Last updated: February 23, 2026
What is NDC 16729-0331?
NDC 16729-0331 is the National Drug Code for Everolimus, marketed under the brand name Afinitor. It is an oral mTOR inhibitor used to treat various cancers, including advanced kidney cancer, breast cancer, and neuroendocrine tumors, along with certain tuberous sclerosis complex-associated tumors.
Current Market Landscape
Sales and Usage Trends
- Market Size (2022): The global Everolimus market was valued approximately at $1.2 billion. Sales are projected to grow at a compound annual growth rate (CAGR) of around 8% through 2027.
- Major Markets: United States, European Union, Japan, and China.
- Revenue Distribution: The US accounts for roughly 50% of sales, driven by high prevalence of indicated cancers and access to healthcare.
- Patient Access: Increased approvals for new indications and expanded line-of-therapy use drive demand.
Key Competitors
- Everolimus (Afinitor): Market leader with brand and generic versions.
- Other mTOR inhibitors: Temsirolimus, Ridaforolimus (less prominent).
- Emerging competitors: Next-generation mTOR inhibitors and targeted therapies for similar indications.
Regulatory Status
- FDA Approval: For multiple indications, including breast cancer (2012), renal cell carcinoma (2009), neuroendocrine tumors (2011), and tuberous sclerosis complex (2012).
- EU: Approved for similar indications, enhancing market potential in Europe.
Price Analysis
Current Pricing (2023)
| Price Component |
Price Range |
Notes |
| Brand name (Afinitor) |
$10,500 – $14,000 per month |
Average wholesale price (AWP) for 10 mg tablets. |
| Generic version |
$2,500 – $4,500 per month |
Available since patent expiration in 2015. |
| Per-unit cost |
$200 – $1,400 per tablet |
Based on dose and market. |
Pricing Dynamics
- Brand vs. Generic: Generic versions have reduced prices by approximately 60-75% compared to brand.
- Market penetration of generics: Over 60% of sales now come from generics due to patent expiry.
- Pricing trends: The brand remains priced higher due to brand recognition and patent protection, with price erosion slowing as newer indications are added.
Price Projections (2023-2027)
| Year |
Estimated Average Cost (Monthly) |
Factors Influencing Price |
| 2023 |
$10,500 – $14,000 (brand) |
Patent protection, inflation, launch of generics |
| 2024 |
$8,500 – $12,000 (mix of brand and generic) |
Increased market share for generics, price competition |
| 2025 |
$6,500 – $10,000 |
Possible patent challenges, biosimilar development |
| 2026 |
$5,000 – $8,500 |
Expanded indications, biosimilar entry |
| 2027 |
$4,000 – $7,000 |
Patent expiry impact, new competitors |
Market Drivers and Risks
Drivers
- Expanded indications: Ongoing trials and approvals for additional cancer types.
- Increased screening: Higher detection rates for targeted cancers.
- Healthcare infrastructure: Greater access in emerging markets.
Risks
- Patent expiration: Accelerates generic entry, reducing prices.
- Regulatory hurdles: Delays in approval for new indications could slow revenue growth.
- Market saturation: Competing therapies could limit growth potential.
Key Takeaways
- NDC 16729-0331 (Everolimus/Afinitor) maintains significant market share, supported by broad indications.
- The price of brand-name drug remains high but is declining with generic entry; overall market prices are expected to decrease over the next four years.
- Market growth is driven by new indications and increased screening but faces risks from patent expiry and competition.
- Price projections suggest a steady decline in monthly costs, aligning with generic penetration and biosimilar development.
FAQs
1. What factors influence Everolimus pricing?
Patent status, competition from generics, approval of new indications, and market demand.
2. How does patent expiration impact prices?
Patent expiration typically leads to biosimilar or generic versions, reducing prices by 60-75%.
3. Are there upcoming approvals that could influence market size?
Yes, ongoing clinical trials for new cancer indications could expand the market.
4. How does market penetration differ between regions?
The US leads in market penetration, with evolving markets in Europe and Asia gaining share through expanding approvals.
5. What is the outlook for biosimilars?
Biosimilar development is progressing, with several candidates in late-stage trials, which could further decrease prices.
References
- IQVIA. (2022). Pharmaceutical Market and Price Trends.
- U.S. Food and Drug Administration. (2022). Drug approvals and indications.
- Evaluate Pharma. (2023). World Preview 2027: Market Trends and Forecasts.
- GlobalData. (2023). Cancer Therapy Market Reports.
- U.S. Patent and Trademark Office. (2022). Patent Status for Everolimus.
