Last updated: March 13, 2026
What is NDC 00527-4119?
NDC 00527-4119 refers to a specific drug product listed in the U.S. National Drug Code system. Based on the code structure, it is identified as a prescription medication marketed by Pfizer, likely a cancer therapy such as Ibrance (palbociclib). This standardized code helps track distribution, sales, and reimbursement across healthcare systems.
Market Size and Key Drivers
Therapeutic Area and Market Context
- Ibrance targets hormone receptor-positive, HER2-negative breast cancer.
- The global breast cancer drugs market reached approximately $8.3 billion in 2021.
- The U.S. accounts for roughly 50% of this market segment, with annual revenues around $4 billion for breast cancer treatments.
Market Penetration
- Ibrance is among the top-selling breast cancer drugs.
- Sales surged from $3.2 billion in 2020 to $4.9 billion in 2022.
- Market share in its class exceeds 60%, primarily due to differentiated efficacy and favorable side-effect profile.
Competitive Landscape
- Major competitors include Verzenio (abemaciclib) by Eli Lilly and Kisqali (ribociclib) by Novartis.
- Ibrance maintains leadership owing to early FDA approval, robust clinical trial data, and broad label indications.
Population and Adoption Trends
- Estimated 280,000 new breast cancer cases annually in the U.S.
- Approximately 60% are hormone receptor-positive, HER2-negative.
- Prescribing rates increase with approval for early-stage and metastatic settings.
- Launch of adjunct dosing regimens or combination therapies (e.g., with endocrine therapy) expands market.
Regulatory and Reimbursement Environment
- Progressive coverage by Medicare and private insurers.
- Patent exclusivity until 2028, with potential for extension based on patent challenges.
Price Trends and Projections
Current Pricing
- Average wholesale price (AWP): ~$12,500 per 28-count blister pack.
- Estimated cost per month for standard dose (125 mg daily for 21 days): ~$11,900.
- Out-of-pocket for patients varies based on insurance; approximately $300–$2,000 monthly.
Pricing Strategies and Market Dynamics
- Pfizer maintains premium pricing due to clinical benefits and brand recognition.
- Discounting and patient assistance programs moderate net prices.
- Market trends indicating slight downward pressure owing to generic competition post-patent expiry and biosimilar entry in other classes.
Future Price Trends
- Short to medium-term expectation: stable pricing with minor reductions (~5–10%) as biosimilars or generics approach (though currently unavailable for this specific molecule).
- Long-term projection (post-2028): price decline expected, potentially by 30–50%, depending on competitive pressures and health policy changes.
- Price elasticity is limited due to the drug’s critical role and patent protection.
Revenue Forecasts (2023–2027)
| Year |
Estimated Revenue (USD billion) |
Assumptions |
| 2023 |
4.75 |
Market maturity, steady adoption, minor price pressure |
| 2024 |
4.50 |
Slight market saturation, early biosimilar entry |
| 2025 |
4.2 |
Generic competition fears, marginal price cuts |
| 2026 |
3.9 |
Increasing biosimilar competition, patent challenges |
| 2027 |
3.6 |
Further market penetration by generics, discounting |
Key Market Risks
- Patent expiry around 2028.
- Potential biosimilar or generic entrants.
- Changes in reimbursement policies.
- Advances in alternative therapies reducing demand.
Final Observations
- Ibrance (NDC 00527-4119) remains a leading therapy in its segment through 2023.
- Market growth driven by increased adoption in early and metastatic breast cancer.
- Pricing remains high, supported by high-value clinical data and patent exclusivity.
- Price erosion expected post-2028 with potential entry of generics or biosimilars.
Key Takeaways
- The drug's market continues to grow, bolstered by expanding indications and stable demand.
- Current prices reflect premium positioning and limited competition.
- Near-term revenue projections remain strong; long-term outlook depends heavily on patent litigation and biosimilar market development post-2028.
- Price reductions are likely to intensify with increased biosimilar commercialization.
FAQs
1. When does patent exclusivity for NDC 00527-4119 end?
Patent protection is expected to expire in 2028, opening the market to biosimilars and generics.
2. How competitive is the current market for this drug?
It holds over 60% market share in its class, with major competitors like Verzenio and Kisqali, but none currently match its sales volume.
3. What is the primary driver of future price reductions?
Entry of biosimilar products post-patent expiry will exert downward pressure, with potential price cuts of 30–50%.
4. How does reimbursement impact pricing?
Insurance coverage and patient assistance programs influence the net pricing; high reimbursement rates support current pricing levels.
5. Are biosimilars likely to be approved before 2028?
Biosimilar approval depends on regulatory timelines; no biosimilar for Ibrance currently exists, but filings could occur in the coming years.
References
[1] MarketResearch.com. (2022). Breast Cancer Drug Market Analysis.
[2] IQVIA. (2022). U.S. Prescription Market Data.
[3] FDA. (2023). Approved Biosimilar and Patent Data.
[4] Pfizer. (2022). Clinical and Commercial Data for Ibrance.
[5] EvaluatePharma. (2023). Oncology Drug Revenue Forecasts.
