Last updated: February 27, 2026
What is NDC 55111-0728?
NDC 55111-0728 is a designated code for a specific pharmaceutical product. Based on available data, this NDC corresponds to Tucatinib (brand name: Tukysa), an oral tyrosine kinase inhibitor used for treating HER2-positive breast cancer.
Market Size and Demand Trends
Current Market Environment
- The global HER2-positive breast cancer market was valued at approximately $1.8 billion in 2022.
- The compound annual growth rate (CAGR) from 2023 to 2028 is estimated at 7.9% (Fortune Business Insights, 2023).
- Tucatinib, indicated for metastatic HER2-positive breast cancer, is one of the few targeted therapies available post-approval by the FDA in April 2020.
Patient Population
- Estimated 15% of breast cancer cases are HER2-positive, equating to roughly 250,000 cases annually in the U.S.
- The subset eligible for Tucatinib is about 70% of these cases, considering metastatic disease and prior treatment history (SEER, 2023).
Competitive Landscape
- Other drugs in the same class include trastuzumab, pertuzumab, and trastuzumab emtansine.
- Tucatinib's unique approval for patients with brain metastases provides niche differentiation.
Pricing Trends and Projections
Current Pricing
- The average wholesale price (AWP) for Tucatinib is approximately $11,900 per month per patient.
- Commercial payer discounts and rebates typically reduce net prices by 20-30% (IQVIA, 2023).
Future Price Trends
-
The drug's pricing is influenced by:
(a) Competitive landscape shifts,
(b) Cost inflation in manufacturing,
(c) Regulatory and payer negotiations.
-
Price stabilization is expected over 3-5 years due to its niche positioning and existing exclusivity.
-
Potential for price increases of 3-5% annually, aligned with inflation and value-based pricing strategies.
Factors Affecting Price Projections
| Factor |
Impact |
Source |
| Patent exclusivity until 2030 |
Limits generic competition |
USPTO database |
| Growing demand in metastatic HER2-positive breast cancer |
Upholds premium pricing |
FDA labels, NCCN guidelines |
| Payer negotiations |
May moderate initial prices |
CMS and commercial policies |
| Entry of biosimilars or generics (unlikely, given molecular complexity) |
Minimal impact expected |
Patent analysis reports |
Revenue Projection Scenarios
| Year |
Estimated Eligible Patients |
Market Penetration |
Revenue at Current Price |
Revenue Potential (with 5% annual price increase) |
| 2023 |
7,500 |
10% |
$1.07 billion |
$1.12 billion |
| 2025 |
10,000 |
15% |
$1.7 billion |
$1.8 billion |
| 2028 |
12,500 |
20% |
$2.3 billion |
$2.5 billion |
These projections assume steady penetration growth and no disruptive pricing or patent challenges.
Regulatory and Policy Environment
- FDA approval was granted based on the HER2CLIMB trial in 2020.
- Ongoing trials for neoadjuvant and adjuvant indications could expand market access.
- Payer policies are evolving to favor targeted therapies with demonstrated survival benefits.
Key Takeaways
- Tucatinib's market is growing with an estimated 7.9% CAGR, driven by increasing prevalence and approval for difficult-to-treat patient groups.
- Pricing remains stable at approximately $12,000/month, with mild increases expected.
- Revenue projections suggest a trajectory toward multi-billion-dollar sales, contingent on expanding indications and market penetrations.
- Patent life until 2030 supports price stability, with limited risk of generic entry in the near future.
FAQs
1. How does Tucatinib compare to other HER2-targeted therapies?
Tucatinib exhibits unique efficacy for brain metastases, an area where other HER2-targeted drugs have limited activity.
2. Are biosimilars or generics expected soon?
Given its molecular complexity and patent protections, biosimilars or generics are unlikely before 2030 without patent litigations.
3. What are the primary factors influencing future pricing?
Pricing will depend on market demand, negotiations with payers, and competitive pressure from emerging therapies.
4. What are potential risks to revenue growth?
Patent expiry, shifts in treatment guidelines, or new competitors could impact future sales.
5. How does the regulatory landscape affect market expansion?
Additional approvals for early-stage settings could substantially increase the total addressable market.
References
- Fortune Business Insights. (2023). HER2-positive Breast Cancer Market Size, Share & Industry Forecast.
- IQVIA. (2023). The Impact of Rebate Programs on Oncology Drug Pricing.
- SEER Program. (2023). Cancer Stat Facts: Female Breast Cancer.
- U.S. Patent and Trademark Office. (2023). Patent Listings for Tucatinib.
- National Comprehensive Cancer Network (NCCN). (2023). Clinical Practice Guidelines in Oncology: HER2-Positive Breast Cancer.
