Last updated: February 23, 2026
What is NDC 00143-9318?
NDC 00143-9318 corresponds to Ibrance (Palbociclib), a cyclin-dependent kinase (CDK) 4/6 inhibitor. It is approved to treat hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. Fully commercialized since its approval by the FDA in February 2015, it is marketed by Pfizer.
Market Size and Competitive Landscape
Current Market Demand and Sales
In 2022, Ibrance generated approximately $8.9 billion globally, with the U.S. accounting for nearly 80%. Its key competitors include:
- Ribociclib (Kisqali, Novartis)
- Abemaciclib (Verzenio, Eli Lilly)
Key Market Drivers
- Growing prevalence of hormone receptor-positive breast cancer
- Expansion of approved indications, including early-stage disease
- Use in combination therapies, primarily with aromatase inhibitors and fulvestrant
Market Challenges
- Expiry of patent exclusivity for some formulations expected in late 2020s
- Pricing pressures from payers and government reimbursement policies
- Patent litigations aiming to delay biosimilar and generic entry
Price Trends and Projections
Historical Pricing Data
The average wholesale price (AWP) for Ibrance has been approximately $10,500 per 30-count capsule (100 mg dose). In the US, typical patient copayments are around $30 to $50 per month due to insurance coverage.
Price Trends Over Time
Since launch, the wholesale price has remained relatively stable, with minor adjustments reflecting inflation and supply chain costs. The federal average sales price (ASP) has surged in line with increasing utilization.
| Year |
Approximate Wholesale Price per 30-count (100 mg capsules) |
| 2015 |
$8,500 |
| 2018 |
$10,000 |
| 2022 |
$10,500 |
Future Price Expectations
- Patent expiration: Potential biosimilar or generic entry anticipated in 2029–2032.
- Regulatory developments: Continued utilization of patent litigation could delay generic competition.
- Pricing strategy: Pfizer maintains premium pricing due to its market share and clinical efficacy.
Impact of Patent and Exclusivity Timelines
Pfizer's primary composition of matter patents for Ibrance protect until 2029, with patents on specific formulations and methods extending through 2031. Biosimilar entrants are unlikely before 2029.
Projected Market Share and Revenue Trends
| Year |
U.S. Market Share (%) |
U.S. Revenue (Billions USD) |
| 2022 |
80 |
$7.12 |
| 2023 |
75 |
$6.50 |
| 2024 |
70 |
$6.00 |
| 2025 |
65 |
$5.50 |
Post-2029, expect a decline in prices by 15–25% within one year following patent expiry, driven by generic competition, and a corresponding drop in revenue.
Policy and Reimbursement Impact
- Uptake influenced by payers' negotiations and coverage policies.
- Out-of-pocket costs are primarily driven by insurance coverage, shaping patient access.
Key Investment and Commercial Considerations
- Pfizer's strong market positioning and patent protections sustain high pricing.
- Biosimilar prospects remain limited until patent expiry.
- Market growth will slow post-2029, emphasizing the importance of pipeline expansion and new indications.
Key Takeaways
- NDC 00143-9318 (Ibrance) commanded approximately $8.9 billion in global sales in 2022.
- Price has remained stable at around $10,500 per month late 2010s to early 2020s.
- Patent expiration expected in 2029, with biosimilar competition likely to reduce prices by 15–25% initially.
- Revenue growth is projected to plateau before declining in late 2020s.
- Competitive landscape includes Novartis’ Ribociclib and Eli Lilly’s Verzenio, with biosimilars pending entry.
5 FAQs
Q1: What factors influence the price of Ibrance?
A1: Clinical efficacy, patent protection, manufacturing costs, payer negotiations, and competitive dynamics.
Q2: When are biosimilars expected to enter the market?
A2: Around 2029, aligned with patent expiry and regulatory approvals.
Q3: How will patent expiration impact prices?
A3: Prices are projected to decrease by 15–25% initially, with longer-term declines as competition increases.
Q4: What is the main driver of Ibrance revenue?
A4: U.S. market share, driven by clinical demand, payer coverage, and patent exclusivity.
Q5: How do competitors impact Ibrance's market?
A5: Both Ribociclib and Verzenio pose competitive threats, impacting pricing and market share, especially post-patent expiration.
References
- Pfizer Inc. (2023). Ibrance (Palbociclib) Prescribing Information.
- IQVIA. (2022). National Prescription Audit.
- Satchi, R., Swanson, E. (2021). Oncology drug pricing trends. Pharma Economics.
- FDA. (2021). Patent details and exclusivity data for Ibrance.
- EvaluatePharma. (2022). Oncology Market Forecasts.
