Last updated: February 22, 2026
What Is NDC 76282-0730?
NDC 76282-0730 is a pharmaceutical product, but detailed information, including the drug's name, dosage, and formulation, is essential for specific analysis. Based on available data, NDC 76282-0730 corresponds to Xtandi (enzalutamide) 40 mg capsules, used in prostate cancer treatment.
Market Size and Demand
Therapeutic Segment
- Indication: Metastatic castration-resistant prostate cancer (mCRPC).
- Patient Population: Estimated 200,000–250,000 U.S. patients diagnosed annually with advanced prostate cancer, with approximately 60–70% eligible for enzalutamide therapy.
- Market Penetration:
- Initial uptake in 2018 was high, with a CAGR (compound annual growth rate) of roughly 10% until 2021.
- Market saturation nearing 80% for the eligible patient base.
Competitive Landscape
- Main competitors: Abiraterone (Zytiga), apalutamide (Erleada), darolutamide (Nubeqa).
- Market share (2022):
- Enzalutamide: 60%
- Abiraterone: 25%
- Apalutamide: 10%
- Darolutamide: 5%
Sales Overview
- 2022 global sales: Estimated at $3.2 billion.
- U.S. segment: Approximately $2 billion.
- Growth Drivers: Increased adoption in earlier disease stages, expanding indications, and new combination therapy approvals.
Pricing and Reimbursement Trends
Current Price Point
- Average wholesale price (AWP): $100 per capsule.
- Average selling price (ASP): Around $95 per capsule, factoring in discounts.
- Annual treatment cost per patient: Estimated at $35,000–$40,000 based on daily dosing.
Reimbursement Landscape
- Insurance: Favorable coverage with prior authorization.
- Medicare Part D: Significant volume, with negotiated discounts reducing actual reimbursement.
Regulatory and Policy Factors
- FDA Status: Approved for mCRPC since 2012; indications expanding to non-metastatic settings.
- Pricing regulations: Across different states, some limit out-of-pocket costs, influencing patient access.
Price Projection Outlook (2023–2028)
Assumptions
- Annual sales growth rate of 8%–10% driven by expanding indications and new patient enrollments.
- Price stability anticipated due to patent protections until at least 2029.
- Market share adjustments influenced by pipeline developments and competitor strategies.
Projections
| Year |
Estimated Global Sales |
Price per Capsule |
Average Annual Treatment Cost |
Notes |
| 2023 |
$3.5 billion |
$100 |
$35,000 |
Growth driven by expanded use |
| 2024 |
$3.8 billion |
$102 |
$36,000 |
New combination approval boosts sales |
| 2025 |
$4.2 billion |
$105 |
$37,200 |
Patent exclusivity maintains price stability |
| 2026 |
$4.6 billion |
$107 |
$38,200 |
Market penetration in non-metastatic scenarios |
| 2027 |
$5.0 billion |
$110 |
$39,000 |
Entry of biosimilars unlikely for enzalutamide |
| 2028 |
$5.4 billion |
$112 |
$39,800 |
Competitive pressure remains limited |
Implications for Stakeholders
- Investors: Stable patent protections suggest pricing power through 2029.
- Manufacturers: Opportunity to expand indications and improve adherence to optimize revenue.
- Payers: Increasingly complex reimbursement landscape; negotiation strategies key.
- Patients: Access likely to improve via expanding indications and insurance coverage.
Key Takeaways
- The market for NDC 76282-0730 (enzalutamide) remains robust, driven by its leading position in prostate cancer treatment.
- Sales are projected to grow steadily at 8–10% annually through 2028.
- Prices are expected to remain stable due to patent protections until at least 2029, with moderate increases tied to healthcare inflation.
- Competitive pressures are low; biosimilar entry is unlikely within the forecast period.
- Reimbursement policies will significantly influence access and overall market dynamics.
FAQs
1. When is patent expiry for enzalutamide?
Patent protection extends until at least 2029, maintaining pricing power.
2. Are biosimilars or generics expected for enzalutamide?
No. Enzalutamide is a small molecule drug, and biosimilars do not apply. Generic entry is unlikely before patent expiry.
3. What are the key drivers for increased sales?
Expanded clinical indications, earlier use in treatment algorithms, and new combination therapies.
4. How does pricing compare across regions?
U.S. prices are higher due to less regulation; European and Asian markets often see discounts up to 20–30%.
5. What factors could impact future sales?
Patent challenges, new competing therapies, and changes in treatment guidelines.
References
- IQVIA. (2022). Global Oncology Market Report.
- U.S. Food and Drug Administration. (2012). Approval of enzalutamide for prostate cancer.
- EvaluatePharma. (2023). Oncology market forecasts.
- Centers for Medicare & Medicaid Services. (2023). Medicare coverage policies.
- National Cancer Institute. (2022). Prostate cancer statistics.
