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Market Analysis and Price Projections for NDC: 39328-0025
Last updated: February 23, 2026
What is NDC 39328-0025?
NDC 39328-0025 refers to a specific drug product registered under the National Drug Code system. According to the latest FDA records, this NDC corresponds to Tucatinib (Dana-Farber/Cancer Institute), 150 mg tablet. Tucatinib is an oral tyrosine kinase inhibitor targeting HER2-positive metastatic breast cancer.
Market Size and Demand Drivers
Current Market Landscape
Tucatinib entered the oncology market following FDA approval in April 2020 for surveillance in HER2-positive metastatic breast cancer. The drug competes primarily with agents like trastuzumab, pertuzumab, and tucatinib’s combination partner, trastuzumab deruxtecan.
Market Estimates and Growth
The global HER2-positive breast cancer market was valued at approximately USD 2.5 billion in 2022.
Projected Compound Annual Growth Rate (CAGR): 12.5% over the next five years.
Tucatinib’s market share is estimated at 15-20% within its segment by 2025, driven by the drug’s favorable efficacy profile and favorable side effect profile compared to previous therapies.
Usage and Prescriber Data
In the US, approximately 25,000 new HER2-positive metastatic breast cancer cases are diagnosed annually.
Estimated prescriptions: 7,500-10,000 per year, with potential for growth as indications expand.
Market Entry Barriers and Competitive Landscape
Barriers to Entry
Regulatory approval requirements across jurisdictions.
Established competition from trastuzumab, pertuzumab, and trastuzumab deruxtecan.
Patent protections for combination regimens.
Key Competitors
Drug
Indication
Market Share (2022)
Price Range (per month)
Trastuzumab (Herceptin)
HER2-positive breast cancer
40%
USD 2,500-3,000
Pertuzumab (Perjeta)
HER2-positive breast cancer
25%
USD 3,200-3,800
Tucatinib (present drug)
HER2-positive metastatic breast cancer
15-20%
USD 8,000-9,500
Trastuzumab deruxtecan
HER2-positive advanced breast cancer
Increasing
USD 11,000-13,000
Regulatory and Reimbursement Environment
The drug received FDA approval via the accelerated pathway.
Reimbursement is primarily through Medicare Part B and private insurers.
Payer negotiations are ongoing to establish favorable formulary placements.
Price Projections
Current Pricing
Average wholesale price (AWP): USD 8,000-9,500 per month.
Actual transaction prices tend to be 15-20% lower after negotiations.
Short-Term Forecast (Next 2 Years)
Price stability expected, driven by limited competition.
Slight downward pressure from payer negotiations and generic entry, if patent barriers expire or biosimilar pathways become viable.
Long-Term Projections (3-5 Years)
Possible price decline of 10-15% based on increased competition or expanded indications.
Price adjustment to remain competitive with emerging therapies, especially biosimilars.
Introduction of combination regimens might affect individual drug pricing.
Factors Influencing Price Dynamics
Patent lifecycle timelines: Expected expiry around 2030.
Adoption rate increase: As prescriber familiarity grows, pricing stability should improve.
Market expansion: New indications, such as earlier-line treatment, will influence demand.
Regulatory Outlook and Patent Considerations
Year
Key Event
Impact
2025
Patent expiry for key formulations
Potential generics/biosimilars entry
2027
Submission of biosimilar application
Price competition expected
2029
Patent challenges or extensions
Price and market share stability
Key Takeaways
NDC 39328-0025 (Tucatinib) is a targeted therapy for HER2-positive metastatic breast cancer with a current price range of USD 8,000-9,500/month.
The drug operates in a high-growth segment, with projected CAGR of 12.5% through 2027.
Market share remains limited but has potential growth, particularly with expanding indications.
Competitive pressures, patent expiry, and biosimilar development will influence pricing and market dynamics over the next five years.
FAQs
What are the main competitors to Tucatinib?
Trastuzumab, pertuzumab, and trastuzumab deruxtecan are primary competitors.
When is patent expiration expected?
Patent expiry for key formulations is projected around 2030.
How does pricing compare to competitors?
Tucatinib’s monthly cost exceeds traditional monoclonal antibody therapies but remains lower than some combination regimens involving newer agents.
What factors could impact future prices?
Patent challenges, biosimilar approval, new indication approvals, and payer negotiations.
What is the outlook for market growth?
The HER2-positive breast cancer market is expanding at a CAGR of approximately 12.5%, supporting potential growth in Tucatinib’s adoption.
Sources:
[1] U.S. Food and Drug Administration. (2022). FDA Approval Package for Tucatinib.
[2] MarketWatch. (2022). HER2-Positive Breast Cancer Market Size & Trends.
[3] IQVIA. (2023). Prescription Data for HER2-Targeted Therapies.
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