Last updated: February 25, 2026
What is the Drug Associated with NDC 42806-0097?
NDC 42806-0097 corresponds to Tucatinib (Cyramza, generic), marketed primarily as a targeted therapy for HER2-positive cancers. It is an oral tyrosine kinase inhibitor approved by the FDA in April 2020 for treating HER2-positive metastatic breast cancer, combined with trastuzumab and capecitabine.
Market Size and Growth Drivers
Market Overview
The HER2-positive breast cancer market is driven by approximately 20,000 new cases annually in the U.S., with targeted therapies capturing a significant financial share. Tucatinib competes with established drugs such as trastuzumab, pertuzumab, and ado-trastuzumab emtansine and is positioned for use in combination regimens.
Key Market Segments
- HER2-positive metastatic breast cancer: The primary segment where tucatinib is prescribed.
- Post-trastuzumab therapy: Patients progressing after initial HER2-targeted treatment.
- Combination treatments: Tucatinib is often used with trastuzumab and capecitabine.
Competitive Landscape
| Drug |
Approval Year |
Indications |
Annual Sales (2022) |
Market Share (%) |
| Trastuzumab (Herceptin) |
1998 |
HER2-positive breast cancer |
$4.2 billion |
45 |
| Ado-trastuzumab emtansine |
2013 |
Metastatic HER2-positive breast cancer |
$3.2 billion |
35 |
| Pertuzumab (Perjeta) |
2012 |
HER2-positive breast cancer |
$2.1 billion |
10 |
| Tucatinib (Cyramza) |
2020 |
HER2-positive metastatic breast cancer |
~$300 million (2022est) |
5 |
Market Growth Drivers
- Rising adoption of combination therapies.
- Expanding indications to earlier lines.
- Increased diagnosis rates of HER2-positive subtypes.
- Demonstrated efficacy in brain metastases, a high-unmet need.
Market Risks
- Competition from biosimilars.
- Pricing pressures and reimbursement policies.
- Potential off-label use or emerging therapies.
Price Analysis and Projections
Current Pricing
| Parameter |
Estimated Price (2023) |
Description |
| Wholesale Acquisition Cost (WAC) |
$8,500 per 30-day supply |
Reflects list price before discounts. |
| Average Selling Price (ASP) |
$7,200 per 30 days |
Typical paid price after discounts and rebates. |
| Patient Out-of-Pocket Cost |
$50–$300 per month |
Varies based on insurance coverage. |
Pricing Benchmarking
Compared to other HER2 therapies, tucatinib's daily cost positions it competitively:
- Trastuzumab: Approximately $2,500 per infusion.
- Ado-trastuzumab emtansine: ~$9,000 per dose.
- Pertuzumab: ~$4,000 per infusion.
Oral administration grants potential price advantages over infusion-based agents but is mitigated by patent protections and high clinical demand.
Future Price Projections (2023–2028)
| Year |
Estimated WAC Price |
Rationale |
| 2023 |
$8,500 |
Current list price, no major changes. |
| 2024 |
$8,400 |
Slight decrease from rebates, patent continuation. |
| 2025 |
$8,200 |
Possible generic entry for earlier line patents. |
| 2026 |
$7,900 |
Increased biosimilar competition, patent expirations. |
| 2027 |
$7,600 |
Continued pricing pressure, potential introduction of biosimilars. |
| 2028 |
$7,400 |
Market normalization with biosimilar options. |
Key Factors Influencing Price Changes
- Patent expiry in 2028 grants potential for biosimilar entry.
- Reimbursement policies may restrict prices.
- Market penetration and off-label use can expand volume but not necessarily price.
Strategic Implications
- The small market share and high per-unit cost indicate price sensitivity.
- Expansion into adjuvant settings or early line therapies could sustain revenue but face regulatory and clinical challenges.
- Competitive pressures from biosimilars likely reduce profits post-patent expiration.
Summary
NDC 42806-0097 (tucatinib) maintains a niche in treating HER2-positive metastatic breast cancer. The drug's current pricing remains stable but is vulnerable to generic competition starting around 2028. Market growth depends on expanding indications, clinical adoption, and biosimilar development.
Key Takeaways
- The U.S. HER2-positive breast cancer drug market is approaching $10 billion annually.
- Tucatinib's 2022 sales are approximately $300 million, with growth driven by combination therapy adoption.
- The current list price is around $8,500 per month, with reimbursement significantly reducing patient costs.
- Patent expiration in 2028 could trigger biosimilar entry, reducing prices by approximately 10–15% annually.
- Market expansion hinges on clinical efficacy, labeling updates, and competitive dynamics.
FAQs
Q1: When does tucatinib's patent expire?
A1: Patent protection in the U.S. is expected to expire around 2028, opening the market to biosimilar competition.
Q2: What are the major competitors to tucatinib?
A2: Trastuzumab, pertuzumab, and ado-trastuzumab emtansine are the primary competitors, with some overlapping indications.
Q3: How does tucatinib's oral formulation impact market pricing?
A3: Oral administration reduces healthcare delivery costs, allowing for potentially lower prices than infusion therapies and improving patient convenience.
Q4: What factors could influence blistering market share for tucatinib?
A4: Clinical efficacy, safety profile, regulatory approvals for new indications, and competitive biosimilar entry.
Q5: Are there upcoming regulatory or clinical milestones for tucatinib?
A5: Potential label expansions and combination therapy approvals could enhance market positioning; none are currently scheduled for 2023–2024.
References:
- U.S. Food and Drug Administration (2020). FDA approves tucatinib for HER2-positive metastatic breast cancer.
- IQVIA. (2022). U.S. Oncology Market Report.
- EvaluatePharma. (2023). Oncology drug market forecasts.
- NCCN Clinical Practice Guidelines in Oncology. (2023). HER2-positive breast cancer management.
- FactSet. (2023). Pharmaceutical pricing benchmarks.
