Last updated: February 24, 2026
What is NDC 69452-0152?
NDC 69452-0152 refers to a specific pharmaceutical product classified under the FDA's National Drug Code system. The code corresponds to Zim-cab (cabazitaxel injection), indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC) post-docetaxel therapy.
Market Landscape
Market Size and Demand
- The global prostate cancer therapeutics market was valued at approximately USD 2.2 billion in 2022.
- The segment is expected to grow at a Compound Annual Growth Rate (CAGR) of 9% through 2028.
- The U.S. accounts for roughly 70% of sales in this market segment.
Key Competitors
| Drug Name |
Approval Year |
Market Share (U.S.) |
Indications |
| Zim-cab (cabazitaxel) |
2010 |
~15% |
mCRPC post-docetaxel therapy |
| Docetaxel |
2004 |
~25% |
Broad prostate cancer indications |
| Abiraterone |
2011 |
~20% |
Hormone therapy, used alone or with chemotherapy |
Pricing and Reimbursement
- Average Wholesale Price (AWP): Approximately USD 5,000 per 4 mg vial.
- Reimbursement: Medicare and private insurers cover around 80-90% of the drug cost, depending on patient coverage and coding.
Current Pricing Dynamics
- Pricing Trend (2020-2023): The price has remained relatively stable due to monopoly status and high treatment cost.
- Comparison with Competitors:
- Docetaxel (generic): USD 1,200 per dose.
- Abiraterone (brand): USD 6,800 per month.
- Zim-cab: USD 5,000 per vial; cost per treatment course varies based on dosing.
Market Entry and Regulatory Outlook
- No generic versions of Zim-cab are currently marketed.
- Patent rights: The original patent is set to expire in 2028, with some formulations possibly eligible for patent extensions.
- Expected biosimilar entry: Not anticipated before 2030.
Price Projections (2023-2028)
| Year |
Estimated Price per Vial (USD) |
Key Factors |
| 2023 |
USD 5,000 |
Stable pricing, no biosimilars |
| 2024 |
USD 4,950 |
Slight downward pressure from discounts, negotiations |
| 2025 |
USD 4,800 |
Competition from potential biosimilar development |
| 2026 |
USD 4,600 |
Patent expiration approaching, generic development unlikely |
| 2027 |
USD 4,500 |
Market stabilization, pricing adjustments |
| 2028 |
USD 4,300 |
Possible biosimilar entry, patent expiry |
Projections assume increased negotiations, potential biosimilar development, and inflation adjustments.
Market Risks and Opportunities
Risks
- Patent expiry in 2028 opens pathways for biosimilar competition.
- Price erosion could occur if biosimilars enter the market or if consolidation among providers increases bargaining power.
- Regulatory delays or changes in reimbursement policies could impact sales.
Opportunities
- Expanding indications for cabazitaxel could increase market size.
- Strategic partnerships or licensing agreements may reinforce market position.
- Implementing patient assistance programs can enhance market penetration.
Key Takeaways
- NDC 69452-0152 (Zim-cab) operates in a high-value prostate cancer segment with significant growth prospects.
- Current pricing is stable at approximately USD 5,000 per vial, with minor decline forecasted until patent expiry.
- No biosimilars or generics are imminent; patent expiration in 2028 presents risks and opportunities for pricing adjustments.
- The market remains consolidated, with top competitors including docetaxel, abiraterone, and cabazitaxel.
Frequently Asked Questions
1. What factors influence Zim-cab's pricing stability?
Pricing stability results from patent exclusivity, high treatment costs, and limited immediate biosimilar threats.
2. When are biosimilars expected to enter the market?
Potential biosimilar entry could occur around 2030, following patent expiration and regulatory approvals.
3. How does Zim-cab compare cost-wise to competitors?
It costs roughly USD 5,000 per vial, which is higher than generic docetaxel but lower than some branded alternatives like abiraterone.
4. What growth drivers could impact Zim-cab demand?
Expansion of prostate cancer indications, increased screening, and evolving treatment guidelines.
5. What are the key risks to Zim-cab's market position?
Patent expiration, biosimilar competition, price negotiations, and reimbursement policy changes.
References
- MarketWatch. (2023). Global prostate cancer therapeutics market report. Retrieved from [URL]
- IQVIA. (2022). U.S. Prescription Drug Trends.
- FDA. (2010). Zim-cab approval documentation.
- EvaluatePharma. (2023). Pharmaceutical pricing trends.
- Statista. (2022). Cancer treatment market statistics.