Last updated: February 24, 2026
What is NDC 50111-0648?
NDC 50111-0648 refers to Entrectinib (Rozlytrek), a targeted therapy approved for oncological indications. Licensed by Roche, this drug is used primarily for the treatment of ROS1-positive non-small cell lung cancer (NSCLC), ROS1-positive metastatic NSCLC, and certain solid tumors containing NTRK gene fusions.
Market Overview
Market Size and Key Drivers
- Indications: Approved indications include ROS1-positive NSCLC and NTRK gene fusion-positive solid tumors.
- Patient Population: Estimated to be 4,000-6,000 globally for eligible NSCLC patients and approximately 2,000-3,000 for NTRK fusion-positive tumors.
- Market Penetration: Already established as a first-line therapy in specific genetic cancer subtypes; adoption driven by genetic testing rates and clinician awareness.
- Competitive Landscape: Competes with other targeted therapies like Crizotinib, Entrectinib’s successor entrectinib (Rozlytrek) faces competition from larotrectinib (Vitrax), another NTRK inhibitor.
Clinical and Regulatory Status
- FDA Approval: August 2019 for ROS1-positive metastatic NSCLC.
- EMA: Approved in Europe in 2020.
- Companion Diagnostics: Requires NTRK fusion testing via FISH or NGS platforms.
Market Trends
- Rising adoption of comprehensive genomic profiling elevates patient identification.
- Expansion into additional tumor types, pending ongoing trials.
- Increasing incidence of targeted therapy use in advanced cancer treatment pathways.
Revenue and Pricing Data
Current Price Points
| Region |
List Price per 30-day supply |
Notes |
| US |
$17,000 - $20,000 |
Approximate, varies by payer and formulation |
| Europe |
€15,000 - €18,000 |
Different pricing structures across countries |
| Japan |
¥2,000,000 |
Fixed, negotiated pricing in Japanese market |
Price Components
- Standard dosing involves oral administration of 600 mg daily.
- Package sizes and dosing instructions influence per-unit pricing.
- Discounts and rebates impact actual net prices across payers.
Market Revenue Estimates
| Year |
Estimated Global Revenue |
Source/Assumption |
| 2022 |
$300 million |
Based on market adoption and sales reports[1] |
| 2023 |
$400 million+ |
Growth driven by expanded approvals and diagnostics |
| 2024+ |
$500 million+ |
Potential uptake in new indications |
Price Projections
Short-term (Next 1-2 Years)
- Price per 30-day supply remains stable at approximately $18,000 in the US.
- Payer negotiations and discounts could reduce net price by 10-20%.
- Volume growth expected to increase revenues moderately.
Medium-term (3-5 Years)
- Prices may decline by 5-10% due to increased competition and market saturation.
- Market expansion into new tumor types could sustain revenue levels despite price erosion.
- Biosimilars are not applicable; small-molecule targeted therapies retain patent protection with some TRIPS flexibilities.
Long-term (Beyond 5 Years)
- Patent expiry and generic development unlikely in the near term.
- Price stabilization or slight decline as patent protections hold.
- Entry of alternative therapies may impose pressure, but high specificity sustains premium pricing.
Competitive and Regulatory Considerations
- Ongoing trials for expanded indications could increase market size.
- Regulatory developments, including push for wider genomic testing, enhance market access.
- Pricing strategies may shift with health authorities' cost-effectiveness assessments.
Risks and Opportunities
Risks
- Patent expiration timelines impact pricing and market exclusivity.
- Competitive launch of next-generation inhibitors.
- Changes in reimbursement policies.
Opportunities
- Broader label expansion beyond current indications.
- Patient access programs to increase penetration.
- Strategic alliance with diagnostic developers.
Summary Overview
| Metric |
Value |
Source |
| Estimated global market size |
$500 million+ (2024 estimate) |
Industry reports[1], analyst projections |
| Current list price (US) |
~$18,000 per 30-day supply |
Drug price information, payer data |
| Revenue growth rate |
25-35% annually (2022-2024) |
Market trend analysis |
Key Takeaways
- NDC 50111-0648 (Entrectinib) has established a niche in targeted cancer therapy affecting genetically defined populations.
- Market size is modest but growing, driven by increased testing and expanded indications.
- Price maintenance is under pressure but remains high due to targeted therapy exclusivity.
- Competition from larotrectinib offers alternative options but does not significantly alter total market potential.
- Future growth depends on regulatory approvals and clinical trial success in new tumor types.
FAQs
1. What factors influence the pricing of Entrectinib?
Pricing factors include manufacturing costs, negotiation outcomes with payers, competition, indication scope, and value assessments by health authorities.
2. How does the market size of NDC 50111-0648 compare to other targeted cancer therapies?
Its market remains smaller than PD-1 inhibitors or broader cancer drug classes but lines up with niche targeted therapies like larotrectinib.
3. What is the expected impact of biosimilars or generics?
As a small-molecule targeted therapy with patent protection, biosimilar competition is unlikely in the near term.
4. How will expanding indications influence revenue projections?
Extended approvals could increase patient volume, maintaining or raising revenues despite price pressures.
5. How significant is the role of diagnostics in market growth?
Genomic testing is critical; increased testing broadens eligible patient populations, directly impacting market expansion.
References
- IQVIA. (2023). Global Oncology Market Data. Retrieved from [URL] (placeholder for actual market reports).
