Last updated: February 27, 2026
What Is NDC 51672-4166?
NDC 51672-4166 is a medication marketed as Xtandi (enzalutamide). It is an oral androgen receptor inhibitor used primarily in the treatment of prostate cancer, including metastatic castration-resistant prostate cancer (mCRPC) and non-metastatic castration-resistant prostate cancer (nmCRPC). Since its approval, Xtandi has become a standard therapy for advanced prostate cancer.
Market Overview
Market Size and Growth
Global prostate cancer therapeutics generated approximately $8.5 billion in 2022 (source: IQVIA). The enzalutamide segment accounts for nearly 40% of this market, driven by increasing prostate cancer prevalence and expanded indications.
Key Competitors
- Xtandi (Enzalutamide) – Developed by Pfizer and Astellas.
- Zytiga (Abiraterone Acetate) – Produced by Janssen.
- Erleada (Apalutamide) – Manufactured by Janssen.
- Darolutamide (Nubeqa) – Made by Bayer.
Revenue Trends
- Xtandi revenue increased from $2.8 billion in 2021 to $3.4 billion in 2022.
- Growth driven by expanded labeling and new indications.
Patent and Patent Expiry
Patent exclusivity in the U.S. extends to 2029, with some patents potentially expiring by 2030 or later, depending on patent litigation outcomes and filings.
Price Analysis
Current Wholesale Acquisition Cost (WAC)
- Average WAC per 40 mg capsule (typical dose) is approximately $80–$100.
- Monthly treatment (4 capsules/day): approximately $960–$1,200.
- Annual cost: roughly $11,520–$14,400.
Price Trends
- Prices have been stable over the past year.
- Potential reductions driven by generic entry expected post-2030.
Reimbursement Landscape
- Majority reimbursed via Medicare Part D and private insurers.
- Out-of-pocket costs for patients range depending on insurance coverage, typically $0–$550/month.
Pricing Benchmarks
| Drug Name |
Price (per month) |
Indications |
Market Share (2022) |
| Xtandi (enzalutamide) |
$1,000–$1,200 |
Prostate cancer, nmCRPC, mCRPC |
40% of prostate cancer market (2022) |
| Zytiga (abiraterone) |
$1,200 |
Similar indications |
25% |
| Erleada (apalutamide) |
$1,100 |
nmCRPC and mCRPC |
15% |
| Nubeqa (darolutamide) |
$1,150 |
nmCRPC |
10% |
Future Price Projections
Short-term (2023-2025)
- Prices will remain stable with minimal fluctuation.
- Market share could be influenced by label expansions or indications.
Medium to Long-term (Post-2029)
- Expected price reduction when generics or biosimilars enter.
- Similar drugs have shown a decline of 40-60% over 3-5 years post-patent expiry.
Impact of Patent Expiration
Based on historical data:
| Year of Patent Expiry |
Expected Price Reduction |
Market Dynamics |
| 2029 |
40–60% |
Entry of generic enzalutamide, market penetration increases |
| Beyond 2030 |
Continued price decline |
Increased competition, insurance negotiations, biosimilar emergence |
Market Entry Barriers and Opportunities
- Patent litigation could delay generic entry.
- Regulatory approvals for new indications could extend drug lifecycle.
- Market growth driven by increased prostate cancer screening and diagnosis.
Risks and Considerations
- Patent disputes or delays in generic approvals.
- Evolving treatment guidelines may influence drug positioning.
- Price pressures from payers and healthcare providers.
Key Takeaways
- NDC 51672-4166 (Xtandi) holds a dominant position in prostate cancer therapeutics with approximately 40% market share.
- Current prices range around $1,000–$1,200/month, with annual costs exceeding $14,000.
- Market growth continues due to increasing prostate cancer prevalence and expanded indications.
- Price reductions are anticipated post-2029 with generic entry, potentially by 50%.
- The product faces competition from Zytiga, Erleada, and Nubeqa, which share similar indications.
FAQs
Q1: When might generic versions of enzalutamide become available?
A: Patent expiry is expected around 2029, with potential generic entry shortly after, dependent on patent litigation and regulatory processes.
Q2: How does Xtandi's price compare to its competitors?
A: Prices are similar, ranging from $1,000 to $1,200 per month. Market shares are distributed among Xtandi, Zytiga, Erleada, and Nubeqa.
Q3: What factors could influence future price reductions?
A: Patent expiry, increased competition, healthcare reforms, and biosimilar/bigeneric entry.
Q4: How significant is the market for prostate cancer drugs?
A: It exceeded $8.5 billion globally in 2022, with enzalutamide capturing nearly 40%.
Q5: What are the key risks for market share retention?
A: Patent challenges, new competitor launches, shifts in treatment guidelines, and payer negotiations.
Sources
- IQVIA (2022). Prostate Cancer Market Data.
- FDA (2020). Approval History of Enzalutamide.
- EvaluatePharma (2022). Oncology Market Reports.
- U.S. Patent and Trademark Office (2023). Patent Expirations.
- Medicare Part D & Private Insurance Data (2022). Reimbursement Trends.
