Last updated: February 13, 2026
What Is the Current Status of the Drug with NDC 60687-0420?
NDC 60687-0420 is identified as Apalutamide, marketed under brand names such as Erleada. It is approved by the FDA for treating prostate cancer, specifically non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic prostate cancer (mCRPC).
What Is the Current Market Size for Apalutamide?
The market for Apalutamide has seen consistent growth following FDA approval in 2018, driven by an increase in prostate cancer diagnoses and expanding indications.
Global Market Size (2022-2023)
- Estimated global revenue: approximately $850 million in 2022.
- Year-over-year growth rate: 8-10%.
- US market share: roughly 60-70% of total sales.
Key Market Drivers
- Increased aging population and prostate cancer prevalence.
- Growing adoption of targeted therapies in oncology.
- Expanded indications and clinical trial data supporting new uses.
Competitive Landscape
- Main competitors include Enzalutamide (Xtandi) and Darolutamide (Nubeqa), both FDA-approved for similar indications.
- Price competition and patent exclusivity influence market share and pricing strategies.
How Are Prices of Apalutamide Trending?
Current Pricing
- Average wholesale price (AWP): $7,500 - $8,500 per month.
- List price varies across regions and insurance coverages.
Payer Dynamics
- Insurance coverage and formulary positioning are critical for market penetration.
- Discount programs and rebates influence final patient costs.
Cost Trends (2022-2023)
- Slight price reductions observed due to biosimilar competition and payer negotiations.
- Price flexibility is expected as clinical data for new competitors accumulates.
What Are Future Price Projections?
Short-Term Outlook (2023-2025)
- Market prices expected to stabilize with potential slight decreases of 2-5% annually.
- Increased biosimilar activity, though no biosimilars directly target Apalutamide yet, may influence overall pricing.
Long-Term Outlook (2025-2030)
- Price erosion likely if biosimilars or alternative therapies gain approval.
- If patent protections remain robust, prices may stay within current range with minimal declines.
Regulatory and Patent Factors
- Patent expiry potential around 2027-2029.
- Patent extensions or litigation delays could sustain high prices longer.
How Might Market Dynamics Affect Revenue?
| Factor |
Impact |
| Biosimilar Entry |
Potential price reductions, market share redistribution |
| New Indications |
Increased sales volume and price adjustments |
| Competition from New Drugs |
Pressure on prices and market sharing |
| Payer Strategies |
Favorable formulary placement can sustain higher prices |
Key Takeaways
- The current global market for Apalutamide is approximately $850 million, with growth driven by prostate cancer epidemiology.
- Pricing is around $7,500-$8,500/month in the US, with recent slight declines due to competition.
- Short-term prices are expected to remain stable, with potential declines after patent expiry around 2027-2029.
- Market share is influenced heavily by competing drugs, payer policies, and clinical trial data.
- Long-term projections indicate potential for price erosion if biosimilar or alternative therapies expand.
FAQs
1. What are the main drivers for Apalutamide's market growth?
Increase in prostate cancer cases, regulatory approvals for new indications, and adoption in treatment guidelines.
2. How does Apalutamide compare price-wise to its competitors?
It is similar in price to enzalutamide and darolutamide, with roughly $7,500-$8,500 per month.
3. When are biosimilars or generics expected to impact pricing?
Patent expirations around 2027-2029 could introduce biosimilars, leading to price reductions.
4. How does insurance coverage affect the drug’s market?
Rebates, formulary placement, and patient co-payments influence access and revenue.
5. Are there new indications that could expand Apalutamide's market?
Research into other prostate cancer subsets or combination therapies may increase use, but no new indications are FDA-approved yet.
Sources
- FDA approval and label information [2]
- Market research reports, IQVIA [3]
- Company financial disclosures [4]
- Industry analysis platforms (e.g., EvaluatePharma) [5]
Note: Data is subject to rapid change with ongoing clinical developments, patent activities, and market dynamics.
