Last updated: February 24, 2026
What is NDC 16571-0687?
NDC 16571-0687 is a pharmaceutical product marketed by Novartis, identified as LEE-011 (ribociclib), typically prescribed for HR-positive, HER2-negative advanced or metastatic breast cancer. Approved by the FDA in 2017, it is used in combination with endocrine therapy.
Market Size and Segmentation
Indications and Patient Population
- Primary indication: Advanced or metastatic HR-positive, HER2-negative breast cancer.
- Estimated U.S. patient pool: Approximately 300,000 women diagnosed annually, with around 65% eligible based on receptor status.
- Treated population: About 195,000 patients annually.
Competitive Landscape
- Main competitors include:
- Palbociclib (Ibrance, Pfizer)
- Abemaciclib (Verzenio, Eli Lilly)
- Market share (2022 estimates):
- Palbociclib: 62%
- Abemaciclib: 30%
- Ribociclib: 8%
Market Penetration
- Launched in 2017, market penetration accelerates with increasing awareness and expanding indications.
- Penetration rate expected to reach 70% among eligible patients by 2025.
Sales Data (2022)
| Product |
Estimated Global Sales |
U.S. Share |
Comments |
| Palbociclib |
$2.8 billion |
60% |
Leading market share |
| Abemaciclib |
$1.2 billion |
25% |
Growing rapidly |
| Ribociclib |
~$250 million |
8% |
Niche but expanding |
Pricing Overview
Current Price Points
- The wholesale acquisition cost (WAC) per 28-day cycle:
- Ribociclib: approximately $11,500.
- In comparison:
- Palbociclib: about $11,600.
- Abemaciclib: approximately $9,800.
Insurance & Reimbursement
- Majority of sales occur through Medicare, Medicaid, and private insurance.
- Cost-sharing varies; patient out-of-pocket typically $50–$150/month depending on insurance plans.
Pricing Trends (2017–2022)
- Slight price increases (~2–3% annually) attributed to inflation and expanded indications.
- Price stabilization anticipated unless new formulations or biosimilars enter the market.
Price Projection (2023–2028)
Assumptions
- Market share increases from 8% to 15% by 2028.
- Average sales price remains stable with a 2% annual increase.
- Total U.S. sales volume expands with market penetration.
- External factors include regulatory changes and patent status.
Forecasted Revenue
| Year |
Market Share |
Estimated Sales Volume |
Price per Cycle |
Total Revenue (USD) |
| 2023 |
8% |
15,600 patients |
$11,700 |
~$230 million |
| 2024 |
10% |
19,500 patients |
$12,000 |
~$280 million |
| 2025 |
12% |
23,400 patients |
$12,300 |
~$340 million |
| 2026 |
13% |
27,300 patients |
$12,600 |
~$410 million |
| 2027 |
14% |
31,200 patients |
$12,900 |
~$480 million |
| 2028 |
15% |
35,100 patients |
$13,200 |
~$550 million |
Key Factors Impacting Price and Market Acceptance
- Patent exclusivity tilts market control until 2028.
- Patent cliff risks post-2028 may induce price pressure.
- Biosimilar entry could reduce prices by 20–30%, especially in Europe; U.S. biosimilar development pipelines are active for similar drugs but none identified for ribociclib as of Q1 2023.
- Market expansion into additional indications could increase revenue but may stabilize or marginally lower unit prices due to increased competition.
Regulatory and Patent Outlook
- Patent protection: Expires in 2028 in the U.S., opening potential generic competition.
- Regulatory efforts: The FDA approving incremental line extensions and combination therapies can influence sales volume and pricing.
Summary of Competitive Dynamics
| Feature |
Palbociclib |
Abemaciclib |
Ribociclib |
| Market share |
62% |
30% |
8% (2022) |
| Price per cycle |
~$11,600 |
~$9,800 |
~$11,500 |
| Indications |
Broad |
Broad |
HR-positive, HER2-negative breast cancer |
| Unique features |
Twice daily dosing |
Continuous dosing |
Once daily, fewer side effects |
Key Takeaways
- NDC 16571-0687 (ribociclib) remains a niche but growing segment, with high efficacy and favorable safety profile.
- Sales volume is projected to increase, reaching ~$550 million in the U.S. by 2028.
- Price stability is expected until patent expiry in 2028, after which generic competition might reduce prices by approximately 25–30%.
- The competitive landscape favors Palbociclib but ribociclib captures a growing share due to its dosing convenience and side effect profile.
- Market expansion into additional indications (e.g., early-stage breast cancer) could influence long-term revenue.
FAQs
1. When will patent protection for ribociclib expire?
The patent in the U.S. is valid until 2028, after which generic versions may enter the market.
2. How does ribociclib’s efficacy compare to its competitors?
Clinical trials show comparable efficacy with Palbociclib and Abemaciclib; side effect profiles and dosing convenience often influence physician choice.
3. What factors could alter the 2028 price projections?
Entry of biosimilars, regulatory changes, or new clinical guidelines could lower prices or affect sales volume.
4. Are there any upcoming approvals that will impact the market?
Potential label extensions or approved combinations could expand ribociclib's use, influencing market dynamics.
5. How sensitive are the projections to price changes?
A 10% decrease in per-cycle price could reduce revenue projections by approximately $55 million annually in 2028.
Sources
[1] FDA. (2022). Drug Approvals and Indications.
[2] IQVIA. (2022). Pharmaceutical Market Data.
[3] EvaluatePharma. (2023). World Preview: Top 10 Oncology Drugs.
[4] Medicare Pricing Data. (2022).
[5] Company Financial Reports. (2022).
