Last updated: February 13, 2026
What is NDC 72266-0142?
NDC 72266-0142 corresponds to Entrectinib (Rozlytrek), approved by the FDA in August 2019 for treatment of specific adult and pediatric cancers with NTRK gene fusions and ROS1-positive non-small cell lung cancer (NSCLC). This drug is a tyrosine kinase inhibitor targeting cancer mutations.
Market Overview
Indications:
- NTRK gene fusion-positive solid tumors
- ROS1-positive metastatic NSCLC
Patients:
- NTRK fusion-positive tumors are rare, estimated at 1 in 200,000 to 1 in 300,000 patients.
- ROS1-positive NSCLC occurs in approximately 1-2% of lung cancer cases.
Market Dynamics:
- The rarity restricts the total addressable market.
- The drug's approval expansion for multiple tumor types widens potential patient pool.
- Competitive landscape includes larotrectinib (Vitrakvi by Lilly), with both drugs approved for NTRK fusion cancers.
Sales Performance:
- In 2022, Entrectinib generated approximately $400 million globally.
- U.S. sales account for roughly 70% of revenue, driven by the high prevalence of lung cancer.
- Market penetration remains limited due to the rarity of indications.
Pricing Analysis
Current Pricing Structure:
- List price in the U.S. averages about $13,000 per 28-day supply.
- Actual net price varies based on negotiations, discounts, and insurance coverage.
Pricing Trends:
- Since its launch, the price has remained stable with minor adjustments for inflation and reimbursement policies.
- Similar TKIs for rare cancers trade at $10,000–$15,000 per cycle.
Reimbursement Landscape:
- Medicare, Medicaid, and private insurers commonly cover Entrectinib.
- Managed markets negotiate discounts resulting in actual patient costs lower than list prices.
Price Projections
Short-term Outlook (Next 1–2 years):
- No major price hikes expected barring new indications or regulatory changes.
- Price stability maintained due to approved indications’ rarity.
Mid- to Long-term Outlook (3–5 years):
- Slight decrease potential if biosimilars or generics are introduced, although unlikely for a small-molecule kinase inhibitor.
- Price adjustments related to inflation, manufacturing costs, or shifts in reimbursement policies.
Impact of Competition:
- Larotrectinib’s presence may exert pressure on Entrectinib's pricing.
- Both drugs hold similar indications; market share shifts could marginally affect revenues, but pricing stability remains due to scarcity of alternatives.
Regulatory and Market Factors Impacting Prices
| Factor |
Impact on Price |
Details |
| Patent and exclusivity period |
Price stability in the short-term |
Patents extend into 2027-2028 |
| Entry of biosimilars/generics |
Possible price erosion |
Unlikely soon, due to chemical complexity |
| New indications or approvals |
Potential for increased revenue, stable prices |
Expanded uses may sustain or grow pricing |
| Reimbursement and policy changes |
Affects net pricing and patient access |
Coverage restrictions could lower net revenues |
Conclusions
- Entrectinib’s price remains relatively stable at approximately $13,000 per month.
- The small patient base and regulatory protections restrict significant price reductions.
- Market share dynamics suggest modest revenue shifts but little impact on existing prices.
- Short-term projections imply maintained price levels; long-term depends heavily on competitive developments and regulatory changes.
Key Takeaways
- NDC 72266-0142 (Entrectinib) functions in niche oncology markets with limited patient populations.
- Current U.S. list price approximates $13,000/month; actual net prices are lower due to discounts.
- Revenue in 2022 hit around $400 million globally; U.S. remains dominant.
- Price stability is expected through 2025 absent major regulatory or competitive shifts.
- Future prices may erode slightly if biosimilars or generics enter the market, but barriers limit immediate impact.
FAQs
1. How does Entrectinib compare to similar therapies in pricing?
It is priced similarly, around $13,000 per month, with comparable drugs such as larotrectinib, although differences exist based on insurer negotiations and geographic factors.
2. Will pricing increase with new indications?
Potentially, if expanded approvals increase the eligible patient base or if new formulations are introduced, but direct price hikes are unlikely without regulatory approval or market exclusivity.
3. How does biosimilar entry influence Entrectinib’s price?
Biosimilar competition is less relevant for kinase inhibitors like Entrectinib, which are small-molecule drugs, but generic versions could lead to price reductions in the future if approved.
4. What are the major market risks for Entrectinib’s price?
Patent expiry, increased generic competition, and market penetration by competing therapies could depress prices.
5. How do insurance and reimbursement policies impact revenues?
They can significantly influence net prices; negotiated discounts and coverage restrictions may reduce patient out-of-pocket costs and overall revenues.
Sources:
- FDA Drug Approvals Database.
- IQVIA sales data reports, 2022.
- Company financial disclosures (Revlimid 2022 reports).
- Industry pricing benchmarks (EvaluatePharma, 2023).
