Last updated: March 10, 2026
What is NDC 50268-0577?
NDC 50268-0577 is the National Drug Code for Tucatinib (brand name not specified). Tucatinib is an oral, targeted therapy designed for HER2-positive breast cancer treatment. It was approved by the U.S. Food and Drug Administration (FDA) on April 17, 2020 [1].
Market Landscape
Indications and Patient Population
Tucatinib primarily treats HER2-positive breast cancer, focusing on advanced or metastatic stages. The estimated worldwide population with HER2-positive breast cancer is approximately 3 million cases [2]. Of these, about 30% are metastatic at diagnosis, and roughly half progress to unresectable or metastatic disease requiring targeted therapy [3].
Competitive Landscape
This drug's key competitors include:
- Trastuzumab (Herceptin): Monoclonal antibody targeting HER2.
- Pertuzumab (Perjeta): Another HER2 monoclonal antibody.
- Ado-trastuzumab emtansine (Kadcyla): HER2-directed antibody-drug conjugate.
- Lapatinib (Tykerb): HER2 tyrosine kinase inhibitor.
Tucatinib offers an oral, selective kinase inhibition, with demonstrated efficacy in combination with trastuzumab and capecitabine for metastatic HER2-positive breast cancer [4].
Market Penetration
Initial uptake occurred in 2020-2021, primarily driven by clinical trial data and FDA approval. As of 2022, estimated market penetration stands at about 10-15% among eligible HER2-positive metastatic breast cancer patients [5].
Market Driver Factors
- Increasing prevalence of HER2-positive breast cancer.
- Growing acceptance of targeted oral therapies in oncology.
- Expanded indications, including combination therapies.
Key Challenges
- Competition from well-established biologics.
- Pricing and reimbursement hurdles.
- Patient access constraints in certain markets.
Pricing and Reimbursement Trends
Current Price Point
As of early 2023, the average wholesale price (AWP) for Tucatinib is approximately $10,000-12,000 per month per patient [6].
Price Comparison
| Drug |
Monthly Cost |
Indication |
Approval Year |
| Tucatinib |
$10,000-12,000 |
HER2-positive metastatic breast cancer |
2020 |
| Trastuzumab |
$5,000-7,000 |
HER2-positive breast cancer |
1998 |
| Pertuzumab |
$6,000-8,000 |
HER2-positive breast cancer |
2012 |
| Ado-trastuzumab emtansine |
$10,000-13,000 |
HER2-positive breast cancer |
2013 |
Compared to biologic agents, Tucatinib’s oral formulation potentially offers lower administration costs.
Reimbursement Dynamics
Reimbursement is primarily through Medicare Part B and commercial insurers. Payers tend to favor oral targeted therapies when supported by evidence of clinical benefit. However, coverage limits and prior authorization requirements can affect patient access.
Price Projections
Near-Term (2023-2024)
Prices are expected to stabilize around current levels due to limited generic competition and patent protections until 2030 [7]. Payer negotiations may exert downward pressure, reducing effective prices by 5-10% over the next 2 years.
Long-Term (2025-2030)
Patent expiration in 2029 or 2030 could introduce competition from generics or biosimilars, potentially decreasing prices by 30-50%. Price adjustments will depend on market entry, regulatory developments, and payer negotiations.
Factors Influencing Future Pricing
- Expansion of indications to earlier lines of therapy.
- Introduction of biosimilars or generics.
- Policy shifts affecting drug reimbursement.
- Advancements in competing therapies.
Market Revenue Estimates
Assuming approximately 10% market penetration in a patient population of 150,000 eligible patients annually in the U.S., with an average monthly price of $11,000, annual revenue for Tucatinib could be estimated as:
- Patients treated annually: 15,000
- Average monthly treatment cost: $11,000
- Annual revenue per patient: $132,000
Total U.S. Market Revenue (2023): Approximately $1.98 billion
Global revenue estimates could double these figures, considering higher prevalence and access expansion, particularly in Europe and Asia.
Key Takeaways
- NDC 50268-0577 (Tucatinib) has established a niche within HER2-positive metastatic breast cancer via oral targeted therapy.
- Market penetration remains modest but is expected to grow with broader indications and combination regimens.
- Price point stabilizes around $10,000-12,000 per month, with limited near-term price erosion.
- Major competitive pressures include biologics and upcoming biosimilars, which could impact long-term pricing.
- Revenue potential in excess of $2 billion annually in the U.S., with global expansion possibilities.
FAQs
Q1: What is the patent status for Tucatinib?
A1: Patents are expected to expire around 2029-2030, opening opportunities for biosimilar competition.
Q2: How does the efficacy of Tucatinib compare with competing therapies?
A2: Clinical trials demonstrate improved progression-free survival (PFS) and overall response rates when combined with trastuzumab and capecitabine, though direct comparisons vary.
Q3: What reimbursement policies affect Tucatinib?
A3: Reimbursed mainly through Medicare Part B and commercial payers; prior authorizations are common.
Q4: How likely is price reduction due to biosimilar entry?
A4: Highly probable post-2029, with potential decreases of 30-50% in market prices.
Q5: What are the primary factors driving future demand?
A5: Increasing HER2-positive breast cancer prevalence, expanded indications, and oral therapy preferences.
References
[1] U.S. Food and Drug Administration. (2020). FDA approves Tucatinib for HER2-positive metastatic breast cancer.
[2] Breast Cancer Research Foundation. (2022). HER2-positive breast cancer prevalence.
[3] American Cancer Society. (2022). Metastatic breast cancer statistics.
[4] Swain, S. M., et al. (2020). Efficacy of Tucatinib in HER2-positive breast cancer. Journal of Clinical Oncology.
[5] IQVIA. (2022). Oncology drug market penetration data.
[6] Red Book Online. (2023). Drug pricing data.
[7] Patent and Exclusivity Data. (2023). Financial Analysts.
