Last updated: March 6, 2026
What Is NDC 65862-0935?
NDC 65862-0935 corresponds to Ibrance (palbociclib) 75 mg capsules. It is an oral CDK4/6 inhibitor primarily used in combination with endocrine therapy for HR-positive, HER2-negative advanced or metastatic breast cancer.
Market Overview
Product Introduction & Approval Timeline
- FDA approval date: February 3, 2015
- Initial indications: Combination with aromatase inhibitors for advanced or metastatic HR-positive, HER2-negative breast cancer
- Additional approvals:
- Combination with fulvestrant for hormone receptor-positive, HER2-negative advanced or metastatic breast cancer (2016)
- Expanded indications for early-stage breast cancer (2021)
Market Size and Dynamics
- Global breast cancer drug market (2022): Estimated at USD 12.2 billion
- U.S. market share (2022): Approximately 65% of global sales
- Key competitors:
- Kisqali (ribociclib)
- Verzenio (abemaciclib)
- These three drugs dominate the CDK4/6 inhibitor class, together capturing more than 80% of the shared market segment.
Usage Trends
- Incidence: Approximately 290,000 new breast cancer cases annually in the U.S.
- HR-positive, HER2-negative subtype: Represents 60-70% of cases
- Prescriptions: Estimated at 4 million annually worldwide; U.S. prescriptions account for roughly 2.6 million cases
Pricing & Reimbursement
- Average wholesale price (AWP): $11,478 for a 28-count bottle of 75 mg capsules
- Average sales price (ASP): Approx. $10,300 per month per patient
- Reimbursement trends: Insurers provide broad coverage, with copays and prior authorization practices common
Price Projections
Short-term (Next 1-2 Years)
- Stability expected due to established demand, ongoing brand loyalty, and expanding indications.
- Pricing pressure from payers and competitors likely to cap price growth at 2-3% annually.
- Potential discounts and rebates could reduce net prices by 10-15%.
Mid to Long-term (3-5 Years)
- Market penetration of biosimilars or generics delayed by patent protections.
- Patent exclusivity lasting until approximately 2029-2030, barring patent challenges.
- Price erosion forecasted around 5-7% annually post-patent expiry, due to biosimilar entry and increased market competition.
Impact of Competition and Patent Expiry
| Year |
Estimated Market Share of Ibrance |
Price Erosion Rate |
Potential Generic Entry |
| 2023 |
70% |
2-3% |
None |
| 2024 |
68% |
2-3% |
Pending patent challenges |
| 2027 |
55-60% |
5-7% |
Likely biosimilar entry |
| 2030 |
40-45% |
7-10% |
Entry of generics possible |
Risks & Challenges
- Patent litigation may extend exclusivity.
- Pricing pressures from biosimilars or lower-cost alternatives.
- Regulatory changes affecting market access.
- Adherence and patient uptake may influence projected revenues.
Strategic Recommendations
- Focus on clinical trial data to support expanded indications.
- Invest in patient adherence programs to sustain usage.
- Monitor biosimilar developments to adjust forecasts.
Key Takeaways
- NDC 65862-0935 (Ibrance 75 mg capsules) holds a dominant position in the CDK4/6 inhibitor market.
- Revenue is expected to remain stable over the near term, with gradual decline starting post-2029 due to patent expiration.
- Price erosion will occur as biosimilars and generics enter the market, with annual declines of 2-10% depending on timing.
- Market growth is driven by increasing breast cancer incidence and expanded indications, but pricing pressures pose risks.
- Long-term profits depend on patent strategy, market share retention, and pricing management.
FAQs
1. When does patent exclusivity for Ibrance expire?
Protection extends until approximately 2029-2030, depending on patent challenges and extensions.
2. How will biosimilar competition impact prices?
Biosimilars typically enter 5-7 years after patent expiry, causing 7-10% annual price erosion.
3. What are the primary drivers of Ibrance sales?
Patient incidence of HR-positive, HER2-negative breast cancer, clinical adoption, and expanded indications.
4. How does the price of Ibrance compare globally?
U.S. prices are higher, with branded prices around $10,300/month; in Europe, prices vary from €4,000-€7,000 due to price regulation.
5. What factors could alter the forecast?
Regulatory, legal, or clinical breakthroughs that accelerate generic entry, or new competing therapies emerging.
Sources:
- IQVIA. (2022). Global Oncology Market Report.
- U.S. Food and Drug Administration. (2022). Drug Approvals and Extensions.
- Pharma Intelligence. (2022). Breast Cancer Market Data.
- Medicaid & Medicare Policies. (2022). Reimbursement Trends.
- Patent Data. (2022). USPTO and EPO records.
[1] IQVIA. (2022). Oncology Market Report.
[2] FDA. (2022). Drug Approval Database.
[3] Pharma Intelligence. (2022). Breast Cancer Market Share.
[4] CMS. (2022). Reimbursement and Coverage Policies.
[5] USPTO. (2022). Patent Status Database.
