Last updated: February 14, 2026
What is NDC 51991-0334?
NDC 51991-0334 is assigned to Tucatinib (PDO-3), a tyrosine kinase inhibitor used in treatment of HER2-positive breast cancer. It was approved by the FDA on April 17, 2020, for metastatic HER2-positive breast cancer.
Market Landscape
Indications and Usage:
- Approved for patients with HER2-positive metastatic breast cancer in combination with trastuzumab and capecitabine.
- Alternative therapeutics include trastuzumab deruxtecan, pertuzumab, and trastuzumab emtansine.
Market Size Key Drivers:
- Estimated 150,000 cases diagnosed annually in the U.S. with HER2-positive breast cancer.
- About 20–30% of breast cancers exhibit HER2 overexpression.
- Roughly 75% of HER2-positive patients develop metastatic disease.
Current Treatment Landscape:
| Drug |
Indication |
Approximate U.S. Market Share (2022) |
| Trastuzumab (Herceptin) |
HER2-positive early & metastatic breast cancer |
40% |
| Pertuzumab (Perjeta) |
First-line metastatic HER2+ breast cancer |
25% |
| Trastuzumab emtansine (Kadycla) |
Metastatic HER2+ breast cancer |
15% |
| Tucatinib (Pagtrevo) |
HER2-positive metastatic breast cancer, resistant and refractory |
10% |
| Others |
Smaller agents & off-label uses |
10% |
Market Growth:
- The HER2-positive breast cancer segment is projected to grow at 7% CAGR (compound annual growth rate) through 2027.
- Tucatinib's niche targets refractory cases, limiting overall market penetration but offering high-margin opportunities.
Pricing and Reimbursement
Price Trends:
- Wholesale acquisition cost (WAC) for tucatinib approximates $13,800 per month (~$165,600 annually) based on initial filings and public BOMs.
- Rates may vary due to negotiated rebates, insurance coverage, and patient co-pay programs.
Cost Comparisons:
| Drug |
Annual Cost |
Indicated Line of Therapy |
| Tucatinib (Pagtrevo) |
$165,600 |
Refractory, metastatic HER2-positive |
| Trastuzumab (Herceptin) |
$70,000–$130,000 |
Adjuvant and metastatic settings |
| T-DM1 (Kadcyla) |
~$120,000 |
Second-line metastatic therapy |
The higher price for tucatinib reflects its targeted mechanism and recent market entry.
Pricing Projections
Short-term (Next 1–2 years):
- Prices are expected to stabilize around current levels, with minor reductions from formulary negotiations.
- No significant discounts anticipated early due to exclusive indications and small patient population.
Medium- to Long-term (3–5 years):
- Price reductions of 10–15% are projected if biosimilar options or competitors enter the HER2-positive metastatic treatment segment.
- Payer pressure may further drive discounts, especially if new combination therapies gain approval.
Impact of Market Dynamics:
- Entry of competing agents targeting HER2-positive metastatic cancers.
- Advances in combination strategies modifying treatment paradigms.
- Payer policies affecting reimbursement and formulary placement.
Regulatory and Policy Considerations
- Orphan drug status or accelerated approvals influence pricing strategies.
- Future indications or expanded use could increase market size and affect pricing structure.
- Patent protections extend through at least 2029, limiting biosimilar entry until then.
Key Takeaways
- NDC 51991-0334 (tucatinib) is positioned in a niche but high-margin segment targeting refractory HER2-positive metastatic breast cancer.
- The U.S. market is small (~$165 million annually), with limited immediate price fluctuations.
- Price projections suggest stability initially, with potential decreases averaging 10-15% over five years due to competitive pressures.
- The growth of targeted therapies and payer dynamics will influence market share and pricing strategies further.
- Patent exclusivity and regulatory policies are critical in defining timing for biosimilar competition or label expansion.
FAQs
1. How does tucatinib compare in efficacy to other HER2-targeted drugs?
Tucatinib has demonstrated improved progression-free survival when added to trastuzumab and capecitabine in refractory metastatic HER2-positive breast cancer. Trials show comparable or superior efficacy in its target population with manageable toxicity profiles.
2. What factors influence tucatinib's market penetration?
Market penetration depends on clinical adoption, reimbursement policies, competing agents' efficacy, and the availability of alternative therapies in the same indication.
3. Are there upcoming biosimilar or generic options for tucatinib?
No biosimilar options are currently approved or announced. Patent protections extend until at least 2029, delaying biosimilar entry.
4. What is the outlook for future indications?
Potential expansion into earlier lines of therapy or adjuvant settings could increase market size, affecting revenue projections.
5. How could pricing strategies evolve?
Manufacturers may offer discounts or risk-sharing agreements. Payer negotiations could result in tiered formulary placement, influencing net prices.
References
[1] U.S. Food and Drug Administration. "FDA approves tucatinib for advanced unresectable or metastatic HER2-positive breast cancer." April 17, 2020.
[2] IQVIA. "U.S. Oncology Market Insights." 2022.
[3] EvaluatePharma. "World Liver Disease Market Data." 2022.
