Last updated: February 23, 2026
What is NDC 00904-6939?
NDC 00904-6939 is a drug identified in the National Drug Code (NDC) database. According to available data, it corresponds to Zytiga (abiraterone acetate) 250 mg tablets, used primarily for prostate cancer treatment.
Market Overview
Indications and Patient Population
Zytiga (abiraterone acetate) is indicated for:
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer with high risk of metastasis
The global prostate cancer market approaches over $7 billion in 2022, with an expected compound annual growth rate (CAGR) of approximately 4% through 2028 (Fortune Business Insights, 2022).
Competitive Landscape
Key competitors include:
- Merck's Xtandi (enzalutamide)
- Johnson & Johnson's Erleada (apalutamide)
- Bayer's Nubeqa (darolutamide)
Market fragmentation indicates Zytiga holds roughly a 30–35% share in the prostate cancer therapy market, positioning it as a significant player but not dominant.
Sales Trends
Global sales of Zytiga peaked at approximately $950 million in 2021. Post-expiry of patent protections in some regions, generic versions entered the market, impacting branded sales:
| Year |
Global Sales (Million USD) |
Notes |
| 2018 |
1,050 |
Peak before patent expiry |
| 2019 |
1,000 |
Patent expiry begins, generics introduced |
| 2020 |
950 |
Generics gain market share |
| 2021 |
950 |
Stable, with increased generic competition |
Growth projections suggest continued erosion of branded sales, with generics expected to account for 50-60% of market share in major regions by 2024.
Price Analysis
Brand vs. Generic Pricing
| Market Region |
Branded Price (per 250 mg tablet) |
Generic Price (per 250 mg tablet) |
| U.S. |
$60–$70 |
$15–$25 |
| EU |
€45–€55 |
€12–€20 |
| Canada |
CAD 75–CAD 85 |
CAD 20–CAD 30 |
Price Trends
- Branded Zytiga prices have declined 10–15% since patent expiry.
- Generics price drops are steeper, reaching 40–60% reductions in the first two years post-market entry.
- Regional reimbursement policies significantly influence patient-out-of-pocket costs.
Future Price Projections
Over the next 3–5 years, generic prices are expected to decrease further by an additional 20–30% in mature markets, driven by increased competition.
Branded prices may stabilize or decline slightly due to market saturation and payer pressure. Specifically:
- U.S. branded prices may settle around $50 per 250 mg tablet.
- Generic prices could fall below $15 per tablet as multiple manufacturers enter the market.
Regulatory and Market Entry Factors
Generic manufacturing is generally supported after the expiration of patents and exclusivities:
- The primary patent for Zytiga expired in the U.S. in 2020.
- Several companies have launched generic versions in North America and Europe.
Regulatory approvals for generics typically take 6–12 months after patent expiry, depending on regional regulatory agencies, such as the FDA and EMA.
Strategic Implications for Stakeholders
- Pharmaceutical companies manufacturing generic Zytiga can expect margins to be squeezed as prices decline.
- Investors should monitor generic market penetration, which affects the revenue trajectory of branded therapies.
- Healthcare payers are incentivized to favor generics due to cost savings, influencing formulary decisions.
Key Takeaways
- NDC 00904-6939 corresponds to Zytiga (abiraterone acetate) 250 mg.
- The global prostate cancer market is worth over $7 billion, with Zytiga holding a significant but declining share.
- Patent expiration in major regions started in 2020, leading to increased generic competition.
- Prices for generics have decreased sharply, with continued downward pressure expected.
- Future pricing will depend on regional policies, market penetration of generics, and payer strategies.
FAQs
Q1: When did patent expiry for Zytiga occur in the U.S.?
A1: The primary patent expired in 2020.
Q2: What is the main driver behind generic price declines?
A2: Increased market competition following patent expiry reduces prices.
Q3: How does regional regulation impact generic pricing?
A3: Stringent regulatory standards can delay market entry but generally lead to more uniform pricing once approved.
Q4: What are the key markets for Zytiga?
A4: The U.S., Europe, and Japan are the largest markets, accounting for over 70% of sales.
Q5: Will branded Zytiga maintain significant market share?
A5: Market share is declining due to generics, but brand loyalty and formulary restrictions may sustain some sales.
References
[1] Fortune Business Insights. (2022). Prostate Cancer Drugs Market Size, Share & Industry Analysis. https://fortuneinsights.com
[2] IQVIA. (2022). Global Oncology Market Data.
[3] U.S. Food and Drug Administration. (2020). Abiraterone Acetate—Drug Approval and Patent Data. https://www.fda.gov
[4] European Medicines Agency. (2021). Regulatory approval for generic Zytiga. https://www.ema.europa.eu
