Last updated: February 22, 2026
What Is NDC 00517-0031?
NDC 00517-0031 is a drug marketed as palbociclib, primarily used in combination therapies for HR-positive, HER2-negative breast cancer. It is marketed under the brand name Ibrance by Pfizer.
Market Overview
Indication and Usage
Palbociclib is indicated for:
- Front-line treatment of advanced or metastatic ER-positive, HER2-negative breast cancer in combination with endocrine therapy.
- Treatment of HR-positive, HER2-negative advanced breast cancer after endocrine therapy failure.
Therapeutic Competition
Major competitors in this segment include:
- Ribociclib (Kisqali, Novartis)
- Abemaciclib (Verzenio, Eli Lilly)
Clinical and Regulatory Status
- Approved by the FDA in 2015.
- Approved by the EMA in 2016.
- Approved in multiple markets globally.
Sales Data
Pfizer's Ibrance achieved:
- Global sales of approximately $5.7 billion in 2022.
- North American sales represented nearly 75% of global revenue.
- Steady annual growth since launch, with a compound annual growth rate (CAGR) of approximately 24% over the past five years.
Market Penetration
- Dominates the HR+/HER2- breast cancer segment.
- Used in combination with aromatase inhibitors and fulvestrant.
- Growing adoption in early-line settings.
Price Point and Cost Analysis
Current Pricing
- In the U.S., the average wholesale price (AWP) per 28-count capsule (tablet strength varies) is approximately $10,000.
- Per-course costs range from $80,000 to $90,000, depending on dosage and treatment duration.
- Medicaid and commercial insurance purchasers often negotiate discounts, reducing patient out-of-pocket costs.
Price Trends
- Price has remained relatively stable since approval.
- Slight increases linked to inflation, distribution costs, and manufacturing expensiveness.
- No significant price erosion despite competition, due to patent exclusivity.
Patent Status and Market Exclusivity
- Patent protection until 2027; no foreseeable patent cliffs before this date.
- Pfizer’s patent estate for Ibrance includes a composition-of-matter patent expiring in 2027 and a method-of-use patent expiring in 2028.
Price Projections
Short-term (Next 1–2 years)
- Prices likely to stabilize amid steady demand.
- Marginal increases expected due to inflation and distribution costs.
- Competitive pressure from ribociclib and abemaciclib may push Pfizer to maintain pricing to sustain margins.
Medium-term (3–5 years)
- Patent exclusivity ends in 2027; biosimilar and generic entrants possible immediately thereafter.
- Price erosion driven by generic competition could range from 20% to 40% within two years post-patent expiry.
- Limited price cuts expected before patent expiry due to market inertia.
Long-term (Beyond 2028)
- Post-patent landscape: biosimilar and generic versions could expand.
- Potential for significant price reduction, possibly halving the current costs.
- Adoption of biosimilars could stimulate pricing competition.
Regulatory and Market Factors Impacting Price
- Regulatory delays or patent litigation could extend exclusivity.
- New indications or combination therapies may sustain or increase pricing.
- Health authority policies on drug pricing and reimbursement could influence list prices and discounts.
Conclusion
Pfizer’s Ibrance (NDC 00517-0031) commands a premium price within the breast cancer treatment segment, buoyed by patent protection until 2027 and strong clinical demand. Prices are expected to remain stable in the short term with potential declines after patent expiry, contingent on the entry of biosimilars and generics. Competition from ribociclib and abemaciclib may exert pressure on pricing strategies.
Key Takeaways
- NDC 00517-0031 (Ibrance) is a leading drug for HR+/HER2- breast cancer with $5.7 billion in global sales in 2022.
- Current U.S. prices hover around $10,000 per 28-count capsule, with annual treatment costs exceeding $80,000.
- Patent protections last until 2027; sizable price erosion anticipated after patent expiration.
- Competition from rival CDK4/6 inhibitors presents ongoing market pressure.
- Biosimilar and generic entry post-2027 could reduce prices by 40% or more.
FAQs
1. What are the main competitors to NDC 00517-0031?
Ribociclib (Kisqali) and abemaciclib (Verzenio) compete directly in the same therapeutic class.
2. How does patent expiry influence price projections?
Patent expiry in 2027 likely leads to biosimilar and generic entries, causing significant price declines over the subsequent two years.
3. Are there upcoming regulatory changes that could affect pricing?
Potential patent litigations or new indication approvals could influence market dynamics and pricing strategies.
4. What factors could maintain or increase the current price?
Introduction of new combination therapies, expanded indications, or delays in biosimilar entry could sustain higher prices.
5. How is market penetration affecting pricing?
Strong market share in U.S. and availability in multiple countries bolster pricing power, especially before patent expiration.
References
[1] Pfizer. (2023). Ibrance (palbociclib). Product label.
[2] IQVIA. (2023). National Prescription Audit.
[3] FDA. (2015). Approval of palbociclib for breast cancer.
[4] EMA. (2016). Summary of opinion for Ibrance.
[5] EvaluatePharma. (2022). Oncology drug sales analysis.
