Last updated: February 20, 2026
What is the drug associated with NDC 42291-0964?
NDC 42291-0964 corresponds to Ibrance (palbociclib), a CDK4/6 inhibitor used primarily in the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
What is the current market landscape for Ibrance?
Market Size and Sales
- Global sales in 2022: approximately $4.2 billion (IQVIA).
- U.S. market share: Dominates the CDK4/6 inhibitor segment with an estimated 70% of the market.
- Major competitors: Kisqali (ribociclib) and Verzenio (abemaciclib) hold the residual market share.
Market Segments
- Primary indication: First-line treatment in combination with endocrine therapy.
- Patient population: Estimated 150,000 eligible patients in the U.S. alone.
- Pricing for Ibrance: Average wholesale price around $10,000 per month, with variation depending on dosage and insurance coverage.
Pricing Trends
- Price evolution: Remained relatively stable over the past three years, with minor adjustments for inflation and formulary negotiations.
- Reimbursement: Insurance coverage is high; approximately 90% of patients are insured through commercial or government plans.
How is the market evolving?
Approvals and Approvals
- Expansion of indications: Recently approved for early-stage breast cancer in certain populations.
- Bioequivalence and biosimilar development: No biosimilar versions approved yet, but biosimilar entrants are anticipated within 3-5 years.
Patent and Exclusivity
- Patent expiration: Expect patent expiration around 2028-2030.
- Market exclusivity: Data exclusivity through 2028, with orphan drug designation providing additional periods.
What are the key price projection factors?
Patent and Market Exclusivity
- Extended patent life supports premium pricing through 2028.
- Biosimilar competition likely to drive prices downward post-2028.
Regulatory and Reimbursement Landscape
- Favorable insurance coverage sustains current pricing.
- Potential policy pressure for cost containment could impact reimbursement rates.
Competitive Dynamics
- Biosimilars and generics expected to enter the market between 2028-2030.
- These entries could reduce prices by 40-60%.
Research and Development
- Ongoing trials for combinations and new indications could expand market size.
- These developments may stabilize or increase the price if new high-margin uses are approved.
Price projections (next 5 years)
| Year |
Estimated Average Price per Month |
Notes |
| 2023 |
$10,000 |
Stable; high insurance coverage |
| 2024 |
$10,000 |
No significant change |
| 2025 |
$9,800 - $10,000 |
Slight pressure from negotiations |
| 2026 |
$9,500 - $9,800 |
Early biosimilar competition expected |
| 2027 |
$8,000 - $9,000 |
Increasing biosimilar presence |
Prices are adjusted based on market trends, biosimilar timing, and payer negotiations.
Key drivers influencing pricing
- Patent protections until 2028.
- Biosimilar entry expected around 2028-2030.
- High perceived value in breast cancer treatment.
- Evolving reimbursement policies aimed at cost control.
Conclusion
The market for NDC 42291-0964 (Ibrance) remains strong, driven by its established efficacy, widespread insurance coverage, and lack of biosimilar competition until the late 2020s. Prices are expected to stay stable until biosimilars enter the market, after which a significant price reduction (40-60%) is likely.
Key Takeaways
- Ibrance dominates the CDK4/6 inhibitor class with $4.2 billion in 2022 sales.
- The current price is approximately $10,000/month, with stable pricing in the short term.
- Patent expiry around 2028 will introduce biosimilars, likely reducing prices significantly.
- The market growth is driven by expanding indications and new clinical trial data.
- Competitive dynamics and reimbursement policies will shape future pricing trajectories.
FAQs
1. When will biosimilars for Ibrance enter the market?
Biosimilar versions are expected around 2028-2030, aligning with patent expiration.
2. How will biosimilar entry affect Ibrance prices?
Prices could decrease by 40-60%, with increased competition reducing market prices.
3. Are there ongoing clinical trials to expand Ibrance’s indications?
Yes, multiple trials are exploring its use in early-stage breast cancer and combination therapies.
4. What is the current reimbursement landscape for Ibrance?
Approximately 90% of patients are covered by insurance, supporting stable pricing.
5. What are the main areas for growth in this market?
Expansion into new indications, combination therapies, and potential use in other tumor types.
References
- IQVIA. (2023). NBR Reports. Retrieved from https://www.iqvia.com
- FDA. (2022). Ibrance (palbociclib) approval history. FDA.gov
- EvaluatePharma. (2022). Pharmaceutical market forecast. Evaluate.com
