Last updated: March 27, 2026
What is NDC 76204-0025?
NDC 76204-0025 refers to Tucatinib (brand: Tukysa), a tyrosine kinase inhibitor approved for treating HER2-positive metastatic breast cancer. The Food and Drug Administration (FDA) granted its approval in April 2020. The drug is marketed by Seattle Genetics.
Current Market Landscape
Market Size
The global metastatic HER2-positive breast cancer market was valued at approximately $1.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 8% through 2030. The increasing incidence of HER2-positive breast cancers, combined with the adoption of targeted therapies, drives this growth.
Key Competitors
| Drug Name |
Indication |
Approval Year |
Market Share (2022) |
Price (per 30-day supply) |
| Tucatinib (Tukysa) |
HER2-positive metastatic breast cancer |
2020 |
25% |
$12,000–$14,000 |
| Trastuzumab (Herceptin) |
HER2-positive breast cancer |
1998 |
40% |
$6,500–$8,000 |
| Pertuzumab (Perjeta) |
HER2-positive breast cancer |
2012 |
20% |
$10,000–$12,500 |
| Ado-trastuzumab emtansine (Kadcyla) |
HER2-positive breast cancer |
2013 |
10% |
$13,000–$15,000 |
Tucatinib's market penetration is growing via line of therapy, often used alongside trastuzumab and chemotherapy in advanced cases.
Sales Trends
Sales for Tucatinib are expected to reach $300 million in 2023, expanding to over $600 million by 2025. Sales confidence hinges on ongoing clinical trials, expanded indications, and competitive dynamics; key studies focus on early-line therapy.
Pricing Strategies
Current Pricing
Tucatinib's wholesale acquisition cost (WAC) across U.S. providers approximates $14,000 per 30-day supply, depending on dose adjustments. The pricing aligns with other targeted therapies but remains below trastuzumab's price point.
Factors Influencing Price
- R&D Expenses: Estimated at $1 billion including clinical trials and regulatory costs.
- Market Penetration: Price supports aggressive adoption in combination regimens.
- Reimbursement Policies: Managed care plans influence net price, with discounts and rebates reducing the actual transaction price.
Price Trends
Price stability is anticipated through 2025, barring new entrants or patent challenges. Post-2025, potential price erosion expected due to biosimilar developments and competition.
Regulatory and Market Access Dynamics
Patent and Exclusivity
Tucatinib's patent protection extends until 2030, with Hatch-Waxman exclusivity until 2025. Patent challenges or biosimilar entries could impact pricing.
Payer Coverage
80% of commercial insurers cover Tucatinib with prior authorization. Coverage expansion is likely as clinical guidelines integrate Tucatinib into standard treatments.
Clinical Guidelines
Inclusion in NCCN guidelines (since 2021) as preferred treatment supports its uptake, influencing pricing and reimbursement.
Pricing Projections (2023-2030)
| Year |
Estimated Price (per 30-day supply) |
Sales Projection |
Market Share % |
| 2023 |
$14,000 |
$300 million |
25% |
| 2024 |
$13,500–$14,000 |
$400 million |
28% |
| 2025 |
$13,500 |
$600 million |
30% |
| 2026 |
$13,000–$13,500 |
$620 million |
28% |
| 2027 |
$12,500–$13,000 |
$650 million |
27% |
| 2028 |
$12,000–$12,500 |
$680 million |
25% |
| 2029 |
$11,500–$12,000 |
$700 million |
23% |
| 2030 |
$11,000–$11,500 |
$720 million |
20% |
Assumptions:
- Slight price erosion driven by biosimilar competition beginning around 2028.
- Stable market share until biosimilar entries disrupt pricing.
- Patent lifespan until 2030 helps maintain current pricing levels.
Risks and Opportunities
Risks
- Patent expiration reduces pricing power.
- Competitive biosimilars may enter market after 2028, exerting downward pressure.
- Changing reimbursement policies could influence net prices.
Opportunities
- Expanding indications increase addressable patient population.
- Combining Tucatinib with novel agents stabilizes market share.
- Global expansion outside the U.S. could diversify revenue streams.
Key Takeaways
- Tucatinib is positioned as a key player in HER2-positive metastatic breast cancer.
- Current price approximates $14,000/month, with a sales forecast steeply rising through 2025.
- Patent protection delays biosimilar competition until ~2030.
- Price stability is based on its strategic clinical positioning and market exclusivity.
- Price erosion anticipated starting around 2028 due to biosimilar activity.
FAQs
1. What are the main competitive advantages of Tucatinib?
Its high selectivity for HER2 makes Tucatinib effective with fewer off-target effects, which allows for combination therapy in heavily pretreated patients and positions it as a preferred option alongside trastuzumab.
2. How does Tucatinib’s price compare to other HER2-targeted therapies?
It is priced lower than Kadcyla or Perjeta but comparable to trastuzumab, reflecting its small molecule nature and manufacturing efficiencies. The $14,000/month rate broadly aligns with targeted therapy benchmarks in oncology.
3. When is biosimilar competition expected?
Patent protections last until 2030, with biosimilar entries likely starting after 2028 following patent challenges or expirations.
4. What factors could influence Tucatinib’s market share?
Emerging clinical data, guideline updates, reimbursement policies, and competitive biosimilar developments will drive adoption rates.
5. Is there potential for expanding Tucatinib’s indications?
Yes; ongoing clinical trials aim to evaluate in earlier lines and other HER2-positive cancers, potentially increasing sales and market penetration.
References
- MarketWatch. (2023). HER2-positive breast cancer therapeutics market size and growth.
- FDA. (2020). Approval announcement for Tucatinib (Tukysa).
- NICE. (2022). Clinical guidelines for HER2-positive breast cancer.
- IQVIA. (2022). Oncology drug sales and pricing analysis.
- Seattle Genetics. (2023). Product dossier and clinical trial data.
