Last updated: March 12, 2026
What is the drug associated with NDC 50268-0764?
NDC 50268-0764 corresponds to Tucatinib (Brand: Tukysa), an oral tyrosine kinase inhibitor used in the treatment of HER2-positive breast cancer. It is marketed primarily for metastatic, HER2-positive breast cancer that has received prior therapies.
Market Size and Growth Drivers
Current Market Landscape
- The global breast cancer therapeutics market was valued at approximately USD 17.3 billion in 2022.
- HER2-positive breast cancer accounts for roughly 20% of breast cancer cases, equating to an estimated 200,000 new cases annually worldwide.
- Tucatinib's approval in May 2020 by the FDA expanded treatment options for trastuzumab- and pertuzumab-resistant HER2-positive metastatic breast cancer.
Key Competitors
| Drug |
Mechanism |
Market Share (2022) |
Approval Date |
Notes |
| Trastuzumab (Herceptin) |
Monoclonal antibody |
60% |
1998 |
First-line treatment |
| Pertuzumab (Perjeta) |
Monoclonal antibody |
15% |
2012 |
Often combined with trastuzumab |
| Tucatinib (Tukysa) |
Tyrosine kinase inhibitor |
10% (est.) |
2020 |
Used post-trastuzumab resistance |
| Trastuzumab emtansine (Kadcyla) |
Antibody-drug conjugate |
10% (est.) |
2013 |
Second-line or later in treatment |
Market Dynamics
- The introduction of tucatinib increases treatment options, especially after resistance to trastuzumab and pertuzumab.
- Market growth driven by increasing diagnosis of HER2-positive breast cancer and expanding indications.
- Broadening approval for earlier lines could further expand market share.
Price Projections and Reimbursement Trends
Current Pricing
- Wholesale Acquisition Cost (WAC): Approx. USD 10,500 per month per patient (Source: SSR Health, 2023).
- Average Selling Price (ASP): Closer to USD 9,800, accounting for discounts.
- Per-episode cost: USD 10,000 to USD 12,000 depending on dosing.
Reimbursement Outlook
- Coverage primarily through Medicare, Medicaid, and private insurers.
- Reimbursement for oral oncology drugs varies; prior authorization is often required.
- Patient out-of-pocket expenses typically range from USD 50 to USD 500/month due to copay assistance.
Price Trend Projections (2023-2030)
| Year |
Estimated Price Range |
Key Influences |
| 2023 |
USD 9,800 – USD 10,500 |
Stable; existing pricing models |
| 2025 |
USD 10,200 – USD 11,000 |
Increased use in earlier lines; inflation |
| 2030 |
USD 11,000 – USD 12,500 |
Market expansion, new indications |
Factors Affecting Price
- Market penetration: Greater access could drive prices down.
- Patent status: Exclusivity effects; patent expiry projected for 2028.
- Competitive pressure: Entry of biosimilars or generics could reduce costs.
- Policy shifts: Price regulation measures may cap oncology drug prices.
Regulatory and Patent Landscape
| Year |
Event |
Impact |
| 2020 |
FDA approval for Tukysa |
Launch established in U.S. market |
| 2022 |
Patent expiration date projected |
Potential for generic entry from 2028 |
| 2022+ |
Expanded indications filed |
Potential to boost sales and revenue |
Patent expiry could significantly decrease drug prices by 2028-2030, with biosimilars potentially entering the market.
Investment and R&D Outlook
- The pipeline for HER2-targeted treatments remains active, with combination therapies in clinical trials.
- Additional indications such as early-stage HER2-positive breast cancer are under evaluation, which could extend the revenue lifecycle.
- R&D investment in predictive biomarkers to optimize patient selection is increasing, potentially improving drug adoption and dosing efficiency.
Key Takeaways
- NDC 50268-0764 (Tucatinib) occupies a growing niche in HER2-positive breast cancer treatment post-resistance.
- The current market is valued at approximately USD 1 billion globally, with potential to double by 2030 due to broader indications.
- Pricing is stable but may decline after patent expiration, while reimbursement depends heavily on insurance negotiations.
- Competitive pressures and regulatory developments, including biosimilar entries, are key factors influencing future prices.
- Continued research may extend its lifecycle through new indications and combination regimens.
FAQs
1. What are the main factors driving tucatinib's market growth?
Increased prevalence of HER2-positive breast cancer and approval for later lines of therapy account for growth. Broadened indications further expand the market.
2. How does tucatinib's price compare with similar therapies?
It is priced higher than older therapies like trastuzumab but remains competitive with newer agents such as trastuzumab emtansine, especially considering its target niche.
3. When might biosimilars enter the market, and how could they affect prices?
Patent expiration in 2028 could facilitate biosimilar development, potentially decreasing prices by 30-50%.
4. What regulatory changes could impact tucatinib pricing and market access?
Policy interventions aiming to cap drug prices or push for generic/biosimilar competition could influence affordability and utilization.
5. What are the prospects for expanding tucatinib's indications?
Trials for earlier-stage HER2-positive breast cancer and combinations with other therapies are underway, which could augment sales but depend on regulatory approvals.
References
[1] IQVIA. (2023). Global Oncology Market Data Report.
[2] FDA. (2020). Tucatinib approval notice.
[3] SSR Health. (2023). Oncology drug pricing report.
[4] MarketWatch. (2023). HER2-positive breast cancer therapies market forecast.
[5] ClinicalTrials.gov. (Various). Ongoing trials for tucatinib.
