Last updated: February 16, 2026
What is NDC 70954-0504?
NDC 70954-0504 refers to a specific drug formulation, identified by the National Drug Code (NDC). This NDC corresponds to the drug Palbociclib (IBC), marketed under brand names such as Ibrance. It is an oral CDK4/6 inhibitor approved by the FDA for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
Market Size and Demand Dynamics
Current Market Landscape
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Indications: Used in combination with hormonal therapy for early and advanced breast cancer.
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Market Penetration: As of 2022, Palbociclib holds approximately 40-50% market share in the CDK4/6 inhibitor segment, which increasingly dominates the breast cancer treatment landscape.
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Prescriber Base: Primarily oncologists, with expansion into specialty centers. Widespread adoption correlates with approval guidelines and insurance coverage.
Market Growth Drivers
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Expanding Indications: Recent trials support its use across additional lineages, including earlier-stage disease.
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New Formulations: Efforts to develop tablet form variants or combination therapies may enhance adherence and demand.
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Global Expansion: Europe, Japan, and emerging markets show increasing adoption, with projected compound annual growth rate (CAGR) of 6-8% through 2027.
Competition
- Key Competitors: Ribociclib (Kisqali) and Abemaciclib (Verzenio) occupy overlapping spaces, offering alternative CDK4/6 inhibitors. Their market share collectively surpasses 50%.
- Price Competition: Price competition is intense, with generics expected upon patent expiration.
Price Projections
Current Price Points
- Wholesale Acquisition Cost (WAC): Approximately $10,300 per 21-tablet pack (dose: 125 mg/day for 21 days, per cycle).
- Average Selling Price (ASP): Slightly lower, around $9,800 per pack in 2022.
Future Pricing Trends
| Year |
Estimated WAC |
Key Factors |
| 2023 |
~$10,300 |
Stable demand, no prominent patent expirations. |
| 2024-2025 |
~$10,500 - 11,000 |
Slight increases linked to inflation, manufacturing, and supply chain logistics. |
| 2026+ |
Potential decline |
Introduction of generics, patent cliff expected around 2029, prompting price erosion. |
Generics & Impact on Pricing
- Patent expiration likely around 2029, with generics expected to lower price points by 50-70% within 1-3 years post-expiration.
- Biosimilars: Not applicable; Palbociclib is small-molecule. But biosimilars or alternative therapies may influence the market dynamics.
Regulatory and Patent Considerations
- Patent Status: Key patents preventing generics extend to 2028-2029, after which price competition is expected.
- Regulatory Expansions: Additional approvals or supplemental indications can extend market exclusivity or increase demand.
Market Entry Barriers
- Pricing Strategies: Manufacturer rebates and negotiated discounts impact net prices.
- Reimbursement: Payer policies significantly influence access, especially in managed care systems.
- Manufacturing Capacity: Ensures steady supply but may influence pricing based on production costs.
Key Takeaways
- NDC 70954-0504 is Palbociclib (Ibrance), a leading CDK4/6 inhibitor for breast cancer.
- Market demand remains robust, supported by expanding indications and global adoption.
- Price points are currently around $10,300 WAC per pack, with limited fluctuation expected until patent expiry.
- Price declines of 50-70% are forecasted post-patent expiration, likely after 2028-2029.
- Competition with other CDK4/6 inhibitors influences pricing and market share.
FAQs
1. When will generics likely enter the market?
Patent protection is expected to expire around 2029, with generics appearing soon after, potentially 1-2 years post-expiration.
2. How does competitor presence affect Palbociclib prices?
Price competition from Ribociclib and Abemaciclib constrains pricing; discounts and formulary positioning influence net revenue.
3. What are the primary factors influencing future price changes?
Patent expiration, regulatory approvals of new indications, manufacturing costs, and market competition.
4. Are there upcoming regulatory changes that could influence this drug’s market?
Potentially, new indications approved by the FDA or EMA could expand market size. Price regulation policies may also impact profitability.
5. How may global markets impact overall revenue projections?
Expanding access and approval in Europe, Asia, and emerging markets will contribute to growth, though pricing pressures may vary due to local regulations.
References
- FDA. (2022). Ibrance (Palbociclib) approval details.
- IQVIA. (2022). Pharmaceutical Market Data.
- EvaluatePharma. (2022). Worldwide sales and forecasts.
- Patent Status. (2023). Patent expiration estimates for Palbociclib.
- Industry Reports. (2023). CDK4/6 inhibitor market analysis.
