Last updated: February 16, 2026
What is NDC 68462-0842?
NDC 68462-0842 identifies Tucatinib (brand name: Tukysa). It is an oral tyrosine kinase inhibitor approved for the treatment of HER2-positive metastatic breast cancer, including cases with brain metastases. The drug is marketed by Seattle Genetics and has gained regulatory approval from the FDA since April 2020.
Market Landscape
Indications and Patient Population
- Approved for HER2-positive metastatic breast cancer.
- Addressable population: approximately 150,000 new breast cancer cases annually in the U.S., with an estimated 15-20% HER2-positive.
- Estimated eligible patients in the U.S.: 22,500 annually.
Competitive Environment
- Main competitors include trastuzumab deruxtecan (Enhertu), neratinib (Nerlynx), and other anti-HER2 therapies.
- Tucatinib differentiates itself through oral administration and CNS activity, addressing brain metastases, a common complication in HER2-positive breast cancer.
Market Adoption Factors
- Rapid approval in 2020.
- Positive clinical trial data demonstrating efficacy in brain metastases.
- Partnerships and launch strategies by Seattle Genetics and collaborators.
Market Penetration Data
- Initial market uptake remains moderate owing to the niche indication.
- Sales grew from $20 million in 2020 to approximately $150 million in 2022.
- Projected global sales could reach $300-400 million by 2025, contingent on expansion into other HER2-positive cancers.
Price Analysis
Current Pricing
- The wholesale acquisition cost (WAC) for Tukysa (per pill) is approximately $230.
- Monthly treatment cost for an average patient (assuming 300 mg daily dose): around $6,900.
- The average wholesale price (AWP) can be higher, roughly $8,000 per month.
| Pricing Compared to Competitors |
Drug |
Price (per month) |
Indication |
Delivery Method |
| Tucatinib (Tukysa) |
$8,000 |
HER2-positive breast cancer |
Oral |
| Trastuzumab (Herceptin) |
$5,000 - $6,000 |
HER2-positive breast cancer |
IV infusion |
| Neratinib (Nerlynx) |
$7,500 |
HER2-positive early and metastatic |
Oral |
| Trastuzumab deruxtecan |
$14,500 |
HER2-positive breast cancer |
IV infusion |
Pricing Considerations
- The premium over intravenous therapeutics is justified by oral convenience and CNS activity.
- Reimbursement trends favor value-based pricing; thus, discounts and patient assistance programs influence net prices.
Pricing Projections
Short-term (2023-2025)
- Stable pricing in the range of $7,500 - $8,500 per month.
- No significant price cuts expected; pricing may increase slightly annually (2-3%) due to inflation and market demand.
Medium-term (2025-2030)
- Possible price stabilization or slight reduction as biosimilars or new entrants emerge.
- Price reductions of 10-15% may occur if payer pressure increases or generic combinations are developed.
Long-term (2030 and beyond)
- Patent expiry forecasted around 2038.
- Entry of generics or biosimilars would decrease prices substantially, possibly by 50-60%.
Regulatory and Market Challenges
- Patent protections are crucial; loss of exclusivity would reduce prices.
- Payer reimbursement policies significantly influence market penetration and net sales.
- Competitor innovation or new combinations could alter desirability and pricing strategies.
Key Takeaways
- NDC 68462-0842 (Tucatinib) is a niche drug with growing demand driven by efficacy in brain metastases.
- Current annual sales reach approximately $150 million in the U.S., with expansion potential.
- Wholesale prices are around $8,000/month, aligning with targeted oncology drugs.
- Price stability is expected short-term; long-term prices may decline following patent expiration.
- Competitive landscape and payer policies are primary factors influencing future valuation.
FAQs
1. How does Tucatinib compare to other HER2-targeted therapies in terms of price?
Tucatinib's monthly price of approximately $8,000 is higher than trastuzumab but lower than trastuzumab deruxtecan.
2. What factors could influence Tucatinib's future pricing?
Patent expiration, market competition, payer negotiations, and new drug approvals.
3. Is there potential for price increases?
Yes, if demand increases or supply chain costs rise; however, price hikes are typically limited in oncology drugs.
4. How sensitive is the market to biosimilars or generics?
Highly sensitive; entry of biosimilars or generics could reduce prices by 50% or more.
5. What is the outlook for market growth?
Sales are projected to grow to $300-400 million globally by 2025, driven by increased adoption and expanded indications.
References
- FDA Approval Announcement for Tucatinib [1].
- Market Reports on HER2-positive Breast Cancer Drugs [2].
- Pricing Data from IQVIA and Pharmaceutical Pricing Reports [3].
- Competitive Analysis for Oncology Drugs [4].
- Patent Expiry and Biosimilar Entry Announcements [5].
[1] U.S. Food and Drug Administration. “FDA Approves Tucatinib for HER2-Positive Breast Cancer.” 2020.
[2] MarketWatch. “HER2-positive breast cancer therapeutics market forecast 2022-2025.”
[3] IQVIA. “Pharmaceutical Pricing & Market Dynamics Report 2022.”
[4] EvaluatePharma. “Oncology Drug Market Competition Analysis 2023.”
[5] Drugs.com. “Patent Expiry Calendar and Biosimilar Impact Assessments.”
