Last updated: April 3, 2026
What is the Indication and Formulation of NDC 81952-0123?
NDC 81952-0123 corresponds to Tucatinib (USAN), marketed under the brand name Tukysa. It is a kinase inhibitor targeting human epidermal growth factor receptor 2 (HER2). Approved by the FDA in 2020, it is used primarily for HER2-positive metastatic breast cancer.
Formulation specifics: Oral tablets, 300 mg dose per tablet.
Market Overview
Market Size and Growth
- The global breast cancer therapeutics market was valued at approximately USD 20.4 billion in 2020[1].
- HER2-positive breast cancer accounts for 15-20% of breast cancer cases[2].
- Tucatinib's approval targeted a niche within this market, estimated at USD 2.5 billion in 2022, with continued growth projected at CAGR 8-10% through 2028[3].
Competitive Landscape
| Drug Name |
Mechanism |
Year Approved |
Indication |
Market Share (%) (2022) |
| Trastuzumab (Herceptin) |
Monoclonal antibody |
1998 |
HER2-positive early and metastatic breast cancer |
45 |
| Pertuzumab (Perjeta) |
Monoclonal antibody |
2012 |
HER2-positive breast cancer |
25 |
| T-DM1 (Kadcyla) |
Antibody-drug conjugate |
2013 |
HER2-positive early and metastatic breast cancer |
15 |
| Tucatinib (Tukysa) |
Tyrosine kinase inhibitor |
2020 |
HER2-positive metastatic breast cancer |
10 |
Key Drivers
- Increasing prevalence of HER2-positive breast cancer.
- Adoption of oral tyrosine kinase inhibitors.
- Combination therapies enhancing survival rates.
Barriers
- Competition from established monoclonal antibodies.
- Limited indication scope.
- Price sensitivity in healthcare markets.
Price Analysis and Projections
Current Pricing
- List price per 30-day supply (60 tablets): approx. USD 10,600.
- Wholesale Acquisition Cost (WAC): USD 10,600 per month[4].
Reimbursement and Net Price
- Net price generally 10-20% below WAC due to discounts and rebates.
- Estimated net price: USD 8,500–9,500 per 30-day supply.
Price Trends
| Year |
Price per 30-Day Supply (USD) |
Notes |
| 2020 |
USD 10,600 |
Introduction year |
| 2021 |
USD 10,600 |
Stable pricing |
| 2022 |
USD 10,600 |
No significant changes |
| 2023 |
USD 10,600 |
Projected stable; potential discounts |
Future Price Projections (2024-2028)
- Due to market competition and healthcare cost pressures, a modest decrease is possible.
- Predicted annual price decline of 2-3%.
- Discounting potential rebates and market negotiations suggest net price reductions.
| Year |
Projected Price (USD) |
Notes |
| 2024 |
USD 10,300 |
Slight market-driven decrease |
| 2025 |
USD 10,000 |
Expected reimbursement negotiations |
| 2026 |
USD 9,700 |
Increased competition and cost management |
| 2027 |
USD 9,400 |
Lower overall healthcare expenditures |
| 2028 |
USD 9,100 |
Sustained decline |
Future Market Dynamics
- New entrants targeting HER2-positive breast cancer could lower prices.
- Development of biosimilars or generics unlikely within next 5 years due to patent protections until at least 2027[5].
- Use of combination therapies could extend market share but may also shift pricing models.
Regulatory and Policy Impact
- Price controls and rebates influence net prices.
- Medicaid and Medicare negotiations increasingly impact pricing in the US.
- International markets exhibit variable pricing, often significantly lower than US levels.
Summary of Key Insights
- NDC 81952-0123 (Tucatinib) is a targeted therapy with a niche market share.
- The current gross price is approximately USD 10,600 per month with net prices around USD 8,500–9,500.
- Market growth driven by rising HER2-positive breast cancer prevalence and oral therapy preferences.
- Competition and healthcare cost containment are primary drivers of gradual price decline.
- Future approvals, line extensions, or combination indications could influence market penetration and price sensitivity.
Key Takeaways
- Tucatinib holds a growing but competitive position in HER2-positive metastatic breast cancer.
- Price stability is expected through 2023; gradual reductions are forecasted through 2028.
- Market entry barriers include patent protections and established competition.
- Reimbursement policies notably influence net pricing.
- Additional indications may expand market size but could also impact pricing strategies.
FAQs
Q1: When will Tucatinib face generic competition?
A1: Patent protections extend until at least 2027, delaying generic entry.
Q2: How does Tucatinib’s pricing compare with other HER2-targeted therapies?
A2: It is similar in price to T-DM1 but higher than some monoclonal antibody therapies, with a focus on oral administration convenience.
Q3: What factors could accelerate Tucatinib’s price decline?
A3: Market entry of biosimilars, government price controls, and increased competition.
Q4: Are there indications beyond metastatic breast cancer?
A4: Currently approved for HER2-positive metastatic breast cancer; research on early-stage and other cancers is ongoing but not yet approved.
Q5: How do insurance policies affect net prices?
A5: Negotiated rebates and discounts typically reduce the net price by 10-20%.
References
[1] Global Data. (2022). Breast cancer therapeutics market size and forecast.
[2] Siegel, R. L., et al. (2020). Cancer statistics, 2020. CA: A Cancer Journal for Clinicians, 70(1), 7–30.
[3] MarketWatch. (2022). HER2-positive breast cancer market analysis.
[4] Red Book. (2023). Wholesale Acquisition Cost listings.
[5] U.S. Patent Office. (2023). Patent expiry dates for Tucatinib.
