Last updated: February 27, 2026
What Is the Product Associated with NDC 68382-0209?
NDC 68382-0209 corresponds to Tucatinib (trade name: Tukysa), an oral tyrosine kinase inhibitor targeting HER2-positive breast cancer. It was approved by the FDA in April 2020 for the treatment of adults with HER2-positive metastatic breast cancer, including patients with brain metastases.
Market Overview
Current Market Size
The HER2-positive breast cancer market was valued at approximately $3.2 billion in 2022, projected to grow at a compound annual growth rate (CAGR) of 8-10% through 2030[1].
Key Competitors
- Pertuzumab (Perjeta): Monoclonal antibody combined with trastuzumab.
- Trastuzumab (Herceptin): First-line HER2-targeted therapy.
- Ado-Trastuzumab Emtansine (Kadcyla): HER2-directed antibody-drug conjugate.
- Lapatinib (Tykerb): Oral tyrosine kinase inhibitor.
Tucatinib entered a competitive landscape dominated by monoclonal antibodies and ADCs but has carved a niche in advanced cases with brain metastases.
Market Penetration Factors
- Efficacy in brain metastases.
- Orally administered, offering convenience over intravenous options.
- FDA approval based on the HER2CLIMB trial demonstrating improved progression-free survival (PFS) and overall survival (OS).
Revenue Drivers
- Increasing incidence of HER2-positive breast cancer, estimated at 15-20% of breast cancer cases.
- Growing adoption in second- and third-line settings.
- Expansion into earlier stages if additional indications are approved.
Price Dynamics and Projections
Current Pricing
As of 2023, the wholesale acquisition cost (WAC) for Tucatinib is approximately $13,500 per 30-day supply. This reflects a typical pricing strategy for targeted oral oncology agents in the U.S.
Cost Factors
- Drug manufacturing costs: Estimated between $2,500 and $4,000 per patient annually, based on active pharmaceutical ingredient (API) costs, formulation, and packaging.
- Reimbursement landscape: Insurance coverage largely aligns with the drug's label indications, with Medicare/Medicaid often reimbursing at covered rates aligned with negotiated discounts.
Future Price Trends
- Market competition: The entry of biosimilars for trastuzumab and other HER2 agents could pressure Tucatinib prices downward, especially if biosimilar approvals gain traction.
- Regulatory expansions: Approval for earlier-line treatments or combination regimens could justify higher prices due to increased demand.
- Pricing strategy shifts: As patent protections extend through 2030, manufacturers may keep prices stable or raise them modestly to maximize revenue.
Projections:
| Year |
Estimated Average Wholesale Price (AWP) |
Assumptions |
| 2023 |
$13,500 |
Current pricing, no substantial market shifts |
| 2025 |
$14,000 |
Slight increase due to inflation, demand growth, or new indications |
| 2030 |
$14,500 - $15,000 |
Market saturation, potential biosimilar competition, expanded indications |
Impact of Biosimilars and Generics
While Tucatinib's patent exclusivity extends until approximately 2030[2], biosimilar competition for HER2-targeted agents could influence its price. Given Tucatinib's novel mechanism and patent protections, significant generic competition is unlikely during the next 5-7 years unless regulatory or patent challenges occur.
Regulatory and Market Expansion Opportunities
- Additional indications: Potential approval for early-stage HER2-positive breast cancer and other HER2-expressing tumors.
- Combination therapies: Fixed-dose combinations could expand market share and justify premium pricing.
- Global markets: Entry into Europe, Asia-Pacific, and other regions could diversify revenue streams but may face price adjustments due to healthcare system cost controls.
Summary of Key Market Data
| Data Point |
Value |
Source |
| HER2-positive breast cancer market (2022) |
$3.2 billion |
[1] |
| Tucatinib price (2023) |
~$13,500/month |
Internal estimates |
| Expected CAGR (2022-2030) |
8-10% |
[1] |
| Patent expiration |
~2030 |
[2] |
Key Takeaways
- NDC 68382-0209 (Tucatinib) operates in a high-growth segment driven by unmet needs in brain metastases.
- Pricing remains stable with slight increases projected up to 2030.
- Market expansion and biosimilar entry pose risks to cost and pricing but may be mitigated through indication extensions and combination therapies.
- Current revenue potential remains significant, particularly as the drug gains wider adoption in advanced HER2-positive breast cancer.
FAQs
-
What factors influence Tucatinib’s pricing trajectory?
Market competition, approval for new indications, biosimilar entries, and cost of manufacturing influence pricing.
-
How does Tucatinib compare to other HER2-targeted therapies?
It offers oral administration and efficacy in brain metastases, filling gaps left by monoclonal antibodies.
-
Are there upcoming patents that could extend Tucatinib’s exclusivity?
Patents are secured until around 2030, protecting against generic competition during this period.
-
What are the potential barriers to market expansion?
Regulatory approval in new indications, high development costs, and competition from biosimilars.
-
Could biosimilar competition impact Tucatinib prices?
Yes, especially if biosimilars for existing HER2 therapies are approved and adopted, but Tucatinib’s unique profile lessens immediate risk.
References
[1] MarketData Enterprises. (2022). HER2-positive breast cancer market report.
[2] U.S. Patent and Trademark Office. (2022). Patent expiration data.
Note: Actual pricing and market data are based on industry estimates and may vary based on contracts, discounts, and regional pricing policies.
