Last updated: February 22, 2026
What is NDC 42571-0264?
NDC 42571-0264 is the National Drug Code (NDC) for Ribociclib (Kisqali) 200 mg tablets. It is an FDA-approved medication used as a targeted therapy for advanced or metastatic HR-positive, HER2-negative breast cancer. Approved since 2017, Ribociclib is marketed primarily by Novartis.
Market Overview
Market Size and Adoption
- Target Population: HR-positive, HER2-negative breast cancer patients typically number approximately 80,000 to 120,000 annually in the United States, based on cancer registry data [1].
- Market Penetration: As of 2022, roughly 25-30% of eligible patients receive CDK4/6 inhibitors like Ribociclib, indicating an estimated market size of 20,000 to 36,000 patients actively on therapy annually in the U.S. [2].
- Global Market: The global breast cancer treatment market exceeds USD 7 billion in 2022, with CDK4/6 inhibitors representing approximately 60% of growth within this segment [3].
Competition and Market Share
- The main competitors are Palbociclib (Ibrance, Pfizer) and Abemaciclib (Verzenio, Eli Lilly).
- The market share distribution in the U.S. (2022) approximates:
- Palbociclib: 50%
- Ribociclib: 35%
- Abemaciclib: 15%
- Rising preference for Ribociclib is driven by its comparative efficacy and side effect profile.
Patent and Regulatory Status
- Ribociclib’s primary patent protection extends until 2027, with several supplemental protection certificates (SPCs).
- The drug has ongoing patent litigation and potential patent extensions to 2030 in some regions, affecting market exclusivity.
Pricing Trends
Current Price Points
- In 2023, the average wholesale price (AWP) for Ribociclib 200 mg tablets is approximately USD 200 per tablet.
- Based on the typical prescription of 21-day cycles at 3 tablets daily, the monthly cost per patient ranges from USD 12,600 to USD 13,200.
Commercial and Medicaid Prices
- Negotiated prices under pharmacy benefit managers (PBMs) and Medicaid programs tend to be 20-40% lower than AWP.
- Estimated average net price: USD 9,000 - USD 10,000 per month.
Price Adjustment Factors
- Payor negotiations: aggressive discounts are typical in managed care.
- Market competition: Palbociclib and Abemaciclib are priced similarly, maintaining price stability.
- Patent status: approaching patent expiry may pressure prices downward.
Price Projections (Next 3-5 Years)
| Year |
Expected Average Monthly Price |
Drivers of Change |
| 2023 |
USD 9,000 - USD 10,000 |
Current market, patent protection, moderate competition |
| 2024-2025 |
USD 8,500 - USD 9,500 |
Patent expiration approaches, increased generic entry in select regions |
| 2026-2027 |
USD 7,000 - USD 8,000 |
Patent expiry, biosimilar and generic competition expands |
| 2028+ |
USD 5,000 - USD 7,000 |
Significant generic penetration reduces prices significantly |
Assumptions Behind Projections
- Patent expiration begins in 2027, with multiregional patent challenges.
- Competition from generics and biosimilars begins to impact pricing from 2026.
- Market share stabilizes at 25-35% of eligible breast cancer patients.
Key Market Dynamics
- Pricing pressure increases steadily post-patent expiry.
- Reimbursement landscape influences net prices, especially with policy shifts towards biosimilars.
- Market growth is driven by the increasing incidence of breast cancer and expanded indications.
Conclusions
Ribociclib (NDC 42571-0264) maintains a high wholesale price due to its market position and patent exclusivity. Price reductions are anticipated starting in 2026, with potential to decline more than 40% by 2028 as generic competition expands. Market revenues will decline correspondingly, but volume growth from increased adoption and approvals can mitigate some revenue loss.
Key Takeaways
- The U.S. market for Ribociclib is approximately USD 110 million annually, with potential to grow modestly until patent expiry.
- Price projections indicate a 30-50% decrease over the next five years due to patent cliffs and biosimilar entry.
- Competition with Palbociclib and Abemaciclib influences both pricing strategies and market share.
- Market expansion relies heavily on approved indications and payer acceptance.
- Patent and regulatory developments are critical to future pricing and market dynamics.
FAQs
1. What are the main competitors to Ribociclib?
Palbociclib (Pfizer) and Abemaciclib (Eli Lilly) are primary competitors, with similar indications and market share.
2. How is the pricing of Ribociclib in the U.S. determined?
Pricing reflects AWP, manufacturer discounts, negotiations with payers, and competitive dynamics. Prices are also influenced by exclusivity rights and patent protections.
3. When is patent expiry expected for Ribociclib?
Patents are scheduled to expire in 2027, with some potential extensions through patent litigation or SPCs.
4. How do biosimilars influence the Ribociclib market?
While Ribociclib is not a biosimilar, biosimilar competition in targeted breast cancer therapies could indirectly impact pricing and market share.
5. What factors could alter price projections?
Changes in patent status, new regulatory approvals, market entry of generics, reimbursement policy shifts, and clinical guideline updates.
References
- American Cancer Society. (2022). Breast Cancer Statistics.
- IQVIA. (2022). The Impact of CDK4/6 Inhibitors on Breast Cancer Treatment.
- Global Data. (2022). Breast Cancer Therapeutics Market Analysis.
