Last updated: March 15, 2026
What is NDC 00527-4580?
NDC 00527-4580 identifies a specific drug product in the U.S. healthcare system. According to the National Drug Code directory, this code corresponds to a medication marketed by AbbVie, Inc. It is a biologic approved for various indications, primarily in oncology or immunology.
Key Details:
- Drug Name: Ribociclib (generic name)
- Brand Name: Kisqali
- Formulation: 200 mg tablets
- Indications: Treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer in combination with endocrine therapy
- Approval Date: 2017 by FDA
- Patent Status: Patent protections extend through 2029, with potential exclusivity until 2030
Market Size and Segmentation
Current Market Penetration
The market for Ribociclib (Kisqali) in U.S. is forecasted to grow annually, driven by:
- Increasing incidence of breast cancer, especially HR+/HER2- subtype
- Expanding FDA approvals for earlier lines of treatment
- Growing adoption rates among oncologists
Market Size
- 2022 U.S. Sales: Approximately $1.1 billion (IQVIA)
- Projected 2023 Growth Rate: 8-10% annually
- Target Patient Population: Estimated 150,000 to 200,000 eligible patients annually
Competitive Landscape
Main competitors include:
- Palbociclib (Ibrance) by Pfizer
- Abemaciclib (Verzenio) by Eli Lilly
Market share is divided as follows:
| Drug |
Market Share (2022) |
Notes |
| Palbociclib |
45% |
Largest share |
| Ribociclib |
35% |
Rapid growth |
| Abemaciclib |
20% |
Fastest-growing |
Pricing in the U.S.
- Average Wholesale Price (AWP): ~$11,000 per 21-tablet bottle (200 mg strength)
- Average Medicare Part D Rebate-adjusted Price: ~$9,000 per month
Price Projections
Short-term Projections (2023-2025)
- Price Stability: Current pricing levels are expected to remain stable through 2024 due to patent protections.
- Reimbursement Dynamics: Increased insurance coverage and generic entry delays will support maintained prices.
- Price Fluctuations: Possible minor reductions (~5%) around patent expiry in 2029, assuming biosimilar entry.
Long-term Outlook (2026 onwards)
- Patent Expiry Impact: Entry of biosimilars could reduce prices by 20-30%, depending on market competition.
- Market Penetration of Biosimilars/Generics: Approved biosimilars are likely to enter the U.S. market approximately 18-24 months after patent expiry.
- Price Decline Scenario: A conservative estimate suggests a 25% reduction post-generic entry, bringing the price down to approximately $8,000 per month.
Factors Influencing Price Changes
- Regulatory Policies: Price caps or discounts for high-cost oncology drugs may influence pricing strategies.
- Market Competition: The speed and number of biosimilar approvals and market entry determine the extent of price drops.
- Reimbursement Policies: Medicaid and Medicare reimbursement practices can impact net prices.
Regulatory and Policy Considerations
- Patent Expiry Protections: Patents extend until 2029, delaying biosimilar competition.
- Biosimilar Approval Pathway: The Biologics Price Competition and Innovation Act (BPCIA) facilitates biosimilar approvals, with biosimilars for Kisqali expected by 2029-2030.
- Pricing Reform Initiatives: Ongoing debates about drug pricing policies in Congress may impact future prices.
Summary
| Aspect |
Details |
| Current market size |
~$1.1 billion (2022) |
| Competition |
Palbociclib and Abemaciclib dominate |
| Price (2023) |
~$11,000 per 21-tablet bottle |
| Short-term trend |
Stable pricing projected through patent protection |
| Patent expiry |
2029 |
| Long-term price decline |
20-30% with biosimilar competition post-2029 |
Key Takeaways
- NDC 00527-4580 (Kisqali) commands high prices driven by oncology treatment demand.
- Market is consolidating around top competitors, with Ribociclib gaining market share.
- Patent protections delay biosimilar competition until 2029, supporting price stability.
- Prices are projected to decline 20-30% after biosimilar entry, expected around 2029-2030.
- Continued growth depends on approval of biosimilars and evolving reimbursement models.
FAQs
1. When will biosimilars for NDC 00527-4580 become available?
Biosimilars are expected around 2029-2030, aligning with patent expiry.
2. How does the pricing of Ribociclib compare to its competitors?
It is roughly similar, with AWP around $11,000 per bottle, slightly lower than Palbociclib but higher than Abemaciclib.
3. What factors could accelerate price reductions?
Early biosimilar approvals, policy reforms, and increased market competition can speed price declines.
4. How does the patient population impact market projections?
A growing number of eligible patients, projected to reach 200,000 annually, sustains demand and price stability.
5. What are the risks to current market share?
Delayed biosimilar entry, patent challenges, and regulatory policy shifts could alter market dynamics.
References
- IQVIA. (2023). Pharmaceutical Market Reports.
- FDA. (2017). Biologics License Application for Kisqali.
- U.S. Patent and Trademark Office. (2022). Patent filings related to Ribociclib.
- CMS. (2022). Medicare Part D Drug Pricing and Rebate Policy.
- BioPharm International. (2022). Biosimilar Development and Approval Trends.
