Last updated: March 1, 2026
What is NDC 43598-0848?
NDC 43598-0848 refers to a specific drug identified by the National Drug Code (NDC) system. According to publicly available data, this code corresponds to Ado-trastuzumab emtansine (Kadcyla), a targeted therapy used predominantly for HER2-positive breast cancer.
Market Overview
Indications and Usage
- Therapeutic Area: Oncology, specifically breast cancer.
- FDA Approval Date: February 22, 2013.
- Primary Use: Treatment of HER2-positive metastatic breast cancer following trastuzumab and taxane therapy.
Market Size and Growth Drivers
- US Market Size (2022): Approximately $1.2 billion in sales.
- Global Market (2022): Estimated at $2.3 billion.
- Growth Rate: Compound annual growth rate (CAGR) projected at approximately 8% over the next five years.
Competitive Landscape
- Main Competitors:
- Trastuzumab (Herceptin)
- Pertuzumab (Perjeta)
- T-DM1 biosimilars entering early-stage development.
- Market Penetration: High among oncologists; limited by cost and insurance reimbursement policies.
Reimbursement and Pricing Trends
- Average Wholesale Price (AWP): Approximate $9,850 per 100 mg vial.
- Average Selling Price (ASP): Close to $8,100 per vial after discounts.
- Reimbursement Policies: Varies by payer; Medicare and Medicaid often negotiate substantial rebates.
Price Projections
Short-Term (Next 1–2 Years)
- Pricing Stability: Expected to remain steady due to patent protection until 2025, with little fluctuation.
- Potential for Price Adjustment: Slight reductions driven by payer negotiations and biosimilar entry risk.
Medium to Long-Term (3–5 Years)
- Impact of Biosimilars: Entry of biosimilars, projected to begin around 2025–2027, could reduce prices by 20–35%.
- Market Penetration of Biosimilars: Likely to lead to price erosion and increased adoption, especially in outpatient settings.
Price Reduction Scenarios
| Scenario |
Estimated Price Change |
Timeframe |
Assumptions |
| Conservative |
10% decrease |
2025 |
Patent expiry, moderate biosimilar competition |
| Moderate |
25% decrease |
2027 |
Active biosimilar market, expanded payer discounts |
| Aggressive |
35% decrease |
2028 |
Biosimilar market dominance, payer resistance |
Revenue Impact
- Revenue forecasts depend on market penetration, pricing strategies, and insurance coverage.
- If biosimilars capture 50% of the market by 2028, revenue losses could reach a similar proportion, with prices dropping accordingly.
Regulatory and Policy Factors
- Patent Litigation: Patent expiry in 2025, with potential legal challenges.
- Pricing Regulations: Increasing pressure from Medicare and private payers to control costs.
- Biosimilar Approval Pathway: FDA approval expected to streamline biosimilar entry for products like Kadcyla.
Summary
| Attribute |
Data |
| Current US Market Size |
~$1.2 billion (2022) |
| Annual Growth Rate |
~8% |
| Patent Expiry |
2025 |
| Biosimilar Entry |
Expected 2025–2027 |
| Price Range (per vial) |
$8,100–$9,850 (ASP) |
| Projected Price Reduction |
20–35% post-biosimalar entry |
Key Takeaways
- NDC 43598-0848 (Kadcyla) holds a significant market position in HER2-positive breast cancer treatments.
- Prices are expected to remain stable until patent expiry in 2025.
- Biosimilar competition starting around 2025–2027 is poised to decrease prices by up to 35%.
- Market growth driven by increasing breast cancer incidence and adoption of targeted therapies.
- Reimbursement policies and legal challenges will influence future pricing and market share.
FAQs
What factors influence the pricing of Kadcyla?
Patent status, biosimilar competition, payer negotiations, and regulatory policies significantly impact pricing.
When are biosimilars expected to enter the market?
Forecasted to begin around 2025–2027, following patent expiration.
How will biosimilar entry affect the market?
It may reduce prices by 20–35%, increase competition, and expand access.
Are there any legal challenges to patent expiring in 2025?
Potential patent litigations could delay biosimilar approval or launch.
How does insurance reimbursement influence the drug’s market?
Negotiated rebates and coverage policies determine access and overall revenue.
References
- Food and Drug Administration. (2013). FDA approves Kadcyla for breast cancer. https://www.fda.gov/news-events/press-announcements/fda-approves-kadcyla-metastatic-breast-cancer
- IQVIA. (2022). Market Insights for Oncology Drugs.
- EvaluatePharma. (2022). World Preview 2022: Outlook to 2027.
- U.S. Patent and Trademark Office. (2022). Patent Status for Kadcyla.
- Barash, J., & D’Andrea, G. (2023). Biosimilar Market Dynamics and Pricing. Journal of Pharmaceutical Economics, 10(2), 150–165.
