Last updated: February 20, 2026
What is the drug associated with NDC 00116-4024?
NDC 00116-4024 refers to Ibrance (palbociclib), a selective CDK4/6 inhibitor approved for the treatment of HR-positive, HER2-negative metastatic breast cancer. It is marketed by Pfizer.
Market Overview
| Market Segment |
Details |
| Indication |
HR-positive, HER2-negative breast cancer |
| Approved Use |
Metastatic, early-stage in combination with endocrine therapy |
| Peak Sales (2022) |
Approximately $4.8 billion globally (Pfizer) |
| Patent Status |
Patent expiring in the U.S. in 2028; generics expected thereafter |
| Competition |
Other CDK4/6 inhibitors: Ribociclib (Kisqali), Abemaciclib (Verzenio) |
Current Market Dynamics
- Manufacturer: Pfizer holds U.S. patent rights until 2028, with patent extensions possibly extending exclusivity.
- Pricing: List price per month ranges from $12,000 to $13,000; actual net prices vary due to discounts and rebates.
- Reimbursement: Usually covered under Medicare, Medicaid, and commercial insurance plans.
- Market Penetration: Widely adopted in advanced breast cancer treatments, with increasing use in earlier lines.
Patent and Regulatory Landscape
| Date |
Event |
Impact |
| 2015 |
FDA approval |
Introduction to market |
| 2018 |
Patent expiration in Europe |
Generic competition possible outside US |
| 2028 |
Patent expiry in US |
Entry of generic versions expected |
| 2024 |
Closing of pediatric exclusivity |
Additional market protection expires in some jurisdictions |
Price Projection Analysis
| Year |
Estimated Peak Price |
Forecast Notes |
| 2023 |
$13,000/month |
Premium pricing maintained, with discounts and rebates factored in |
| 2024 |
$12,000/month |
Slight price reduction anticipated due to market pressure and competition |
| 2025 |
$10,500/month |
Potential discounts increase; generic entry risk increases |
| 2026 |
$8,000–$10,000/month |
Depending on market volume and negotiations, prices could decline further after generics enter |
| 2028 |
Entry of generics |
Prices could fall 80–90% from peak branded prices, settling around $1,000–$2,000/month |
Market Entry of Generics
Patents expire in 2028 in the US, with patent litigations and settlements likely to influence timing. Generics can significantly cut prices, with initial launches possibly leading to a 70–90% price decrease relative to branded levels.
| Key Considerations |
Timeline |
Price Impact |
| Patent expiry |
2028 |
First generics could launch shortly after |
| Market entry |
2028–2029 |
Prices could drop rapidly as multiple generics compete |
| Pricing stabilization |
2030 |
Prices could stabilize at 10–20% of current branded levels |
Competitive Landscape
| Drug |
Market Share (2022) |
Key Features |
Price (per month) |
Patent Status |
| Ibrance (Palbociclib) |
70% |
First mover among CDK4/6 inhibitors |
$13,000 |
Patent until 2028 in US |
| Kisqali (Ribociclib) |
20% |
Similar efficacy, slightly different toxicity |
$12,500 |
Patent est. until 2027 outside US |
| Verzenio (Abemaciclib) |
10% |
Stronger in some early-line settings |
$13,200 |
Patent until 2029 |
Key Market Risks and Opportunities
Risks
- Patent expiration threatens revenue streams.
- Price erosion driven by generics.
- Market saturation in indicated populations.
- Regulatory changes could affect reimbursement.
Opportunities
- Expansion into early-stage breast cancer.
- Development of combination therapies.
- New formulations or dosing regimens extending patent life.
Key Takeaways
- NDC 00116-4024 (Ibrance) generated around $4.8 billion globally in 2022.
- Pfizer holds patent rights until 2028 in the US, with generic entry expected thereafter.
- Pricing is stabilizing at high levels ($12-13,000/month) but faces imminent decline upon patent expiry.
- Competitive landscape is mature, dominated by three main drugs with similar mechanisms.
- The upcoming patent cliff in 2028 will dramatically impact pricing and market share.
FAQs
Q1: When will generic versions of Ibrance become available in the US?
A1: Likely after patent expiration in 2028, with generic launches possibly within a year following.
Q2: How much could prices decrease once generics enter the market?
A2: Prices could drop 80-90%, falling to approximately $1,000–$2,000/month.
Q3: Are there ongoing patent litigations or challenges?
A3: Patent challenges may occur before 2028, but no major litigations have halted patent expiry.
Q4: What are key competitors to Ibrance?
A4: Ribociclib (Kisqali) and Abemaciclib (Verzenio). Both have similar efficacy profiles.
Q5: What new indications are in development for Ibrance?
A5: Trials are ongoing for early-stage breast cancer and combinations with other targeted therapies.
References
- Pfizer. (2022). Ibrance (palbociclib) prescribing information.
- IQVIA. (2022). Market share reports for CDK4/6 inhibitors.
- FDA. (2018). Patent and exclusivity data.[1]
- EvaluatePharma. (2022). Global oncology drug sales.
- U.S. Patent and Trademark Office. (2023). Patent expiry analysis.
