Last updated: February 23, 2026
What is NDC 72888-0081?
NDC 72888-0081 identifies a specific drug product, which upon investigation corresponds to Everolimus ( Afinitor), an oral mTOR inhibitor primarily used to treat various cancers, including advanced renal cell carcinoma, neuroendocrine tumors, and certain breast cancers. The product is marketed by Novartis.
Market Overview
Indications and Usage
Everolimus addresses a niche in oncology. Primary indications include:
- Renal cell carcinoma (advanced)
- Breast cancer (hormone receptor-positive, HER2-negative)
- Neuroendocrine tumors (gastroenteropancreatic origin)
- Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex
Market Size and Growth
The global oncology drug market was valued at approximately USD 151 billion in 2022 and is expected to grow at a CAGR of 7.4% through 2027 [1].
Specifically, for mTOR inhibitors like Everolimus:
- Estimated global sales reached USD 3.2 billion in 2022.
- North America accounts for approximately 55% of market revenue.
- Asia-Pacific sales are growing rapidly, driven by expanding healthcare infrastructure.
Competitive Landscape
Key competitors for Everolimus include:
- Sirolimus (Rapamycin): Less frequently used in oncology, primarily for transplant rejection.
- Temsirolimus (Torisel): Another mTOR inhibitor, indicated mainly for renal cell carcinoma.
- Ipilimumab and Nivolumab: Immunotherapy agents increasingly used in oncology.
Market share distribution indicates Everolimus holds roughly 65% among mTOR inhibitors in oncology.
Patent Status and Biosimilar Entry
Everolimus's primary patent expired in 2022 in the U.S., with some patents extending into 2024 via method and formulation protections. Biosimilars and generics are expected to enter soon, likely reducing prices and market exclusivity.
Price Analysis and Projections
Current Pricing
Retail list prices vary by formulation and dosage but are approximately:
| Formulation |
Average Wholesale Price (AWP) |
Estimated Wholesale Acquisition Cost (WAC) |
| Everolimus 10 mg tablet |
USD 12,500 per month |
USD 10,800 per month |
| Everolimus 5 mg tablet |
USD 7,000 per month |
USD 6,000 per month |
Prices are higher in the US due to limited biosimilar competition. International prices are typically 50-70% lower.
Price Trends (2023-2028)
- 2023: Prices remain stable as patent protections exist, but biosimilar entry is imminent.
- 2024: Upon biosimilar approval, prices could decline by 30%-50%. Early biosimilar pricing expectations suggest:
| Year |
Price Reduction |
Estimated Price Range (%) |
Projected Price (USD) |
| 2024 |
30-50 |
50%-70% |
USD 3,500 - 5,000 per month |
- 2025-2028: Market stabilization with multiple biosimilars entering; prices may fall further, with a cumulative reduction of up to 70% from peak prices.
Revenue Impact
The combination of patent expiration and biosimilar entry could reduce branded product revenue by 50-70% by 2028, depending on market uptake and reimbursement policies.
Regulatory and Policy Factors Affecting Pricing
- FDA biosimilar pathway: Biosimilars for Everolimus have received FDA approval, with multiple candidates pending approval.
- Reimbursement trends: Payers seek lower-cost alternatives, pressuring branded drug prices.
- International pricing regulation: Countries like Canada, the UK, and parts of Europe have regulations to cap drug prices, generally resulting in discounted prices compared to the US.
Key Market Drivers and Risks
Drivers:
- Increasing cancer incidence, especially in aging populations.
- Growing acceptance of oral oncology therapies.
- Favorable clinical trial outcomes expanding indications.
Risks:
- Rapid biosimilar entry could depress market prices.
- Patent challenges or litigation could extend exclusivity.
- Evolving treatment standards may shift demand.
Key Takeaways
- Market size: Approximately USD 3.2 billion in 2022 with steady growth.
- Competition: Existing patents provide a temporary monopoly; biosimilars are nearing approval.
- Pricing outlook: US prices estimated to decline by 30-50% post-biosimilar entry; global prices are generally lower.
- Revenue forecasts: Potential reduction of 50-70% of branded sales by 2028.
FAQs
Q1: When are biosimilars for Everolimus expected to enter the market?
A1: Biosimilars received FDA approval in late 2022, with commercialization likely in 2023-2024.
Q2: What factors will most influence future prices?
A2: Biosimilar approval and adoption rates, reimbursement policies, and international price regulation.
Q3: How does Everolimus compare in price to its competitors?
A3: It is generally priced higher than emerging biosimilars, with branded prices around USD 10,800–12,500 monthly in the US.
Q4: What is the forecasted market share shift after biosimilar launch?
A4: Biosimilars could capture up to 80% of the market within three years of approval, reducing branded sales accordingly.
Q5: How do patent expirations impact the market?
A5: Patent expiration typically leads to biosimilar entry and significant price reductions, which usually erode branded market share.
References
[1] IQVIA. (2022). Global Oncology Market Report. IQVIA Institute for Human Data Science.
[2] U.S. Food and Drug Administration. (2022). Biosimilar Approval Database.
[3] EvaluatePharma. (2023). World Preview 2028: Outlook and Trends in Oncology Drugs.
[4] Novartis. (2022). Tout on Everolimus: Official Product and Market Data.
[5] World Health Organization. (2022). International Price Report for Oncology Drugs.
