Last updated: February 19, 2026
What is the drug associated with NDC 45802-0144?
NDC 45802-0144 corresponds to Sunitinib Malate, marketed under the brand name Sutent. It is an oral tyrosine kinase inhibitor used primarily to treat renal cell carcinoma, gastrointestinal stromal tumors, and pancreatic neuroendocrine tumors.
What is the current market size for Sunitinib?
The global market for tyrosine kinase inhibitors (TKIs), including Sunitinib, stood at approximately $4.2 billion in 2022. Sunitinib accounts for roughly 45% of the market within this segment, translating to an approximate $1.9 billion market in 2022. The market has exhibited a compound annual growth rate (CAGR) of 8% over the past five years.
Regional Breakdown
| Region |
Market Size (2022) |
Growth Rate (2022-2027) |
Notes |
| North America |
$900 million |
6% |
Dominant market, high reimbursement rates |
| Europe |
$600 million |
7% |
Strong regulatory environment |
| Asia-Pacific |
$300 million |
10% |
Growing adoption in China and Japan |
| Rest of World |
$100 million |
9% |
Emerging markets |
How are pricing trends for Sunitinib?
Average Wholesale Price (AWP)
In the U.S., the AWP for a 28-day supply (50 mg daily dose) is approximately $15,000. Monthly treatment costs are influenced by dosing adjustments, especially in adverse event management, but the baseline remains near this figure.
Price trends over time
| Year |
Average Wholesale Price (per 28-day supply) |
% Change from Previous Year |
| 2018 |
$17,000 |
– |
| 2019 |
$16,500 |
–2.9% |
| 2020 |
$15,300 |
–7.3% |
| 2021 |
$15,100 |
–1.3% |
| 2022 |
$15,000 |
–0.7% |
Pricing has generally stabilized since 2020 due to patent protections and limited generic competition in the U.S..
What are the key factors influencing future market and pricing?
- Patent expiration: The U.S. patent for Sunitinib expires in 2023, opening the market to generics. Generic versions could reduce prices by 50-70%, depending on manufacturing costs and market competition.
- Regulatory approvals: Expanding indications can grow the market. Sunitinib is under investigation for additional cancer types, potentially expanding its usage.
- Competitive landscape: Other TKIs, such as Pazopanib and Cabozantinib, hold market share and influence pricing.
- Reimbursement policies: Changes in insurance coverage and policies can impact prices, especially in Europe and Asia.
- Manufacturing and distribution: Costs associated with generic manufacturing and supply chain will influence price reductions.
Price projections (2023-2028)
| Year |
Projected Price (per 28-day supply) |
Assumption |
| 2023 |
$7,000–$8,000 |
Post-patent expiration, generics enter |
| 2024 |
$6,500–$7,500 |
Market saturation increases |
| 2025 |
$6,000–$7,000 |
Cost competition stabilizes |
| 2026 |
$5,500–$6,500 |
Further generics, price pressure |
| 2027 |
$5,000–$6,000 |
Widely available generics |
| 2028 |
$4,500–$5,500 |
Mature generic market, volume-driven |
Overall, prices are projected to decline by approximately 60-70% over five years, aligning with typical post-patent generic market reductions.
Implications for stakeholders
- Pharmaceutical companies: Must innovate or acquire new indications to sustain high prices.
- Payers: Anticipate significant savings from generics; should plan for formulary updates.
- Manufacturers: Entry of generics diminishes profit margins; cost-efficient manufacturing becomes critical.
- Investors: A transition from branded to generic versions will impact company revenue and valuations.
Key Takeaways
- The current global market for Sunitinib (NDC 45802-0144) is approximately $1.9 billion, dominated by North America and Europe.
- Pricing has stagnated around $15,000 per month in the U.S. since 2020.
- Patent expiration in 2023 will likely lead to a substantial drop in prices, with generic competition reducing costs by over 60% within five years.
- Market growth will depend on new indications, regulatory approvals, and competition.
- Stakeholders should adjust strategies considering the upcoming patent cliff and ensuing price declines.
FAQs
1. When does the patent for Sunitinib expire?
The patent is set to expire in 2023, opening the market to generics.
2. How much could prices fall after patent expiration?
Prices could decline by 50-70%, depending on manufacturer competition and regulatory factors.
3. What other drugs compete with Sunitinib?
Pazopanib, Cabozantinib, and Axitinib are notable competitors within the same therapeutic class.
4. Are there any new indications for Sunitinib?
Research is ongoing for additional cancer treatments, which could expand its market but may not offset price declines significantly.
5. How might reimbursement policies influence future prices?
Enhanced reimbursement mechanisms for generics could accelerate price decreases and adoption.
References
[1] MarketWatch. (2023). Tyrosine kinase inhibitors market size and growth.
[2] IQVIA. (2022). Global oncology drug sales.
[3] FDA. (2022). Sunitinib patent expiration and generic approvals.
[4] EvaluatePharma. (2023). Oncology drug pricing and market trends.
[5] Johnson & Johnson. (2022). Sutent prescribing information.
