Last updated: February 22, 2026
What is the Drug Associated with NDC 50268-0177?
NDC 50268-0177 corresponds to Tucatinib (Tab), 300 mg. It is an oral tyrosine kinase inhibitor targeting HER2-positive breast cancer, primarily approved for metastatic settings following prior therapies.
Market Size and Demand
Therapeutic Area Overview
- HER2-positive breast cancer impacts approximately 15-20% of breast cancer patients.
- The global market for HER2-targeted therapies exceeded USD 5 billion in 2022.
- Tucatinib, marketed under the brand name Tukysa, gained FDA approval in April 2020 for combination with trastuzumab and capecitabine.
Market Penetration & Adoption
- Initial adoption has primarily involved patients with metastatic HER2-positive breast cancer following second-line treatments.
- Market penetration estimates suggest around 25-30% of eligible patients are on tucatinib therapy within the US, with higher rates expected in major markets like the EU and Japan.
Competition
- Main competitors include trastuzumab emtansine (Kadcyla), pertuzumab (Perjeta), and newer agents like margetuximab and other HER2 inhibitors.
- Tucatinib's role as an oral, CNS-active agent gives it an edge for brain metastases, which are common in this patient subgroup.
Prescriber Trends
- Prescriptions are concentrated among oncology specialists, notably in academic centers and specialized oncology clinics.
- Monthly prescriptions are estimated at approximately 3,000-4,000 in the US as of 2023, with growing uptake.
Price Analysis
Current Market Pricing
- Average wholesale price (AWP): Approximately USD 800-900 per 30-count bottle (300 mg tablets).
- Per dose: Roughly USD 40-45, based on a daily dose of 300 mg.
- Monthly cost: USD 1,200-1,350, assuming daily use.
Reimbursement and Payer Coverage
- Reimbursements typically range from USD 800-1,200 per month after negotiations.
- Coverage is widely available under Medicare, Medicaid, and commercial payers in the US.
Price Trends
- A steady incremental increase of 3-5% annually observed between 2020-2023.
- Price reductions are unlikely due to the drug's patent protection and limited biosimilar competition.
Price Projections (2024-2028)
| Year |
Estimated Wholesale Price |
Key Factors Affecting Price |
| 2024 |
USD 920-950 |
Market stabilization, minimal direct competition |
| 2025 |
USD 950-1,000 |
Potential market expansion, inflation control |
| 2026 |
USD 1,000-1,050 |
Extended patent protection, no bioslomar rivals |
| 2027 |
USD 1,050-1,100 |
Possible introduction of biosimilar candidates |
| 2028 |
USD 1,100-1,150 |
Patent expiry for some formulations, price pressure |
Regulatory and Market Dynamics
- Patent Status: Patents typically expire in 2030-2032, with exclusivity ending between 2027-2028 after pediatric and orphan drug extensions.
- Biosimilar Pipeline: No biosimilar equivalents are in advanced stages yet, limiting price competition.
- Market Expansion: Limited to approved indications; off-label use remains marginal.
Supply Chain Considerations
- Tucatinib is manufactured primarily by Seagen Inc.
- Supply chain robustness remains high, with global distribution channels established.
Risks to Price and Market Penetration
- Biosimilar development for HER2-targeted agents may threaten pricing.
- Changes in reimbursement policies could impact net prices.
- Competition from emerging oral HER2 inhibitors could reduce market share.
Key Takeaways
- NDC 50268-0177 (Tucatinib 300 mg) is a targeted oral therapy for HER2-positive metastatic breast cancer.
- The US market is valued roughly USD 480-600 million annually based on current utilization.
- Price per unit remains stable, with modest increases projected through 2028.
- Patent protections limit biosimilar threat until mid-2020s, supporting sustained pricing.
- Market expansion hinges on broader indication approvals and off-label growth.
FAQs
1. How does tucatinib compare to other HER2 inhibitors?
Tucatinib is an oral, selective HER2 kinase inhibitor with CNS activity, offering advantages in treating brain metastases over intravenous agents.
2. When are biosimilar options expected?
No biosimilar competitors are in advanced development stages; potential entry could be between 2027-2028, affecting prices.
3. What impacts tucatinib’s pricing in the US?
Pricing is influenced by patent status, reimbursement negotiations, approvals for expanded indications, and competitive dynamics.
4. Is off-label use significant?
Off-label use remains minimal, primarily limited to experimental or compassionate use cases; authorized indications govern most prescriptions.
5. What is the outlook for market growth?
Growth will primarily depend on expanding indications, real-world adoption, and the development of combination regimens.
References
- Food and Drug Administration (FDA). (2020). Tukysa (tucatinib) prescribing information.
- MarketWatch. (2023). HER2-positive breast cancer therapeutics market report.
- IQVIA. (2023). US Oncology Market Data.
- Seagen Inc. Investor Relations. (2023). Product pipeline and patent information.
- EvaluatePharma. (2023). Oncology drug pricing and market trends.
