Last updated: March 5, 2026
What is NDC 62135-0475?
NDC 62135-0475 refers to Verzenio (abemaciclib), a CDK4/6 inhibitor approved for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer. Approved by the FDA in 2017, Verzenio is marketed by Eli Lilly. Its indications include combination with endocrine therapy and as monotherapy in specific patient populations.
Market Overview
Current Market Size
- Global breast cancer therapeutics market (2022): Approximate valuation of USD 11.8 billion.
- CDK4/6 inhibitors segment (2022): USD 6 billion, comprising three approved drugs: Verzenio, Ibrance (palbociclib), and Kisqali (ribociclib).
- Verzenio's market share (2022): 30-35% within CDK4/6 class, estimated at USD 2.1-2.5 billion in sales globally.
Commercial Landscape
- Major competitors: Pfizer's Ibrance, Novartis's Kisqali.
- Market penetration: In the U.S., Verzenio has captured roughly 40% of CDK4/6 treatable patient population, driven by approval for monotherapy and combination use.
- Patient incidence: Approximately 150,000 new HR+/HER2- metastatic breast cancer cases annually in the U.S. (CDC data), with about 70-80% eligible for CDK4/6 therapy.
Key Geographic Markets
| Region |
Market Size (USD Billion, 2022) |
Growth Rate (CAGR 2022-2027) |
Market Drivers |
| United States |
4.0 |
8.0% |
High breast cancer prevalence, reimbursement pathways |
| Europe |
2.4 |
7.0% |
Expanding approval, increased screening |
| Asia-Pacific |
1.8 |
10.0% |
Growing healthcare infrastructure, rising cancer incidence |
Regulatory and Reimbursement Dynamics
- FDA approvals: Verzenio is approved for multiple clinical settings, including in combination with aromatase inhibitors or fulvestrant, and as monotherapy.
- Reimbursement status: Widely reimbursed in the U.S., Europe, and developed Asia. Reimbursement policies impact market penetration.
Price Dynamics and Projections
Current Pricing
- Average Wholesale Price (AWP) in the U.S.: USD 12,000–15,000 for a 28-day supply (approximately 120 mg daily dosage). Actual net price varies due to discounts, rebates, and insurance negotiations.
- Per-pill cost: Approx USD 70–85.
Pricing Trends (2020–2022)
- Price stability has persisted due to patent exclusivity and demand.
- Pricing reforms such as Value-Based Pricing (VBP) are being explored but are not widespread yet.
Price Projections (2023–2028)
| Year |
Estimated Price Range (USD per 28-day supply) |
Market Drivers |
| 2023 |
USD 13,500–16,000 |
No significant patent expirations, demand growth continues |
| 2024 |
USD 13,700–16,300 |
Inclusion in expanded treatment guidelines, price inelasticity persists |
| 2025 |
USD 14,000–17,000 |
Possible entry of biosimilars or generics in some markets |
| 2026 |
USD 14,300–17,500 |
Patent exclusivity maintaining, potential negotiations for discounts |
| 2027 |
USD 14,600–18,000 |
Patent cliffs approach globally, biosimilar influence on pricing |
Assumptions Behind Projections
- Patent protections extend until 2030 in key markets.
- No major regulatory or competitive disruptions.
- Pricing reflects inflation and increased formulary inclusion.
- Biosimilar and generic competition remains limited before patent expiry.
Impact of Patent Expiry and Biosimilars
- Patent expiration: Expected around 2030 based on current patent filings.
- Potential biosimilars: Limited due to the molecular complexity of abemaciclib but could influence pricing and market share by 2028.
- Pricing pressure: Likely to increase as biosimilars or generics emerge in the late 2020s, prompting price declines of 20-40%.
Strategic Considerations
- Market expansion: Growing approval in emerging markets could increase volume but pressure prices downward.
- Role of combination therapies: Patent protections and pricing will hinge on label expansions and new indications.
- Reimbursement policies: Shifts toward value-based arrangements may influence pricing structures.
Key Takeaways
- Verzenio commands a premium price supported by patent exclusivity, especially in the U.S. and Europe.
- Market growth is driven by increasing breast cancer incidence, expanded indications, and ongoing clinical data.
- Pricing is expected to remain relatively stable until patent expiration near 2030, with potential declines thereafter due to biosimilar competition.
- The competitive landscape remains tight, with Ibrance and Kisqali as primary rivals.
- Emerging markets could offer growth but may exert downward pressure on prices.
FAQs
1. What factors influence Verzenio's market share?
Treatment guidelines, clinical efficacy, safety profile, physician familiarity, reimbursement policies, and competitive activity in the CDK4/6 class.
2. When is patent expiration for Verzenio expected?
Approximately 2030 in the United States and Europe, pending patent filings and legal challenges.
3. How do biosimilars impact Verzenio’s pricing?
Limited currently; impact is expected to occur closer to patent expiry, potentially reducing prices by up to 30-40% through increased competition.
4. What are the key geographic growth opportunities for Verzenio?
Emerging markets in Asia-Pacific and Latin America, driven by rising breast cancer incidence and expanding healthcare infrastructure.
5. How might value-based pricing models affect future prices?
Such models could result in discounts linked to clinical outcomes, potentially reducing net prices but increasing market access.
Sources:
[1] GlobalData. (2022). Breast cancer therapeutics market analysis.
[2] IQVIA. (2022). US pharmaceutical market data.
[3] CDC. (2022). Breast cancer statistics.
[4] Eli Lilly. (2023). Verzenio product information and pipeline updates.
