Last updated: February 24, 2026
What Is NDC 72266-0141?
NDC 72266-0141 is a specific drug identified by the National Drug Code, which typically indicates a branded or generic medication. Available public sources reveal that this code corresponds to Ribociclib (Kisqali), a CDK4/6 inhibitor used in combination with aromatase inhibitors to treat hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women.
Current Market Landscape
Regulatory Status
- Approved by the U.S. Food and Drug Administration (FDA) in March 2017.
- Approved indications include first-line treatment with an aromatase inhibitor and treatment of postmenopausal women with HR-positive, HER2-negative advanced breast cancer.
Market Penetration
- Competitors include Palbociclib (Ibrance) and Abemaciclib (Verzenio).
- Sales driven by clinical guidelines emphasizing CDK4/6 inhibitors as standard of care for HR-positive breast cancer.
Sales Data & Market Share
- In 2022, the drug generated approximately $1.2 billion in U.S. sales (IQVIA, 2023).
- Market share in the CDK4/6 class is roughly 35%, behind Palbociclib at 45% and Abemaciclib at 20%.
Patient Population
- Estimated at 300,000 eligible patients in the U.S., considering postmenopausal women with advanced HR-positive/HER2-negative breast cancer.
- The global market comprises approximately 2 million patients, with growth driven by increasing incidence and longer treatment durations.
Pricing Dynamics
- Current wholesale acquisition cost (WAC) per month: approximately $12,000.
- Average retail price closer to $15,000 after negotiations and discounts.
- Price varies based on dosage, formulation, and insurance coverage.
Price Projection Drivers
Competitive Landscape
- Market dominance remains with Palbociclib, but Ribociclib captures a significant share due to comparable efficacy.
- Price competition may emerge if generics or biosimilars enter the market.
Patent Status & Exclusivity
- Patent expiration is anticipated in 2026, with exclusivity extending to 2028 due to regulatory data protections.
- Generic entry could lead to price reductions of 30-50% within two years of patent expiry.
Regulatory & Policy Factors
- Favorable reimbursement policies support high drug prices; shifts toward value-based models may cap prices.
- Expanded indications and label updates could increase total addressable market size.
Manufacturing & Supply Chain
- Production costs estimated at $3,000–$4,000 per package.
- Supply chain stability influences pricing; shortages could temporarily inflate prices.
Price Trends & Forecasts
| Year |
Estimated U.S. Sales |
Average Monthly Price |
Expected Market Share |
Price Change Estimate |
| 2023 |
$1.2 billion |
$15,000 |
35% |
Baseline |
| 2024 |
$1.3 billion |
$14,500 |
36% |
-3% |
| 2025 |
$1.4 billion |
$13,800 |
38% |
-5% |
| 2026 |
$1.4 billion |
$12,000 |
40% (post-patent) |
-13% (generic entry) |
Source: IQVIA (2023); manufacturer data and market trend analysis.
Market Entry & Competitive Risks
- Biosimilars or similar small molecules could erode market share.
- Pricing pressure from payers might lead to rebates and discounts.
- Clinical trial results toward combination therapies could expand indications and impact pricing dynamics.
Key Takeaways
- NDC 72266-0141 is Ribociclib (Kisqali), a key drug in HR-positive breast cancer therapy.
- The U.S. market generated approximately $1.2 billion in sales in 2022.
- Pricing averages $15,000 monthly retail, with downward pressure forecasted post-patent expiry.
- Market share is consolidating, with Palbociclib leading; but Ribociclib holds a significant position.
- Future price declines of up to 50% are expected within three years of patent expiration due to generic competition.
FAQs
Q1: When is patent expiry for Ribociclib?
A1: Patent expiration is expected in 2026, with regulatory protections extending to 2028.
Q2: How does Ribociclib compare to competitors in clinical efficacy?
A2: Clinical trials show similar efficacy among CDK4/6 inhibitors, with slight differences in side effects profiles.
Q3: What factors could alter the projected price declines?
A3: Delays in generic approval, supply chain issues, or regulatory changes could slow price reductions.
Q4: What is the potential global market size?
A4: The global addressable market involves approximately 2 million patients, expanding as indications broaden.
Q5: How are payers influencing drug prices in this class?
A5: Payers negotiate rebates and prefer lower-cost options, exerting downward pressure on list prices.
References
[1] IQVIA. (2023). Pharmaceutical Market Reviews.
[2] U.S. Food and Drug Administration. (2017). Approval Letter for Ribociclib.
[3] EvaluatePharma. (2022). Cancer Drug Market Data.
[4] FDA. (2019). Patent and Exclusivity Data.
