Last updated: February 25, 2026
What is the indication and pharmaceutical profile of NDC 00143-9140?
NDC 00143-9140 corresponds to Retevmo (selpercatinib), approved by the FDA in May 2020. It is a kinase inhibitor targeting RET (rearranged during transfection) alterations found in specific cancers, including non-small cell lung cancer (NSCLC), thyroid cancer (medullary and differentiated), and other RET fusion-positive tumors.
- Indications: NTRK fusion-positive solid tumors, RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer (MTC), RET fusion-positive thyroid cancer.
- Mechanism: Selectively inhibits RET kinase activity, disrupting tumor growth.
- Formulation: Oral capsules; 120 mg and 160 mg doses.
Market size and potential
Current market landscape
- Retreatment for RET-positive NSCLC: Estimated to reach annual sales of $500 million globally by 2025.
- Medullary Thyroid Cancer (MTC): Estimated to contribute around $200 million annually.
- Other RET-driven tumors: Contribute an additional $150-$200 million annually.
Key competitors
- Loxo-292 (Pralsetinib): Approved in September 2020, similar indication profile.
- Drives competition and caps prices.
- Molecular diagnostics: Increasing utilization influences market share by enabling targeted therapy.
- Generic competition: None currently for selpercatinib; patent expiration is not imminent before 2030.
Key market drivers
- Rising prevalence of RET alterations in oncology.
- Increasing adoption of personalized medicine.
- Growing number of diagnostic tests to identify RET fusions and mutations.
Market barriers
- High drug development and approval costs.
- Reimbursement challenges due to high drug prices.
- Limited patient population specificity restricts volume but maintains high per-unit price.
Price analysis and projections
Current pricing landscape
- Wholesale acquisition cost (WAC): Approximately $11,000 per month per patient (average wholesale price varies by setting).
- Average selling price (ASP): Slightly lower; approximately $10,500 per month.
- Annual treatment cost per patient: Approximately $126,000.
Historical price trends
- Post-FDA approval, initial pricing held steady with slight increases, aligned with specialty drug standards.
- Price stabilization is expected due to limited competition and high costs of targeted therapies.
Projected pricing trajectory (2023-2027)
| Year |
Estimated WAC per month |
Expected Price Trends |
Rationale |
| 2023 |
$11,000 |
Stable |
Current high-price maintenance, minimal competition |
| 2024 |
$11,000 - $11,500 |
Slight increase |
Price adjustments for inflation and market position |
| 2025 |
$11,500 - $12,000 |
Moderate increase |
Patent exclusivity sustains pricing power |
| 2026-2027 |
$12,000 - $12,500 |
Potential modest increase, or stabilization |
Market penetration plateau, generic entry unlikely before 2030 |
Revenue projections
Assuming:
- Market penetration rate: 8-12% of eligible RET-positive patients.
- Patient population: Estimated at 15,000 globally for RET-positive NSCLC and thyroid cancers.
- Annual patients treated: 1,200–1,800.
| Year |
Patients Treated |
Annual Revenue (USD) |
Notes |
| 2023 |
1,200 |
$151.2 million |
Base case, stable price |
| 2025 |
1,500 |
$207.0 million |
Increased adoption, rising prices |
| 2027 |
1,800 |
$270.0 million |
Peak market due to expanded indications |
Key market risks and considerations
- Patent expiry and biosimilars: No biosimilars expected before 2030; patent protection remains until at least 2028.
- Regulatory developments: Potential approvals for additional indications could expand market.
- Pricing pressures: Payer resistance could cap future price hikes.
- Competitive launches: Pralsetinib's market share may limit revenue growth.
Summary
NDC 00143-9140 (Retevmo) exhibits a stable high-price profile driven by specific indications, with annual revenues projected between $150 million and $270 million over the next five years, contingent on market penetration and pricing stability. Competition from Pralsetinib is a key factor in generating pricing constraints.
Key Takeaways
- Retevmo's market is constrained by small patient populations but supports high per-unit pricing.
- Competition from pralsetinib moderates future price increases.
- Revenue growth depends on expanding indications and diagnostic testing adoption.
- Patent protections delay generic entry until at least 2028.
- Market revenues are forecasted to grow modestly, reaching over $200 million annually by 2025.
FAQs
1. What factors could impact Retevmo's pricing in the coming years?
Pricing could be affected by payer negotiations, competition from pralsetinib, and adjustments in diagnostic testing reimbursement.
2. How does the approval of Pralsetinib influence Retevmo’s market share?
Pralsetinib provides an alternative therapy, likely reducing Retevmo's growth rate and forcing price competition.
3. Will broader indications increase Retevmo’s market size?
Yes, approval for additional tumor types with RET alterations could expand the patient pool and revenue potential.
4. What is the expected timeline for patent expiration?
Patent protections are expected to last until approximately 2028, delaying biosimilar entry.
5. How does diagnostic testing affect the Retevmo market?
Increased testing for RET alterations enables more accurate patient identification, supporting higher utilization rates.
References
[1] U.S. Food and Drug Administration. (2020). FDA approves first targeted therapy for metastatic RET fusion-positive non-small cell lung cancer. Retrieved from https://www.fda.gov
[2] EvaluatePharma. (2022). Oncology drug market report.
[3] IQVIA. (2022). Top Oncology Drugs by Revenue.
[4] Watson, M. (2022). Competitive landscape for RET inhibitors. Oncology Market Reports.
