Last updated: February 20, 2026
What is NDC 59651-0573?
NDC 59651-0573 refers to a specific medication product. Based on available public records, this NDC corresponds to Enzalutamide (oral) 40 mg. Enzalutamide is an androgen receptor inhibitor approved for treating prostate cancer, notably castration-resistant prostate cancer (CRPC).
Market Overview
Market Size and Demand
- The global prostate cancer therapeutics market was valued at approximately $8.5 billion in 2022.
- Enzalutamide held a dominant share, with an estimated revenue of $4.2 billion in 2022, driven by its coverage across multiple indications: metastatic CRPC, non-metastatic CRPC, and as part of combination regimens.
- The drug finds extensive use in the U.S., where roughly 174,000 new prostate cancer cases are diagnosed yearly (SEER Program, 2022).
Competitive Landscape
| Key Competitors |
Market Share (2022) |
Notable Drugs |
| Johnson & Johnson |
35% |
Darolutamide (Nubeqa) |
| Pfizer |
25% |
Apalutamide (Erleada) |
| Astellas Pharma |
15% |
Enzalutamide (Xtandi) |
| Others |
25% |
Various generics and biosimilars |
- Enzalutamide leads the market, with several competitive drugs expanding options for prostate cancer management. Patent expirations are anticipated in 2029, paving the way for generics.
Regulatory and Patent Status
- Patent protection for Xtandi (generic name for Enzalutamide) expires in the US in December 2029.
- The drug received FDA approval in August 2012 for metastatic CRPC, with subsequent approvals expanding its indications.
Reimbursement Environment
- Insurance coverage is extensive in the U.S., with Medicare and private insurers covering the drug.
Price Trends and Projections
Current Pricing
| Formulation |
Average Wholesale Price (AWP) |
Estimated Patient Cost (U.S.) |
| Enzalutamide 40 mg tab |
~$60 per tablet |
~$2,400 for a 30-day supply |
- Commercial insurance often lowers out-of-pocket costs; government programs like Medicare negotiate prices.
Market Pricing Dynamics
- Listed prices have increased approximately 6%-8% annually over the past five years, aligning with inflation and R&D amortization.
- The impending patent expiration in 2029 is expected to trigger a reduction in branded prices as generics enter the market, potentially decreasing list prices by 60%-70% within the first two years post-generic entry.
Price Projections (2023-2030)
| Year |
Brand Price (U.S.) |
Estimated Generic Price (Post-2029) |
Changes from Previous Year |
| 2023 |
~$2,400 |
N/A |
Stable; driven by demand and inflation |
| 2024 |
~$2,500 |
N/A |
Slight increase; patent protections continue |
| 2027 |
~$2,700 |
N/A |
Pre-generic phase; increased stockpiling |
| 2029 |
~$2,500 |
~$900–$1,200 |
Price reduction expected as generics enter |
| 2030 |
~$2,300 |
~$500–$750 |
Market saturation; generic dominance |
Factors Influencing Price Trends
- Patent expiration in 2029 prompts potential pricing declines.
- Entry of biosimilars and biosimilar competitors could further influence prices.
- Market dynamics, including manufacturing costs, regulatory policies, and payer negotiations, will impact prices.
Key Market Drivers
- Growing prostate cancer prevalence and aging populations.
- Expanded indications for enzalutamide use.
- Patent expiry and generic competition.
- Cost-containment policies by healthcare systems.
Risks and Barriers
- Delays in patent litigation or patent extensions.
- Slow adoption of generics due to market hesitancy.
- Changes in reimbursement policies for high-cost drugs.
Final Remarks
Three key phases will influence the pricing trajectory: current stabilization, pre-generic market saturation, and post-generic entry. Price reductions are expected after patent expiry, with the most significant decline occurring within the first two years following generic launch.
Key Takeaways
- NDC 59651-0573 (Enzalutamide 40 mg) is a leading prostate cancer treatment with a market share of around 35%.
- The drug generated approximately $4.2 billion in revenue in 2022 within the global market.
- Current U.S. list prices average $2,400 per month, with stable growth until patent expiration.
- Generic competition expected in 2029 will likely reduce prices by up to 70%.
- Market growth is driven by rising prostate cancer prevalence, but pricing is sensitive to patent status, reimbursement policies, and competitive dynamics.
FAQs
1. When will generic versions of Enzalutamide become available?
Patent expiry in the U.S. is set for December 2029, after which generics are expected to enter the market.
2. How will patent expiry impact prices?
Prices could decline by approximately 60%-70% within two years of generic entry, depending on market competition and payer negotiations.
3. What are the primary indications for NDC 59651-0573?
It is approved for metastatic castration-resistant prostate cancer, non-metastatic CRPC, and as part of combination therapy.
4. What is the current market share of enzalutamide relative to competitors?
Enzalutamide has roughly 35% market share, competing primarily against darolutamide and apalutamide.
5. Are there biosimilar or biosimilar-like products under development?
Bioequivalent generics are anticipated post-2029; biosimilar development does not apply as enzalutamide is small-molecule, not biologic.
References
- SEER Program. (2022). Cancer statistics. National Cancer Institute.
- FDA. (2012). Enzalutamide approval documentation. U.S. Food & Drug Administration.
- IQVIA. (2022). Global Oncology Market Report.
- DrugPatentWatch. (2023). Enzalutamide patent expiry analysis.
- Centers for Medicare & Medicaid Services. (2023). Drug pricing and reimbursement policies.
