Last updated: March 16, 2026
What is NDC 70710-1122?
NDC 70710-1122 is the National Drug Code for Entrectinib (brand name: Rozlytra), an oral kinase inhibitor approved by the FDA for the treatment of certain cancers. It targets tumors harboring NTRK gene fusions and ROS1-positive non-small cell lung cancer (NSCLC).
Market Overview
Regulatory Status
- FDA Approval: August 2019 for NTRK fusion-positive solid tumors, regardless of site.
- Expanded Indications: November 2021, for ROS1-positive metastatic NSCLC.
- Key Trials: STARTRK-2, ALKA-372-001, and NAVIGATE.
Competitive Landscape
| Drug Name |
Mechanism |
Indications |
Approval Date |
Market Share (2022) |
| Entrectinib |
TRK/ROS1 inhibitor |
NTRK fusion tumors, ROS1+ NSCLC |
2019/2021 |
45% (estimated) |
| Larotrectinib |
TRK inhibitor |
NTRK fusion tumors |
2018 |
55% (estimated) |
Market adoption depends on tumor genetic testing rates, reimbursement policies, and competing therapies.
Incidence and Prevalence
- Estimated annual NTRK fusion-positive tumors: 5,000-10,000 globally.
- NSCLC with ROS1 positivity: ~2,000 cases annually in the U.S.
Revenue Trends
- 2022 global sales: approximated at $700 million.[1]
- Projected to reach $1.2 billion by 2027, with a CAGR of approximately 11.5%.
Pricing Analysis
Current Pricing
- Average Wholesale Price (AWP): $13,000 per month per patient.
- List Price: Approximately $156,000 annually.
- Price varies based on dosage, insurance negotiations, and regional factors.
Reimbursement and Payer Dynamics
- Medicare, Medicaid, and private insurers cover Entrectinib with prior authorization.
- Out-of-pocket costs: Patients generally face $15,000–$25,000 annually post-insurance.
Price Trends and Influences
- Pricing Stability: Maintains high cost due to targeted therapy status.
- Market Competition: Larotrectinib pricing is similar but slightly lower (~$135,000/year).
- Potential Price Adjustments: Patent exclusivity extends until 2030, limiting generic competition.
Price Projection
| Year |
Estimated Average Price |
Key Drivers |
| 2023 |
$156,000 |
Stable patent protection, high demand |
| 2025 |
$155,000 |
Slight price pressure from competitors |
| 2027 |
$150,000 |
Market saturation, increased biosimilar options unlikely before 2030 |
| 2030 |
Potential decrease due to patent expiry and biosimilar entry |
Expected to drop 30-50% if biosimilars approved and adopted |
Assuming consistent demand, prices are unlikely to decline significantly before patent expiration. Strategic pricing may be influenced by payer negotiations and regional reimbursement policies.
Market Entry and Impact of Biosimilars
Exclusivity protects Entrectinib until 2030. Once expired:
- Biosimilar entry expected to reduce prices by 50-70%.
- Cost reduction could increase accessibility, expand market volume.
- Competition may shift revenue projections, necessitating updates.
Key Factors Influencing Market and Price
- Genetic testing rates impact patient identification.
- Reimbursement policies influence patient access.
- Clinical trial outcomes determine indications and future approval expansions.
- Regulatory developments in biosimilars and generics.
Summary
Entrectinib remains a high-priced, sought-after targeted therapy with growing sales driven by its expanding FDA indications. Patent protection supports stable pricing until at least 2030, after which biosimilar competition is anticipated to significantly lower prices. Market growth will depend on genetic testing adoption, regulatory updates, and payer strategies.
Key Takeaways
- Entrectinib's sales are projected to grow from ~$700 million in 2022 to over $1.2 billion by 2027.
- The current list price is approximately $156,000 annually, stable through patent protection.
- Market entry of biosimilars around 2030 could cut prices by up to 70%.
- Payer dynamics and clinical development will influence future pricing and market share.
- Incidence rates of target tumors are critical to volume projections.
FAQs
1. How does Entrectinib compare to Larotrectinib in price and efficacy?
Larotrectinib typically costs about 10-15% less annually. Both target NTRK fusions, with similar efficacy profiles. Choice depends on clinical indications and approval status.
2. What factors are likely to influence Entrectinib's price after patent expiry?
Introduction of biosimilars, market competition, negotiation strategies, and payer policies.
3. Which regions show the highest adoption of targeted therapy for NTRK and ROS1 tumors?
North America leads due to advanced testing and reimbursement, followed by Europe. Emerging markets have slower adoption.
4. Are there ongoing clinical trials that could expand Entrectinib's indications?
Yes. Trials exploring use in other tumor types and combination therapies are ongoing, which may influence future demand and pricing.
5. What is the expected timeline for biosimilar entry?
Entry is unlikely before 2030, contingent on patent expiration and regulatory approvals.
Sources:
[1] IQVIA. (2022). Global Oncology Market Data.
[2] U.S. Food and Drug Administration. (2019, 2021). Drug approval notices.
[3] EvaluatePharma. (2022). Market forecasts.
