Last updated: March 3, 2026
What is NDC 71288-0451?
NDC 71288-0451 refers to Tucatinib (Ulotinib), marketed by Seattle Genetics. It is an oral tyrosine kinase inhibitor approved in April 2020 for treatment of unresectable or metastatic HER2-positive breast cancer, in combination with trastuzumab and capecitabine. The drug's approval is based on the HER2CLIMB trial, which showed improved progression-free survival and overall survival.
Market Landscape
Target Indications
- HER2-positive metastatic breast cancer
- Approved specifically for patients who have received at least two prior anti-HER2-based regimens in the metastatic setting
Competitive Environment
| Drug Name |
Approval Year |
Indication |
Sales (2022) |
Market Share (Estimate) |
| Tucatinib (NDC 71288-0451) |
2020 |
HER2-positive breast cancer |
~$60 million |
15-20% |
| Trastuzumab (Herceptin) |
1998 |
HER2-positive breast cancer |
~$2 billion |
50-60% |
| Neratinib (Nerlynx) |
2017 |
HER2-positive breast cancer |
~$180 million |
10-15% |
Tucatinib's sales are lower but growing, driven by increasing adoption in its niche population. It faces competition from trastuzumab-based therapies and other HER2 inhibitors.
Pricing Overview
- Average Wholesale Price (AWP): Approximately $15,000 - $17,000 per month
- Average Selling Price (ASP): Estimated at $14,000 - $16,000 per month
- Annual Cost: Approximate $168,000 - $192,000 per patient
Pricing factors include the drug's novelty, market penetration, competitive pricing, payer negotiations, and the treatment algorithm.
Reimbursement and Payer Dynamics
- Clinical efficacy favoring Tucatinib has driven favorable reimbursement in commercial and Medicare Part B environments.
- Historical trend indicates initial high pricing with moderate discounts through formulary negotiations.
Market Potential and Forecasts
Demand Drivers
- Rising prevalence of HER2-positive breast cancer globally
- Earlier adoption in combination therapies
- Expansion of indications to earlier treatment lines
Market Size Estimates
| Year |
Estimated Patients (U.S.) |
Global Market Size (USD) |
| 2022 |
20,000 |
~$3.0 billion |
| 2025 |
30,000 |
~$4.5 billion |
| 2030 |
45,000 |
~$6.8 billion |
Assumptions:
- CAGR of 12% in patient population
- Price stabilization with slight discounts
Price Projections
| Year |
Projected Monthly Price (USD) |
Commentary |
| 2023 |
$15,000 |
Current market price |
| 2024 |
$14,500 |
Slight discount increase to expand volume |
| 2025 |
$14,000 |
Price stabilization, volume growth expected |
Realization of these prices depends on payer negotiations and competitive dynamics, with price erosion expected in mature markets.
Regulatory and Policy Impact
- Continued label expansion could increase indications, boosting revenue.
- Price controls and biosimilar competition could pressure margins after 2025.
- Payer restrictions may limit usage, affecting the overall market size.
Key Takeaways
- NDC 71288-0451 (Tucatinib) has a niche but growing market within HER2-positive breast cancer.
- Current annual treatment costs approximate $168,000 to $192,000.
- Market expansion hinges on label expansion, competition, and payer reimbursement policies.
- Future price stability relies on volume growth and market penetration efforts.
FAQs
Q1: What factors influence tucatinib’s market penetration?
Market penetration is driven by clinical efficacy, payer acceptance, treatment guidelines, and the availability of comparable drugs.
Q2: How does tucatinib compare in price to other HER2 inhibitors?
Tucatinib's monthly price is similar to neratinib but higher than trastuzumab biosimilars. Its cost reflects its targeted niche.
Q3: What is the outlook for tucatinib beyond breast cancer?
Potential expansion into other HER2-positive cancers, such as gastric or colorectal, could improve market size, pending clinical trial outcomes.
Q4: How might biosimilars impact the market?
While biosimilars mainly affect antibody therapies like trastuzumab, small-molecule TKIs like tucatinib may face limited biosimilar competition due to patent protections.
Q5: Are there any recent regulatory updates?
FDA approved tucatinib in 2020; no substantial new regulatory changes announced since then.
Sources:
[1] FDA. (2020). Drug approval for tucatinib.
[2] IQVIA. (2022). Oncology drug sales report.
[3] GoodRx. (2023). HER2-targeted therapies pricing.
[4] MarketWatch. (2023). Oncology market forecasts.
[5] American Cancer Society. (2022). Breast cancer statistics.
