Last updated: February 13, 2026
What Is the Drug Corresponding to NDC 69584-0183?
NDC 69584-0183 identifies Kisqali (ribociclib) 600 mg tablet, a cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor approved for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer.
Market Landscape
Market Size and Growth
- The breast cancer therapeutic market was valued approximately at $7.2 billion in 2022 and is projected to grow at a CAGR of 8.2% to reach $11.2 billion by 2030 (source: GlobalData).
- CDK 4/6 inhibitors, including Kisqali, comprise roughly 40–50% of this segment, indicating a market of approximately $3–3.6 billion in 2022.
Key Competitors
- Palbociclib (Ibrance) from Pfizer.
- Abemaciclib (Verzenio) from Eli Lilly.
- Kisqali is positioned against these as a frontline or second-line therapy.
Current Adoption and Prescriptions
- Kisqali’s prescriptions increased 12% annually over the past two years, driven by expanding indications and increased clinician acceptance.
- It holds around 25–30% of the CDK 4/6 inhibitor market share mid-2023.
Regulatory and Reimbursement Factors
- Approved for first-line and subsequent therapies.
- Reimbursement policies favor combination therapy with letrozole or fulvestrant, influencing prescribing patterns.
Price Points and Cost Analysis
Average Wholesale Prices (AWP)
| Drug |
600 mg Tablet |
Approximate Monthly Cost |
Source |
| Kisqali |
$300 per tablet |
$9,000 (30 tablets/month) |
GoodRx, Red Book |
| Ibrance |
$350 per tablet |
$10,500 |
GoodRx, Red Book |
| Verzenio |
$400 per tablet |
$12,000 |
GoodRx, Red Book |
Actual Reimbursement and Net Price
- The actual product cost to payers can be substantially lower than AWP due to discounts, rebates, and negotiated contracts.
- Industry estimates suggest net prices are roughly 40–60% of list price; therefore, Kisqali’s net monthly cost ranges between $3,600 and $5,400 in U.S. healthcare settings.
Price Projections (Next 3–5 Years)
Factors Affecting Price Trajectory
- Market Competition: As new CDK 4/6 inhibitors expand, price pressure is expected. Pfizer’s Ibrance and Eli Lilly’s Verzenio may lead to discounts to maintain market share.
- Generic Entry: No generic Kisqali is available yet; patent protections extend until at least 2030, favoring stable prices.
- Reimbursement and Payer Negotiations: Cost containment and value-based arrangements may exert downward pressure on net prices.
- Regulatory Changes: Potential shifts in pricing regulations or patent laws could influence long-term pricing.
Projected Price Trends
- Short-term (1–2 years): Prices are likely to stabilize, with potential minor reductions (5–10%) due to competitive bidding and contract negotiations.
- Medium-term (3–5 years): Prices may decline by 10–20%, influenced by increased competition and healthcare cost containment measures.
Market Penetration Strategies
- Expansion of indications (e.g., early-stage breast cancer) could increase sales volume, compensating for price reductions.
- Further real-world evidence demonstrating cost-effectiveness might justify stable or slightly increased pricing in specialized settings.
Risks and Opportunities
Risks
- Entry of generics or biosimilars post-patent expiration.
- Regulatory or reimbursement policies aimed at price controls.
Opportunities
- Growing prevalence of HR-positive breast cancer.
- Expansion into new indications or combinations.
Key Takeaways
- NDC 69584-0183 corresponds to Kisqali (ribociclib) 600 mg tablets.
- The U.S. market for CDK 4/6 inhibitors is approximately $3 billion annually.
- Current list prices for Kisqali hover around $9,000 per month, with net prices significantly lower.
- Price stability is expected over the next 1–2 years, with gradual declines anticipated due to competition and market dynamics.
- The patent protection until 2030 supports current pricing, but long-term prospects include potential price compression due to generics and policy changes.
FAQs
1. When is Kisqali due for patent expiration?
Patent protections generally extend until 2030, barring any legal challenges or extensions.
2. Are biosimilars available for Kisqali?
No. Kisqali is a small-molecule drug; biosimilar terminology applies to biologics.
3. How does Kisqali’s pricing compare with its competitors?
It is generally priced slightly lower than Verzenio and comparable to Ibrance, factoring in discounts.
4. What factors could influence Kisqali’s pricing besides competition?
Regulatory reforms, value-based pricing models, and reimbursement policies.
5. How will expanding indications affect the market?
Broadened indication scope can increase volume sales, potentially offsetting pricing reductions.
References
- GlobalData. "Breast Cancer Therapeutics Market Forecast." 2022.
- GoodRx. Kisqali Price Data. 2023.
- Red Book. U.S. Medicine and Drug Pricing. 2023.
- FDA. Kisqali (ribociclib) approval documents. 2017.
