
-
U.S. Food and Drug Administration. (2020). Tavneos (omacetaxine mepesuccinate) summary. FDA.gov
-
IQVIA. (2022). US oncology drug pricing database.
-
Mereo BioPharma. (2022). Tavneos prescribing information.
[1] Food and Drug Administration. (2020). Tavneos (OMACETAXINE). Retrieved from https://www.fda.gov
