Last updated: March 13, 2026
What is NDC 51672-1309?
NDC 51672-1309 is a proprietary drug. Based on publicly available data, this NDC corresponds to entrectinib (Rozlytrek), developed by Genentech/Roche. Entrectinib targets ROS1, NTRK gene fusions, and ALK-positive tumors.
Market Size and Growth Drivers
Current Market Landscape
| Market Segment |
Estimated Revenue (2022) |
Market Share |
Key Competitors |
| ROS1-positive NSCLC |
$600 million |
40% |
Crizotinib, Lorlatinib |
| NTRK fusion tumors |
$350 million |
25% |
Larotrectinib, entrectinib |
| ALK-positive tumors |
$250 million |
20% |
Alectinib, Brigatinib |
Note: Data sourced from Pharmaprojects, 2022.
Growth Drivers
- Increased identification of gene fusions via next-generation sequencing (NGS).
- Expansion of indications beyond NSCLC to include solid tumors and pediatric cancers.
- Growing adoption of precision medicine, with multiple regulatory approvals since 2019.
Market Trends
- Compound Annual Growth Rate (CAGR): projected at 15% from 2022 to 2027.
- Off-label use shaping future revenue streams.
- Clinical pipeline expansion for combination regimens.
Pricing Overview
Current Price Points
| Formulation |
Typical Wholesale Price |
Per-Unit Price (Approximate) |
Remarks |
| 60 mg capsules |
$14,000 / month |
$14,000 |
Average wholesale for 28-day supply |
| 100 mg capsules |
$17,000 / month |
$17,000 |
Higher dose, for adult indications |
Source: RedBook, 2022, adjusted for average wholesale price (AWP).
Price Trends
- No significant recent price drops despite increased competition.
- Premium pricing maintained due to targeted therapy status and orphan drug designation.
- Price levels similar to larotrectinib, but with higher associated costs in some indications.
Regulatory and Market Access Factors
- FDA approvals: 2019 for ROS1-positive NSCLC, 2020 for NTRK fusion solid tumors.
- Pricing and reimbursement: Favorable due to breakthrough therapy and orphan status.
- Pricing strategies: Used to offset high R&D costs; no major discounts reported.
Future Price Projections
| Year |
Estimated Price Range |
Rationale |
| 2023 |
$13,500 - $17,000 |
Stable pricing with minor competitive pressures |
| 2024 |
$13,000 - $16,500 |
Potential negotiation with payers; market expansion |
| 2025 |
$12,500 - $16,000 |
Increased competition from Larotrectinib and emerging pipeline agents |
Projected declines limited by patent exclusivity until at least 2027, barring patent challenges or regulatory changes.
Competitive Landscape
| Drug Name |
Developer |
Indications |
Market Position |
Price Comparison |
| Entrectinib |
Roche |
ROS1, NTRK, ALK-positive tumors |
Market leader in NTRK |
Higher due to targeted high-value indication |
| Larotrectinib |
Bayer |
NTRK fusion tumors |
Direct competitor |
Slightly lower, but similar in pricing |
| Crizotinib |
Pfizer |
ROS1, ALK-positive NSCLC |
Off-label competitor |
Lower, but less effective in some cases |
Market Entry and Investment Considerations
- Patent protection extends until at least 2027, with potential for extension based on terminality and patent applications.
- Biosimilar or generic entry unlikely before expiration, given the biologic nature.
- Market expansion depends on positive enrollment of ongoing clinical trials and label expansion in pediatric indications.
Key Takeaways
- NDC 51672-1309 (entrectinib) commands a premium price due to its targeted mechanism and regulatory status.
- Market is growing at a 15% CAGR, driven by gene fusion diagnostics and expanding indications.
- Price projections indicate stability through 2024 with slight declines expected from increased competition.
- Limited risk of generic competition before 2027 due to biologic patent protections.
- Investment and R&D should focus on indication expansion and pipeline development.
FAQs
Q1: What factors influence entrectinib’s pricing stability?
Regulatory exclusivity, high development costs, and targeting a niche patient population sustain premium pricing.
Q2: How does entrectinib compare price-wise to other targeted therapies?
It is generally priced higher than similar small-molecule kinase inhibitors due to its targeted patient population and orphan drug status.
Q3: Will emerging competitors impact entrectinib’s market share?
Yes, especially larotrectinib, which targets NTRK fusions with similar efficacy, could influence market share.
Q4: What is the outlook for pricing after patent expiration?
Prices are expected to decline with the entry of biosimilars or generics, though biologic patent expirations are rare before 2027.
Q5: Which indications are most financially impactful for entrectinib?
ROS1-positive non-small cell lung cancer (NSCLC) and NTRK fusion tumors account for the majority of revenue.
References
[1] Pharmaprojects. (2022). Market data and forecasts.
[2] RedBook. (2022). Wholesale prices for biologics and targeted therapies.
[3] FDA. (2019-2022). Approvals and regulatory filings.
[4] IQVIA. (2022). Market share and sales reports.
[5] EvaluatePharma. (2022). Oncology drug forecasts for 2022-2027.
