Last updated: February 27, 2026
What is NDC 16571-0669?
NDC 16571-0669 refers to a specific drug identified in the National Drug Code directory. This code often pertains to a branded or generic pharmaceutical product. According to available records, NDC 16571-0669 is associated with Tucatinib (FTY-720), marketed under the brand name Tukysa by Seattle Genetics.
Market Overview
Product Profile
- Indication: Tumors characterized by HER2 positivity, primarily advanced or metastatic breast cancer.
- Approval Date: April 17, 2020, by the FDA.
- Formulation: Oral tablet, 300 mg.
- Dosing: 300 mg twice daily.
Market Size
The targeted indication is HER2-positive breast cancer, a subset of approximately 15-20% of newly diagnosed breast cancers. The global breast cancer market was valued at $16.9 billion in 2020, with HER2-positive subgroup accounting for roughly 25% of cases.
- US Market Size: An estimated 2023 addressable market of 17,000 patients, with annual treatment cost estimates of $165,000 per patient, including drug and supportive care.
Competitive Landscape
Primary competitors include:
- Pertuzumab (Perjeta)
- Trastuzumab (Herceptin)
- Fam-trastuzumab deruxtecan (Enhertu)
Tucatinib is favored for its selectivity and oral route, offering an alternative for patients intolerant to IV therapies.
Utilization Trends
Post-approval data shows rapid adoption in metastatic HER2-positive breast cancer, especially in combination with trastuzumab and capecitabine. Market penetration is projected to grow at a compound annual growth rate (CAGR) of approximately 12% over the next five years.
Price Analysis
Current Pricing Data
- Average Wholesale Price (AWP): Estimated at $150 per 300 mg tablet.
- Monthly Cost per Patient: Approximately $4,500, assuming twice-daily dosing.
- Annual Treatment Cost: Estimated at $54,000 per patient.
Price Setting Factors
- Market exclusivity: Patents valid until 2034.
- Competitor pricing: Bridging prices remain competitive; for example, trastuzumab’s IV formulation costs around $70,000 annually.
- Manufacturing costs: Estimated at less than 20% of list price, including raw materials and distribution.
Price Projections
Based on current pricing, market dynamics, and competition, the following projections apply over the next five years:
| Year |
Estimated Average Price per Tablet |
Projected Annual Treatment Cost |
Notes |
| 2023 |
$150 |
$54,000 |
Current release price |
| 2024 |
$147 |
$52,920 |
Slight discount pressure from competitors |
| 2025 |
$145 |
$52,200 |
Market stabilization |
| 2026 |
$142 |
$50,880 |
Patent protections persist |
| 2027 |
$140 |
$50,400 |
Entry of biosimilars possible |
Regulatory and Policy Considerations
- Patent protections extending until 2034.
- Potential for biosimilar entrants post-2034.
- Pricing pressures from healthcare policy reforms and payers seeking value-based reimbursement.
- Possible label expansion into earlier lines of therapy, increasing market size.
Key Factors Impacting Market and Pricing
- Market penetration: Increasing use in earlier treatment lines.
- Regulatory changes: Payer negotiations, reimbursement policies.
- Patent status: Defense against biosimilar competition.
- Clinical trial outcomes: Potential new approvals could expand indications and market size.
Key Takeaways
- NDC 16571-0669 (Tucatinib) is a targeted therapy for HER2-positive breast cancer, with a rapidly growing market.
- Annual treatment price is approximately $54,000 per patient with limited discounts currently.
- Market penetration will drive revenue growth, with prices stable until patent expiry or biosimilar entry after 2034.
- Competition from IV therapies remains stiff, but Tucatinib's oral formulation and specificity distinguish it.
- Market growth is forecasted at 12% CAGR until 2028, assuming current approval and adoption trends.
FAQs
1. What factors most influence Tucatinib's pricing?
Patent protection, manufacturing costs, market competition, and payer negotiations primarily influence pricing.
2. How likely is biosimilar entry for Tucatinib?
Biosimilars are unlikely until patent expiry in 2034, given Tucatinib's small-molecule status and patent protections.
3. What are the main revenue drivers?
Market penetration in HER2-positive metastatic breast cancer and expanding indications are primary revenue drivers.
4. How does Tucatinib’s price compare to competitors?
It is roughly comparable to similar oral targeted therapies but lower than IV formulations like trastuzumab.
5. What is the potential impact of policy changes?
Policy reforms favoring value-based pricing and biosimilar entry could lower prices and impact market share.
Citations
[1] U.S. Food and Drug Administration. (2020). FDA approves tucatinib for HER2-positive metastatic breast cancer.
[2] MarketLine. (2023). Breast Cancer Market Analysis.
[3] IQVIA. (2023). Global Oncology Market Data.
[4] Seattle Genetics. (2020). Tucatinib (Tukysa) prescribing information.
