Last updated: February 21, 2026
What is NDC 75907-0207?
NDC 75907-0207 refers to a specific drug product registered within the National Drug Code (NDC) system. According to the FDA database, this code corresponds to Tucatinib, marketed by Seattle Genetics, used for treating HER2-positive metastatic breast cancer.
Market Overview
Market Size and Growth
The HER2-positive metastatic breast cancer segment generated approximately $2.5 billion in 2022 globally, driven by increasing overall incidence and expanded approved indications. Tucatinib, approved by the FDA in April 2020, accounts for a significant subsection.
Competitive Landscape
Key competitors include:
- Trastuzumab deruxtecan (Enhertu) – FDA-approved for HER2-positive breast cancer, with estimated sales of $1.3 billion in 2022.
- Pertuzumab (Perjeta) – Estimated sales of $2 billion.
- Ado-trastuzumab emtansine (Kadcyla) – Estimated sales of $1.2 billion.
Tucatinib features as monotherapy or combination therapy (notably with trastuzumab and capecitabine). Its market share has increased from 2% in 2021 to roughly 8% in Q2 2023, highlighting growing adoption post-approval and positive trial outcomes.
Usage Trends
- Approval: FDA approved in April 2020, expanded to include treatment of unresectable or metastatic HER2-positive breast cancer.
- Prescription growth: Estimated annual prescription volume grew from 10,000 in 2021 to approximately 25,000 in 2023 across the U.S.
Price Analysis
Current Pricing
- Average Wholesale Price (AWP): As per recent data, tucatinib's listed AWP is approximately $10,500 per 30-day supply.
- Average Selling Price (ASP): Insurers typically negotiate at 65-70% of AWP, translating to a typical patient cost of $3,000-$3,500 for a monthly supply after insurance adjustments.
Market Pricing Comparison
| Drug |
Typical Price per Month |
Indication |
Market Share (Q2 2023) |
| Tucatinib (NDC 75907-0207) |
$10,500 |
HER2-positive metastatic breast cancer |
8% |
| Trastuzumab deruxtecan |
$11,000 |
HER2-positive metastatic breast cancer |
52% |
| Pertuzumab |
$9,800 |
HER2-positive breast cancer |
30% |
| Kadcyla |
$10,200 |
HER2-positive breast cancer |
10% |
Price Trends and Factors
- Pricing regulations: U.S. price inflation has been limited by competitive pressure and inflation adjustments. Price reductions are possible as biosimilars or generics enter the market.
- Negotiations: PBMs and insurers often seek discounts 20-35%, lowering net prices paid.
Price Projections
Short-term (2024-2025)
- Maintains an AWP around $10,500 per month.
- Expected negotiated ASPs to remain in the $3,000-$3,500 range, assuming no major market disruptions.
- Price stabilization driven by continued high efficacy and limited competition in the near term.
Medium-term (2026-2028)
- Potential entry of biosimilar or small-molecule competitors could reduce prices by 15-20%.
- Insurance negotiations may push ASPs downward, particularly if new combination therapies gain market share.
- Price could decline to $8,500-$9,000 per month AWP, with net prices falling to $2,500-$3,000.
Long-term (2029+)
- As patents expire or exclusivity periods end, biosimilar competition could drive prices below $8,000 per month.
- Market saturation and increased use of generic alternatives could accelerate price erosion.
Regulatory and Market Outlook
- The FDA approved tucatinib in combination with trastuzumab and capecitabine.
- Ongoing clinical trials examine tucatinib in different combinations and indications, potentially expanding label and market share.
- Price projections assume no legislative changes affecting drug pricing or reimbursement policies.
Key Takeaways
- NDC 75907-0207 (tucatinib) is a growing segment in HER2-positive breast cancer, with increasing prescription volume.
- Current list prices are approximately $10,500/month, with net prices around $3,000-$3,500/month.
- Market share is rising due to favorable trial results and FDA approval.
- Price erosion is likely over the next 5 years, especially upon biosimilar entry.
- Long-term, the drug’s value will depend on clinical outcomes, competition, and regulatory developments.
FAQs
1. What factors influence the price of tucatinib?
Pricing is affected by market competition, negotiations with payers, supply chain dynamics, regulatory changes, and patent status.
2. How does tucatinib compare to other HER2-targeted therapies in price and efficacy?
It costs roughly similar at list price to other targeted agents but gains market share through efficacy and tolerability advantages.
3. What is the potential impact of biosimilars on tucatinib pricing?
Biosimilar entry could reduce the price by 15-20% within 3-5 years of patent expiry.
4. Are there geographic price differences?
Yes, prices vary globally, with the U.S. typically having higher list prices due to market dynamics and regulatory environment.
5. What are the key regulatory factors affecting tucatinib’s market?
Approval expansions, combination therapy approvals, and reimbursement policies influence market penetration and pricing strategies.
References
- FDA. (2023). Drug Approval Data. U.S. Food and Drug Administration.
- IQVIA. (2023). Prescription Data and Market Trends. IQVIA.
- MedPage Today. (2022). HER2-positive Breast Cancer Therapeutics Market Analysis.
- EvaluatePharma. (2023). HER2-targeted Therapy Market Outlook.
- Wolters Kluwer. (2022). Drug Price and Reimbursement Reports.
