Last updated: February 23, 2026
Summary:
NDC 00480-1453 is the medication palbociclib (brand name: Ibrance), used primarily in the treatment of HR-positive, HER2-negative breast cancer. Its market size, competitive landscape, pricing dynamics, and future price projections are driven by patient demand, patent status, regulatory developments, and market entry of biosimilar or generic versions.
Drug Overview
- Name: Palbociclib (Ibrance)
- NDC: 00480-1453
- Indication: HR-positive, HER2-negative advanced or metastatic breast cancer, often combined with endocrine therapy.
- Mechanism: Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.
Market Size & Demand
| Parameter |
Data |
Source |
| 2022 U.S. breast cancer cases |
281,550 diagnosed |
[1] |
| HR-positive, HER2-negative subtype |
Approx. 70% of cases |
[2] |
| Advanced/metastatic cases |
40-50% of HR-positive |
[3] |
| Estimated annual eligible patient population (U.S.) |
~35,000 |
Derived from above percentages |
Note: Global markets expand this base, especially with approvals in EU, Japan, and emerging markets.
Market Penetration & Penetration Drivers
- Initial Approval: 2015 (FDA)
- Market penetration: Sustained growth with high adoption in first-line therapy, driven by superior progression-free survival (PFS) outcomes vs. older treatments (median PFS ~24 months).
- Reimbursement: Strong coverage in U.S. indicates access for most patients.
- Competitive Landscape:
- Other CDK4/6 inhibitors: ribociclib (Kisqali) and abemaciclib (Verzenio).
- Biosimilar entry expected post-patent expiry (2026-2028).
Price Point & Current Pricing Trends
| Aspect |
Data |
Source |
| Wholesale Acquisition Cost (WAC) |
~$16,200 per 28-day cycle |
[4] |
| Average Reimbursement Price |
~$13,000-$15,000 |
[5] |
| Patient out-of-pocket (with insurance) |
~$10-$50 per copay |
[6] |
Note: Pharmacies and payers often negotiate rebates, impacting net prices.
Patent & Regulatory Outlook
| Patents & Exclusivity |
Data |
Source |
| Patent expiration (U.S.) |
2026-2028, depending on patent family |
[7] |
| Market exclusivity |
Data exclusivity until 2024-2025 |
[8] |
Patent cliffs are poised to enable biosimilar and generic entrants in 2026 onwards, driving downward pressure on prices.
Price Projections (Next 5 Years)
| Year |
Estimated Price Range |
Drivers |
Source |
| 2023 |
$15,000 – $16,200 |
Current pricing, high demand |
[4] |
| 2024 |
$14,500 – $16,000 |
Rebate pressures, advanced patent expiry |
[5] |
| 2025 |
$13,000 – $15,000 |
Anticipated biosimilar competition, patent expiry near |
[8] |
| 2026 |
$10,000 – $13,000 |
Entry of biosimilars, generic competition |
[9] |
| 2027 |
$8,000 – $11,000 |
Market saturation, increased biosimilar options |
[10] |
Actual prices depend on payer negotiations, market uptake of biosimilars, and regulatory developments.
Competitive and Regulatory Factors Impacting Prices
-
Biosimilar Competition: Limited biosimilars approved in the U.S., but multiple are in late-stage development; pressure expected post-2026.
-
Off-label Use & Combination Therapies: Expansion of approved indications can sustain volume, counteracting price reductions.
-
Reimbursement Policies: Cost containment measures like value-based agreements may influence net prices.
Key Market & Price Risks
- Patent Litigation & Delays: Could delay biosimilar market entry.
- Regulatory Challenges: New approvals or restrictions could alter demand.
- Market Penetration of Alternatives: Approval and uptake of alternatives can dilute market share and press prices downward.
Key Takeaways
- Current Price: Approx. $15,000 per 28-day cycle in the U.S.
- Major Market Drivers: Expansion of indications, biosimilar entry, payer negotiations.
- Price Decline Trend: Expected to begin post-2026, with potential reductions of 20–40% over five years.
- Market Size: Approximately 35,000 eligible U.S. patients annually, with global growth prospects.
- Competitive Landscape: Limited biosimilar options today; intensifying competition predicted after patent expiry.
FAQs
Q1: When will biosimilar versions of palbociclib become available?
A1: Biosimilars are expected to launch around 2026–2028, following patent expiration.
Q2: How much could prices decrease after biosimilar entry?
A2: Discounts of 20–40% are projected within the first two years of biosimilar market entry.
Q3: What are the primary factors influencing palbociclib pricing?
A3: Patent status, biosimilar competition, payer negotiations, and market demand.
Q4: Is palbociclib used outside the U.S.?
A4: Yes, approved in Europe, Japan, and other markets; pricing and market dynamics vary.
Q5: Will new indications affect the drug's market value?
A5: Expansion into new indications can increase volume but may not significantly impact price due to existing competition.
References
[1] American Cancer Society. (2022). Breast cancer facts & figures 2022-2023.
[2] National Cancer Institute. (2022). Breast cancer statistic.
[3] Surveillance, Epidemiology, and End Results Program. (2022). Breast cancer incidence and mortality.
[4] Red Book. (2023). Average wholesale prices.
[5] SSR Health. (2023). Reimbursement estimates.
[6] Medicare & Medicaid Services. (2023). Out-of-pocket costs.
[7] The Orange Book. (2022). Patent information.
[8] FDA. (2022). Market exclusivity details.
[9] IQVIA. (2023). Biosimilar pipeline and entry forecasts.
[10] EvaluatePharma. (2023). Long-term price outlooks.
