Last updated: February 27, 2026
What Is NDC 70677-1184?
NDC 70677-1184 corresponds to Tucatinib oral medication marketed by Seattle Genetics. It targets HER2-positive breast cancer, primarily in metastatic settings.
Current Market Position
Indication and Approval Status
- FDA approval date: April 2020.
- Indicated for: HER2-positive metastatic breast cancer, including brain metastases.
- Status: Approved for combination with trastuzumab and capecitabine.
Market Size
- HER2-positive breast cancer accounts for approximately 15-20% of breast cancer cases.
- Estimated global HER2-positive breast cancer market value (2022): $4.8 billion.
- Tucatinib's specific segment: Focuses on advanced/metastatic cases, representing approximately 30% of HER2-positive submarket; estimated at $1.4 billion.
Competitive Landscape
- Main competitors:
- Trastuzumab deruxtecan (Daiichi Sankyo)
- Pertuzumab (Roche)
- Lapatinib (Novartis)
- Ado-trastuzumab emtansine (T-DM1) (Roche)
- Tucatinib's differentiation lies in its efficacy in patients with brain metastases.
Market Dynamics
Patent and Exclusivity
- Patent expiry anticipated: 2028.
- Orphan drug status received in certain regions; may influence market exclusivity.
Adoption Factors
- Physician familiarity with HER2-targeted therapies.
- Real-world evidence supporting the efficacy in brain metastasis.
- Reimbursement policies for combination therapies.
Pricing History and Trends
- Launch price (2020): Approx. $10,500 per month.
- Price adjustments:
- Slight reductions following negotiations and insurance coverage improvements.
- Historical reasons include competition and reimbursement pressures.
Pricing Benchmarks
| Drug |
Typical Monthly Price |
Market Segment |
| Tucatinib (NDC 70677-1184) |
$10,500 |
HER2-positive metastatic breast cancer |
| Trastuzumab deruxtecan |
$16,000 |
Advanced HER2-positive breast cancer |
| Pertuzumab |
$8,500 |
First-line HER2-positive breast cancer |
| Lapatinib |
$7,200 |
Metastatic HER2-positive breast cancer |
Note: These are estimations based on list prices and typical negotiations.
Price Projections (2023-2028)
Factors Influencing Future Pricing
- Patent protection ending in 2028 creates potential for biosimilar entry.
- Competition intensity from emerging therapies.
- Evolving reimbursement policies and healthcare innovations.
- Updated clinical data demonstrating survival benefits or resistance.
Projection Scenarios
-
Optimistic (Limited Biosimilar Competition):
- Price remains stable at ~$10,000–$11,000 per month until patent expiry.
- Slight increases projected for inflation and value-based adjustments.
-
Moderate Competition Entry (~2027):
- Price drops by 15–25% in anticipation of biosimilar market entry.
- Stabilization at ~$8,000–$9,500 per month.
-
High Competition and Biosimilar Entry (>2028):
- Price declines to ~$5,000–$6,000 per month within 2 years post-patent expiry.
- Market share shifts significantly towards biosimilars.
Revenue Forecast
| Year |
Estimated Sales |
Price per Unit |
Volume (patients) |
Total Revenue |
| 2023 |
$200 million |
$10,500 |
1,600 |
$168 million |
| 2024 |
$220 million |
$10,000 |
1,700 |
$170 million |
| 2025 |
$250 million |
$9,000 |
2,000 |
$180 million |
| 2026 |
$280 million |
$8,500 |
2,200 |
$187 million |
| 2027 |
$300 million |
$8,500 |
2,200 |
$187 million |
| 2028 |
$250 million |
$6,000 |
2,200 |
$132 million |
(All figures are estimates based on market dynamics and historical pricing trends.)
Key Takeaways
- NDC 70677-1184 (tucatinib) has a specialized niche in HER2-positive metastatic breast cancer with brain metastasis.
- Its pricing was stable around $10,500/month since launch; future prices may decline post-2028 due to biosimilar competition.
- The market is expected to grow modestly until patent expiration, with a potential decline afterward.
- Competition from other targeted therapies, especially biosimilars, will influence prices and market share.
FAQs
Q1: When does the patent for tucatinib expire?
A1: Patent protection is expected to expire in 2028, opening the market for biosimilars or generics.
Q2: How does tucatinib compare in price to other HER2-targeted drugs?
A2: Tucatinib's launch price of approximately $10,500/month is lower than trastuzumab deruxtecan ($16,000/month) but higher than lapatinib ($7,200/month).
Q3: What factors could accelerate the decline in tucatinib prices?
A3: Biosimilar entry, increased competition, and healthcare policy adjustments favoring cost savings.
Q4: How does tucatinib’s efficacy in brain metastases impact its market?
A4: It provides a differentiation advantage, likely increasing adoption among oncologists managing metastatic HER2-positive patients with brain involvement.
Q5: Are there any upcoming clinical trials that could influence tucatinib’s market?
A5: Ongoing trials examining tucatinib in earlier line settings and combination regimens could expand its use, potentially impacting pricing and revenue.
References
[1] U.S. Food and Drug Administration. (2020). FDA approves tucatinib for HER2-positive breast cancer. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-tucatinib-her2-positive-breast-cancer
[2] Market data and pricing based on industry sources including GoodRx, NICE, and peer-reviewed reports (2022-2023).
[3] Industry analysis reports from IQVIA, GlobalData, 2022.
[4] Patent expiry and biosimilar entry projections from IQVIA and industry patent registries.
