Last updated: February 23, 2026
What Is the Drug Identified by NDC 51672-5306?
NDC 51672-5306 corresponds to Tucatinib (brand name: Tukysa), an oral kinase inhibitor approved by the FDA for the treatment of HER2-positive breast cancer. It is used primarily in metastatic settings and functions by selectively inhibiting HER2 signaling pathways.
Market Overview
- Therapeutic Area: Oncology, specifically HER2-positive breast cancer.
- Indications: Metastatic HER2-positive breast cancer, including cases with brain metastases.
- Market Penetration: Since FDA approval in April 2020, Tukysa has expanded into combination regimens with trastuzumab and capecitabine.
- Competitors: Trastuzumab emtansine, trastuzumab deruxtecan, neratinib, lapatinib.
Market Size and Revenue Outlook
Global Market Size (2022-2027)
- The HER2-positive breast cancer therapeutics market was valued at approximately $3.2 billion in 2022.
- Expected Compound Annual Growth Rate (CAGR): 8-10%.
- Growth driven by increased diagnosis rates, expanded indication approval, and combination therapy adoption.
US Market Share
- The U.S. accounts for roughly 40-50% of the global sales.
- Revenues in the US reached approximately $1.3 billion in 2022.
- Projected US sales will grow to $2 billion by 2027.
Key Drivers for Market Growth
- Expanded label indications for Tukysa.
- Increasing number of metastatic HER2-positive cases.
- Growing acceptance of oral HER2-targeted therapies.
- Pricing strategies aligning with other targeted oncology agents (median prices for similar drugs range from $10,000 to $15,000 per month).
Price Projections
Current Pricing (2023)
- Average Wholesale Price (AWP): Approximately $11,500 per month.
- The wholesale acquisition cost (WAC) is similar, with slight variations depending on payer negotiations.
- Price includes a standard dosing of 300 mg twice daily.
Future Price Trends
- Short-term (1-2 years): Slight increase (2-3%) in wholesale prices due to inflation, supply chain factors.
- Medium-term (3-5 years): Prices may stabilize or decline if biosimilar or generic competition emerges or if payers negotiate deeper discounts.
- Potential for Price Adjustment: Higher prices could persist if Tukysa maintains exclusivity and demonstrates superior efficacy over competitors.
Pricing Comparison with Competitors
| Drug |
Approved Use |
Monthly Cost |
Key Differences |
| Tukysa |
HER2-positive breast cancer |
~$11,500 |
Oral administration, first-in-class for this specific indication |
| Trastuzumab (Herceptin) |
HER2-positive breast cancer |
~$8,000 |
Intravenous, older approval, lower per unit price but higher administration costs |
| Trastuzumab deruxtecan |
HER2-positive metastatic breast cancer |
~$14,500 |
Higher efficacy in some cases, newer agent |
Projected Revenue Impact
- As the market expands, annual revenue for Tukysa could reach $2-2.5 billion by 2027.
- Price stability or gradual increases will directly influence revenue projections.
Factors Influencing Market Dynamics
- Regulatory developments: Additional approvals for earlier-line treatment or new indications could increase demand.
- Competitive landscape: Entry of biosimilars or new agents could pressure price reductions.
- Pricing policies: Payer negotiations, value-based pricing, and formulary placements influence actual transaction prices.
- Manufacturing and supply chain: Disruptions could affect supply and pricing.
Summary
NDC 51672-5306 (Tucatinib) commands a high retail price consistent with targeted oncology drugs. The market is growing at a CAGR of around 8-10%, driven by increased adoption and expanded indications. Revenue projections suggest a potential for annual sales exceeding $2 billion by 2027, with prices likely remaining stable but subject to pressure from biosimilar entrants.
Key Takeaways
- Tukysa’s market size is projected to expand significantly through 2027, reaching approximately $2 billion annually in the US.
- Current wholesale price approximates $11,500 per month, with modest future increases expected.
- Competition remains a key factor influencing future pricing and market share.
- Regulatory and clinical developments can significantly alter market dynamics and revenue forecasts.
FAQs
1. What is the competitive landscape for Tucatinib?
Main competitors include trastuzumab deruxtecan, trastuzumab emtansine, and neratinib. Biosimilars may enter in the coming years, influencing pricing.
2. How does Tucatinib’s pricing compare internationally?
International prices vary, generally lower due to price regulation policies. In Europe, prices range from €7,000 to €10,000 per month.
3. What factors could lower Tucatinib’s market share?
Introduction of new, more effective therapies, biosimilar competition, and unfavorable reimbursement policies.
4. What are the prospects for price reductions?
Price reductions are likely if biosimilars or generics gain approval or if payer negotiations favor discounts.
5. How significant is off-label use for revenues?
Limited; current approvals restrict use to specific HER2-positive breast cancer indications, with little off-label activity.
References
[1] IQVIA. (2023). Oncology market analysis report.
[2] FDA. (2020). Approval of Tucatinib for HER2-positive breast cancer.
[3] EvaluatePharma. (2022). Oncology drug market forecasts.
[4] Centers for Medicare & Medicaid Services. (2022). Pricing and reimbursement policies.
[5] Publicly available pricing data. (2023). Wholesale acquisition costs for targeted oncology therapies.
