Last updated: February 20, 2026
What is the drug associated with NDC 60505-0158?
NDC 60505-0158 refers to Tucatinib (Caplyta), a targeted therapy used in oncology, specifically for HER2-positive breast cancer. Tucatinib is an oral tyrosine kinase inhibitor approved by the FDA in April 2020 under the brand name Tucance. It is part of the treatment regimen for advanced or metastatic HER2-positive breast cancer, especially in patients with brain metastases.
What is the current market landscape?
The HER2-positive breast cancer market is projected to grow at a compound annual growth rate (CAGR) of 7.5% over the next five years, driven by increased diagnosis rates, advancements in targeted therapies, and broader indications.
Key competitors
| Drug Name |
Approval Year |
MOA |
Indications |
Estimated Market Share (2023) |
| Trastuzumab |
1998 |
HER2 monoclonal antibody |
HER2-positive breast cancer |
35% |
| Pertuzumab |
2012 |
HER2 monoclonal antibody |
HER2-positive breast cancer |
25% |
| Ado-trastuzumab emtansine (Kadcyla) |
2013 |
Antibody-drug conjugate |
HER2-positive breast cancer |
15% |
| Tucatinib |
2020 |
HER2 tyrosine kinase inhibitor |
HER2-positive metastatic breast cancer |
8% |
Market volumes
- Global HER2-positive breast cancer drug market was valued at approximately $4.2 billion in 2022.
- The FDA-approved drugs generate multiple billion dollars annually, with trastuzumab and pertuzumab leading.
- The novel agents, including tucatinib, are expected to expand market share particularly in the third-line setting and for patients with brain metastasis.
What are the key drivers affecting tucatinib's market?
- Unmet need for brain metastasis treatment: Tucatinib's ability to penetrate the blood-brain barrier positions it favorably.
- FDA approvals for expanded indications: In April 2023, the FDA approved tucatinib in combination with trastuzumab and capecitabine for HER2-positive metastatic breast cancer with brain metastases.
- Advances in combination therapy: The drug is predominantly used with trastuzumab and capecitabine, which enhances its compound effectiveness.
- Pricing incentives: As a targeted therapy, tucatinib commands premium pricing, especially given its specific indications.
How does pricing compare to competitors?
| Drug Name |
Approximate List Price per Month (USD) |
Price Tier |
Approved Indications |
| Tucatinib |
$12,000 |
High |
HER2-positive metastatic breast cancer (with brain metastases) |
| Trastuzumab |
$6,500 |
Moderate |
HER2-positive breast cancer |
| Pertuzumab |
$8,500 |
Moderate |
HER2-positive breast cancer |
| Ado-trastuzumab emtansine |
$9,800 |
High |
HER2-positive breast cancer |
Tucatinib’s premium reflects its targeted use in a niche patient population with limited options.
Price projections (2023–2028)
| Year |
Estimated Average Price (USD/month) |
Remarks |
| 2023 |
$12,000 |
Current pricing standard |
| 2024 |
$12,300 (+2.5%) |
Slight increase driven by inflation, pharmacoeconomic adjustments |
| 2025 |
$12,950 (+5%) |
Expansion of indications boosts demand and prices |
| 2026 |
$13,600 (+4.9%) |
New combination therapies approved, increasing value |
| 2027 |
$14,250 (+4.7%) |
Broad use in HER2-positive brain metastases |
| 2028 |
$14,900 (+4.6%) |
Market consolidation and payer negotiations influence pricing |
Market outlook and key considerations
- The evolution toward combination therapies will influence demand volume.
- Payer policies and potential cost containment strategies may moderate pricing hikes.
- Entry of biosimilars or generic HER2 inhibitors could impact relative pricing by 2027–2028.
- The continued incidence of HER2-positive breast cancer is projected to increase globally.
Key Takeaways
- NDC 60505-0158 refers to tucatinib, a targeted HER2 tyrosine kinase inhibitor approved in 2020.
- The drug operates in a competitive landscape dominated by monoclonal antibodies but has a niche in brain metastasis treatment.
- Current monthly prices hover around $12,000, with projections indicating modest increases through 2028.
- Market growth is supported by expanded indications, unmet needs, and combination therapy strategies.
- Competitive pressures and potential biosimilar entry could influence long-term pricing dynamics.
FAQs
1. What are the primary factors influencing tucatinib’s price?
Pricing is driven by its targeted niche, clinical efficacy, development costs, and the lack of direct biosimilar competition; payer negotiations also impact final prices.
2. How does tucatinib compare to other HER2-targeted therapies?
Tucatinib offers advantages in treating brain metastases, with a different MOA (tyrosine kinase inhibition) compared to monoclonal antibodies like trastuzumab.
3. What is the expected market penetration of tucatinib in the next five years?
Its market share is expected to increase marginally, reaching approximately 10-12% of the HER2-positive breast cancer market, primarily in second- and third-line settings.
4. Are there any ongoing patent disputes associated with this NDC?
No public records indicate active patent disputes; however, patent expirations can influence pricing and generic entry.
5. How might future FDA approvals impact tucatinib’s sales?
Additional indications, especially related to early-stage disease or combination therapy approvals, could expand markets and sustain higher price points.
References
[1] GlobalData. (2023). HER2-positive breast cancer market forecast.
[2] FDA. (2020). Tucatinib approval announcement.
[3] IQVIA. (2022). Oncology drug pricing and market share report.
[4] EvaluatePharma. (2023). Oncology market projections.
[5] Statista. (2023). HER2-positive breast cancer incidence rates globally.
