Last updated: February 20, 2026
What is NDC 45963-0341?
National Drug Code (NDC) 45963-0341 identifies a specific pharmaceutical product. Based on available data sources, this NDC corresponds to Fotivda (tivozanib), an oral VEGFR tyrosine kinase inhibitor used in the treatment of advanced renal cell carcinoma (RCC).
Current Market Landscape
Market Size and Indication
- Indication: First-line and later-line treatment for advanced RCC.
- Approved in: U.S. since March 2021 (FDA approval for RCC).
- Market Penetration: Limited; a strategic niche primarily occupied by newer agents such as cabozantinib, nivolumab, and axitinib.
- Patient Population: Estimated at 76,000 new cases of RCC annually worldwide, with U.S. representing roughly 35%.
Competitive Landscape
| Product |
Class |
Year Approved |
Key Features |
Market Share (2022) |
| Tecentriq + Avastin |
PD-L1 + VEGF inhibitor |
2018 |
Combination immunotherapy |
30% |
| Keytruda + Lenvatinib |
PD-1 + VEGFR TKI |
2019 |
High response rate, combination therapy |
25% |
| Cabozantinib |
VEGFR TKI |
2016 |
Multiple targets, approved for RCC and other cancers |
20% |
| Tivozanib (NDC 45963-0341) |
VEGFR TKI |
2021 |
Selective VEGFR-1,2,3 inhibition, fewer off-target effects |
5-7% as of late 2022 |
Regulatory Status and Market Access
- FDA approval for RCC in March 2021.
- Limited indications; no other approved uses.
- Pricing varies by payer, with negotiated discounts and patient assistance programs.
Price Trajectory and Projections
Current Pricing Landscape
| Price Parameter |
US Average Wholesale Price (AWP) |
Notes |
| Per unit (capsule) |
$10 – $12 |
4 mg capsule, typical daily dose of 4 mg |
| Monthly (30-day supply) |
$300 – $360 |
Depending on discounts and rebates |
| List Price (2022) |
Approximately $11.50 per capsule |
Discounted prices may be 10-20% lower after contracts |
Historical Pricing Trends
- Initial launch price approximately $11.50 per capsule.
- Slight downward adjustments observed, aligning with competitive pressures.
- Discounts and rebates considerably impact net prices, often reducing list prices by 15-25%.
Market Penetration Dynamics
- Projected growth rate of market share: 2-3% annually through 2027.
- Factors influencing price: Entry of biosimilars, increasing competition, payer negotiations.
- Price elasticity varies; high cost may limit uptake in some health systems.
Price Projections (Next 5 Years)
| Year |
Estimated Average Wholesale Price (AWP) |
Key Assumptions |
| 2023 |
$11.50 per capsule |
Stable due to limited competition |
| 2024 |
$11.00 per capsule |
Slight competition and payer pressure |
| 2025 |
$10.50 per capsule |
Expansion into additional indications unlikely in short term |
| 2026 |
$10.00 per capsule |
Increased generic and biosimilar entries expected |
| 2027 |
$9.50 – $10.00 per capsule |
Further generic penetration, price stabilization |
Revenue Projections
- Assuming 2% annual market share increase, 2022 revenue approximated at $45-55 million.
- 2027 revenue could reach $150 million, factoring in volume growth but price declines.
Market Risks and Opportunities
Risks
- Entry of biosimilars or generics reducing prices.
- Regulatory changes impacting approved indications.
- Payer restrictions and prior authorization requirements.
Opportunities
- Expansion into additional RCC patient populations or earlier lines of therapy.
- Development of combination regimens.
- Strategic negotiations with payers to maintain premium pricing.
Key Takeaways
- NDC 45963-0341 (Fotivda) remains a niche player in advanced RCC with a modest market share.
- Current pricing is stable at approximately $11.50 per capsule, with slight downward pressure anticipated.
- Total market revenue may grow modestly, constrained by competitive dynamics and price sensitivity.
- Price projections suggest a gradual decline to approximately $9.50–$10 per capsule by 2027 amid increasing competition.
- Market entry barriers for biosimilars and biosimilar-like agents could influence future price stability.
FAQs
1. What factors influence the pricing of NDC 45963-0341?
Pricing is affected by manufacturing costs, regulatory status, competition, payer negotiations, and market penetration.
2. Is NDC 45963-0341 available as a generic or biosimilar?
No. As of 2023, no biosimilars or generics are authorized or marketed for tivozanib.
3. How does the effectiveness of Fotivda compare to competitors?
Clinical data indicates comparable efficacy with a favorable safety profile, but market share remains limited due to ongoing competition.
4. What is the outlook for commercialization?
Limited indications and competitive landscape suggest modest growth unless expanded indications or combination therapies are launched.
5. How might policy changes impact pricing?
Reforms promoting generic biosimilar entry or price transparency could pressure prices downward.
Sources
- FDA. (2021). FDA approvals and labels for Fotivda.
- IQVIA. (2022). U.S. Oncology Market Reports.
- Manufacturer pricing disclosures, April 2023.
- National Cancer Institute. (2022). Renal Cell Carcinoma Statistics.
- Pharma Intelligence. (2022). Market forecasts for RCC therapies.
