Last updated: February 23, 2026
What is the drug represented by NDC 31722-0049?
NDC 31722-0049 is a prescription medication marketed under the brand name Inlyta (axitinib), developed by Pfizer. It is a tyrosine kinase inhibitor used primarily in the treatment of advanced renal cell carcinoma (RCC).
What is the current market size for Inlyta?
Sales Overview (2022-2023)
| Year |
Global Sales (USD millions) |
US Sales (USD millions) |
Market Share in RCC (US) |
Competitor Market Share |
| 2022 |
950 |
600 |
10% |
Sutent (17%), Cabometyx (12%) |
| 2023* |
1,020* |
650* |
11% |
Sutent (15%), Cabometyx (13%) |
*Estimates based on IQVIA and company reports.
Market Size Drivers:
- Incidence of metastatic RCC: approximately 76,000 new cases globally annually.
- Approved indications: first-line therapy for advanced RCC.
- Competitive landscape: dominated by drugs like cabozantinib, sunitinib, and pazopanib.
What are the key competitors?
| Drug Name |
MoA |
Market Share (2023) |
Price (USD per treatment cycle) |
Approved Indications |
| Sutent |
Sunitinib (Multi-kinase inhibitor) |
15% |
11,500 |
RCC, neuroendocrine tumors |
| Cabometyx |
Cabozantinib (Tyrosine kinase inhibitor) |
13% |
12,000 |
RCC, hepatocellular carcinoma |
| Inlyta |
Axitinib (Tyrosine kinase inhibitor) |
11% |
11,750 |
RCC |
How do pricing and reimbursement impact market access?
- List price for Inlyta: approximately $11,750 per cycle (28 days).
- Reimbursement largely relies on Medicare, Medicaid, private insurers.
- Price negotiations and value-based agreements are emerging, especially in large U.S. commercial markets.
- Prices for competitors vary within a similar range, maintaining a competitive landscape.
What are the factors influencing future price projections?
Patent Status and Off-Patent Risks
- Patent protection: patent expiry expected around 2026.
- Patent challenges or generic launches projected for 2025-2026, which could reduce prices by 30-50%.
Market Entry and Competition
- Biosimilars or generics entering post-2026 could decrease prices.
- Continued clinical development of combination therapies may impact pricing strategies.
Regulatory and Policy Trends
- Price regulation efforts are increasing globally.
- In the U.S., value-based pricing and Medicare negotiation initiatives could pressure prices downward.
R&D and Pipeline Potential
- Pfizer's pipeline includes combination therapies and new indications.
- Successful expansion could sustain or elevate pricing for new indications.
What are the price projection scenarios?
| Scenario |
Timeframe |
Price Estimate (USD per cycle) |
Assumptions |
| Conservative |
2024-2026 |
$11,500-$11,750 |
Stable market share, patent protection intact, slow competition |
| Moderate |
2024-2026 |
$10,000-$11,000 |
Early generic entry, price negotiations, shifts in payer policies |
| Optimistic |
2027+ |
$9,000-$10,500 |
Increased competition, biosimilar entry, expanded indications |
Summary of Key Data Points
- Global RCC treatment market valued at approximately USD 2.8 billion in 2022.
- Inlyta accounts for roughly 11% of this market.
- Current treatment cycle costs hover around USD 11,750.
- Patent expiry near 2026 poses significant risk of price erosion.
- Competition and policy shifts likely to drive prices downward post-2026.
Key Takeaways
- Inlyta holds a moderate market position in RCC but faces near-term patent expiration.
- Pricing remains stable for now but could decrease by approximately 20-30% upon patent expiry.
- Competition from generics and biosimilars will accelerate price declines.
- Expansion into combination therapies may sustain revenues, but pricing flexibility will be constrained by policy pressures.
- Industry shifts towards value-based models likely will influence future pricing strategies.
FAQs
1. When does the patent for Inlyta expire?
Expected patent expiry is around 2026, which could lead to generic competition.
2. Will generic versions of axitinib enter the market?
Yes, generic versions are expected to launch following patent expiration, potentially reducing prices significantly.
3. How does Inlyta compare price-wise with competitors?
Inlyta's list price is comparable to sunitinib and cabozantinib, within a range of USD 11,500–12,000 per cycle.
4. What factors could stabilize prices beyond 2026?
Limited competition, new approved indications, and potential value-based pricing agreements may help preserve revenue levels.
5. What is the treatment cost impact on healthcare budgets?
Treatment costs contribute significantly to RCC management expenses, with annual costs per patient around USD 140,000–150,000, emphasizing the importance of pricing strategies and access policies.
References
[1] IQVIA. (2023). Pharmaceutical Market Reports.
[2] Pfizer. (2023). Inlyta Product Label.
[3] FDA. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
[4] Evaluate Pharma. (2023). World Preview: Outlook to 2028.
