Last updated: March 1, 2026
What is NDC 50268-0779?
NDC 50268-0779 refers to a specific drug product identified by the National Drug Code. This code corresponds to Tucatinib (brand name: Tukysa), a targeted therapy approved for treating HER2-positive breast cancer, including metastatic cases.
Market Overview
Indications and Competitive Landscape
- Primary indications: Treatment of adult patients with advanced HER2-positive breast cancer, especially after previous therapies.
- Market size: The global HR2-positive breast cancer market was valued at approximately USD 2.5 billion in 2022, projected to grow at a CAGR of 8% through 2030.
- Key competitors: Trastuzumab deruxtecan (Enhertu), Pertuzumab (Perjeta), and other HER2-targeted therapies.
- Regulatory status: Approved by the FDA in April 2021 under accelerated approval, requiring confirmatory trials.
Market Drivers
- Increased prevalence of HER2-positive breast cancer.
- Growing adoption of targeted therapies.
- Unmet needs in metastatic and refractory cases.
Market Challenges
- Pricing and reimbursement complexity.
- Competition with established therapies.
- Need for ongoing clinical trial data supporting long-term efficacy.
Price Structure and Projections
Current Pricing
- List price (as of Q1 2023): Approximately USD 11,000 per month per patient (based on manufacturer data and retail pricing estimates).
- Reimbursement: Pricing varies based on geographic region, insurance coverage, and negotiated discounts, with payers typically applying substantial rebates.
Price Trends
- Initial launch price aligned with similar niche targeted therapies.
- Expected to see stabilization in pricing, contingent upon clinical outcomes and regulatory milestones.
- Price reductions may occur with increased competition or generic entry, although no generics are forecasted in the near term due to patent protections.
Projected Prices (2024–2028)
| Year |
Estimated Average Monthly Price |
Notes |
| 2024 |
USD 10,500 – USD 11,000 |
Stability expected unless new competitors emerge. |
| 2025 |
USD 10,000 – USD 10,500 |
Slight reduction due to market maturation and negotiations |
| 2026 |
USD 9,500 – USD 10,000 |
Market saturation effects influence pricing. |
| 2027 |
USD 9,000 – USD 9,500 |
Continued price moderation, potential for discounts. |
| 2028 |
USD 8,500 – USD 9,000 |
Market stabilization with potential entry of biosimilars |
Market Penetration and Adoption
- Initial uptake: Limited to specialized oncology centers and top-tier hospitals due to the drug’s specialized indication.
- Growth trajectory: Expected to reach 20–30% treatment penetration in eligible patients by 2028.
- Reimbursement impact: Coverage policies influence market access; high-cost drugs face scrutiny but benefit from label expansion and positive clinical data.
Regulatory and Policy Influences
- FDA approval status: Conditional approval impacts early access and pricing.
- Reimbursement policies: Capped by healthcare payer negotiations; policy shifts toward value-based pricing can influence future prices.
- Patent status: Patent protection in place until at least 2030, limiting generic competition.
Key Takeaways
- NDC 50268-0779 (Tucatinib) is a targeted therapy in a growing breast cancer segment with a high unmet need.
- Current list prices are around USD 11,000/month with reimbursement and discounts heavily influencing the actual price to payers.
- Market revenues are expected to grow, albeit with price stabilizations driven by competition and market dynamics.
- Price projections indicate a gradual decrease over five years, assuming market saturation and potential biosimilar development.
FAQs
1. How do regulatory approvals impact pricing?
Accelerated or conditional approvals allow earlier market entry but often lead to higher initial prices due to limited long-term data.
2. What factors could lead to price reductions?
Introduction of biosimilars, increased competition, patent expirations, and policy reforms geared toward cost containment.
3. Who are the primary payers for this drug?
Commercial insurance providers, Medicare, Medicaid, and specialized healthcare programs.
4. What is the impact of clinical trial outcomes on pricing?
Positive long-term efficacy data can support value-based pricing, potentially sustaining or increasing prices.
5. Are biosimilars expected for Tucatinib?
No biosimilars are anticipated before patent expiration in 2030, giving manufacturers pricing power in the near term.
Sources
[1] IQVIA. (2022). Oncology Market Trends.
[2] FDA. (2021). Tucatinib (Tukysa) Approval Documentation.
[3] MarketWatch. (2023). HER2-Positive Breast Cancer Therapeutics Market Report.
[4] Statista. (2023). Targeted Cancer Therapy Pricing Data.
[5] EvaluatePharma. (2023). Oncology Drug Forecasts.
