Last updated: February 13, 2026
Overview
NDC 00006-3080 is Abemaciclib, marketed under the brand name Verzenio by Eli Lilly & Co. It is a cyclin-dependent kinase 4 and 6 inhibitor indicated for the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. Since approval in 2017, Abemaciclib has gained market share among CDK4/6 inhibitors, primarily competing alongside Pfizer's Ibrance (palbociclib) and Novartis's Kisqali (ribociclib).
Market Size and Demand Dynamics
Historical Prescriptions and Sales Data
- 2017-2022 Sales Growth: Abemaciclib sales increased from approximately $20 million in 2017 to over $2 billion in 2022 (IQVIA, 2023).
- Market Share: As of 2022, Abemaciclib accounts for around 20-25% of the CDK4/6 inhibitor market, with Ibrance leading at roughly 60%, and Kisqali at 15-20% (Evaluate Pharma, 2023).
- Patient Population: Estimated annual eligible patients for CDK4/6 inhibitors in U.S.: 100,000+ based on breast cancer incidence statistics (SEER database).
Competitive Position
- Abemaciclib distinguishes itself with a twice-daily oral regimen, single-agent activity post-endocrine therapy, and a unique side effect profile.
- It has been approved for additional indications, like adjuvant high-risk early breast cancer, potentially expanding demand.
Market Drivers
- Rising breast cancer incidence globally drives demand for targeted therapies.
- Increasing adoption of oral oncolytics in treatment protocols.
- Expanded indications, notably the FDA approval in adjuvant settings (2021).
- Patents expire for several formulations beginning in 2027, potentially impacting revenues.
Pricing Analysis and Projections
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately $10,000 per 30-day supply (Micromedex, 2023).
- Average Actual Selling Price (ASP): Estimated at $8,200 for U.S. commercial payers (CMS data, 2023).
- Reimbursement varies based on negotiated pharmacy and insurance plans; out-of-pocket costs for patients range from $0 to ~$1,000.
Historical Pricing Trends
- U.S. list prices for oncology drugs tend to increase annually by 3-5%, influenced by R&D recovery, inflation, and market exclusivity.
- Price stagnation has been observed during patent expiration periods.
Future Price Projections (2023-2030)
| Year |
Estimated WAC per 30-day supply |
Assumptions |
| 2023 |
$10,000 |
Current pricing |
| 2024 |
$10,300 |
3% increase |
| 2025 |
$10,600 |
3% increase |
| 2026 |
$10,900 |
3% increase |
| 2027 |
$11,200 |
Patent expiry approaches; minimal increase |
| 2028 |
$11,200–$12,000 |
Potential price stabilization or slight hike |
| 2029 |
$11,200–$12,000 |
|
| 2030 |
$11,200–$12,000 |
Possible market-driven adjustments |
Note: Price hikes may decelerate pre-expiry due to market saturation, or accelerate if novel formulations or combination regimens emerge.
Impacts of Patent Expiry and Biosimilar Entry
- Patent for verzenio's primary formulations expected to expire around 2027.
- Licensing and biosimilar development could lead to price erosion, with potential reductions of 20-40% over the subsequent 2-3 years post-expiry, depending on market competition.
- Manufacturer strategies may include margin protection through extended formulations, new indications, or combination therapy patent filings.
Regulatory and Policy Influence
- Healthcare policy shifts, such as value-based pricing or formulary restrictions, could impact net prices.
- Negotiation with payers under the Inflation Reduction Act commitments may influence net reimbursement levels.
Key Factors Influencing Market and Pricing
- Competitor activity: Ibrance and Kisqali reformulations or pricing strategies.
- Innovative combination therapies or new indications.
- Patent litigation outcomes and exclusivity extensions.
- Patent expirations and biosimilar markets starting from 2027 onward.
- Global market growth, especially in emerging markets where price sensitivity is higher.
Summary
Abemaciclib (NDC 00006-3080) has sustained strong sales growth in the U.S., with prices that are projected to increase gradually until patent expiration around 2027. Post-expiry, prices are expected to decline, influenced by biosimilar entry and competitive pressures. Market expansion through new indications may offset some declines. Overall, the drug maintains a high-value position within breast cancer treated with CDK4/6 inhibitors.
Key Takeaways
- NDC 00006-3080's revenues will grow until 2027, then likely decline due to patent expiration.
- Price increases are currently capped at 3% annually but may accelerate slightly ahead of patent terms.
- Competition, biosimilars, and policy changes will shape long-term pricing trends.
- Expanded indications could sustain revenues beyond original patent life.
- Current list price: approximately $10,000 per month; future prices may reach $12,000 if market conditions allow.
FAQs
Q1: How do Abemaciclib’s prices compare to other CDK4/6 inhibitors?
A1: Abemaciclib’s current list price is roughly comparable to Ibrance and Kisqali, with slight variations. Ibrance’s average wholesale price is approximately $10,600 monthly, while Kisqali’s is around $11,000.
Q2: When will the patent for NDC 00006-3080 expire?
A2: The primary patents are expected to expire around 2027, with potential for extensions or new formulations providing exclusivity until 2030.
Q3: What factors could influence price reductions post-2027?
A3: Entry of biosimilars or generics, increased competition, and policy measures could lead to 20-40% price declines over a 2-3 year period after patent expiry.
Q4: Are there emerging indications that could extend market exclusivity?
A4: Yes, approvals for adjuvant high-risk early breast cancer, announced in 2021, may extend revenues through increased use and new payer coverage.
Q5: How do pricing policies impact access in emerging markets?
A5: Pricing is often lower, sometimes a fraction of U.S. prices, driven by affordability, reimbursement policies, and local patent enforcement.
Sources
[1] IQVIA Sales Data, 2023
[2] Evaluate Pharma, 2023
[3] CDC, SEER Database, 2022
[4] Micromedex, 2023
[5] FDA, Verzenio Label, 2021
[6] CMS Pricing Data, 2023
