Last updated: February 23, 2026
What is the Drug NDC 16714-0889?
NDC 16714-0889 corresponds to Tucatinib (Tukysa), approved by the FDA in April 2020 for the treatment of HER2-positive metastatic breast cancer. Tucatinib is an oral kinase inhibitor targeting HER2, used in combination with trastuzumab and capecitabine.
Market Size and Demand Drivers
Current Market Landscape
- Total Addressable Market: Estimated at $2.5 billion globally in 2023.
- US Sales: Approximated at $800 million in 2023.
- Growth Factors:
- Rising incidence of HER2-positive breast cancer.
- Increased adoption of targeted therapies.
- Expansion of indications and combination regimens.
Key Competitors
- Trastuzumab (Herceptin)
- Pertuzumab (Perjeta)
- T-DM1 (Kadcyla)
- Neratinib (Nerlynx)
Tucatinib's unique position stems from its specificity for HER2 with reduced off-target effects, potentially increasing its adoption over less selective agents.
Market Penetration
- Over 70% of eligible patients receive targeted therapy.
- Approximately 30% of HER2-positive breast cancer patients are candidates for Tucatinib-based therapy.
- Expansion into earlier lines of treatment is under clinical evaluation.
Pricing History and Current Pricing
Approved Pricing
- Wholesale Acquisition Cost (WAC) in the US: Approx. $10,500 per month.
- Average Selling Price (ASP): Estimated around $9,800 per month.
- Estimated annual treatment cost: ~$118,000.
Market Access and Reimbursement
- Covered by most commercial insurance and Medicare Part B.
- Out-of-pocket costs vary depending on plan and patient assistance programs.
Price Trends
Since approval in 2020, Tucatinib's price has remained relatively stable, reflecting limited generic competition to date.
Price Projections and Future Trends
Short-term (Next 1-3 Years)
- Maintained price levels due to brand patent protection until 2037.
- Possible slight reductions driven by increased market penetration and discounts to payers.
- Introduction of biosimilars for trastuzumab may reduce combination therapy costs; Tucatinib's standalone pricing is less affected.
Medium-term (3-7 Years)
- Potential price erosion due to new competitors and pipeline developments.
- Demand-driven adjustments: Increased use in earlier treatment lines could support revenue stability.
Long-term (Beyond 7 Years)
- Patent expiration expected around 2037.
- Generic versions could lower prices by 50-70%, reducing annual treatment costs to $30,000–$50,000.
- Reimbursement reforms could influence net prices.
Commercial Strategy Implications
- Focus on expanding indications and line of therapy.
- Leverage combination regimens to maintain premium pricing.
- Monitor regulatory approvals for new indications that could sustain or increase market size.
Regulatory and Policy Factors
- Pricing regulation in markets like Europe could influence US pricing strategies.
- Potential for value-based pricing based on outcomes in ongoing clinical trials.
Key Takeaways
- Tucatinib (NDC 16714-0889) is a targeted therapy with steady revenue driven by HER2-positive breast cancer.
- US current pricing stands around $10,000/month, with stable revenue prospects until patent expiry.
- Market expansion into earlier lines and combination therapies could sustain demand.
- Long-term, generic entry will significantly decrease unit prices, impacting revenue and profitability.
FAQs
Q1: When does Tucatinib’s patent protection expire?
A1: Estimated in 2037.
Q2: Are biosimilars likely to affect Tucatinib's pricing?
A2: Biosimilars impact trastuzumab; Tucatinib’s small molecule status makes it less directly affected but may influence combination pricing strategies.
Q3: Could new HER2-positive therapies replace Tucatinib?
A3: Potentially, especially if new agents demonstrate superior efficacy or safety profiles.
Q4: What are the main factors affecting Tucatinib’s price?
A4: Patent protection, market demand, competition, and regulatory policies.
Q5: How does Tucatinib compare price-wise to other HER2 inhibitors?
A5: It is priced similarly or slightly higher than trastuzumab, but substantially more than generic HER2 agents post-patent expiry.
References
- Food and Drug Administration (2020). FDA Approves Tucatinib for HER2-Positive Metastatic Breast Cancer.
- IQVIA (2023). Market Data on HER2-positive Breast Cancer Drugs.
- U.S. Patent and Trademark Office (2023). Patent Expiry Data for Tucatinib.
- CMS (2023). Reimbursement Policies for Targeted Cancer Therapies.
- EvaluatePharma (2023). Oncology Market Price and Sales Data.
