Last updated: March 13, 2026
What is NDC 47781-0468?
NDC 47781-0468 refers to a specific drug listed in the United States National Drug Code (NDC) system. Based on available data, this code is associated with Imbruvica (ibrutinib), a targeted therapy used primarily for certain hematologic cancers, including mantle cell lymphoma, chronic lymphocytic leukemia (CLL), and Waldenström’s macroglobulinemia (WM).
Market Overview
Therapeutic Area and Demand Drivers
Imbruvica's market is driven by the prevalence of its approved cancer indications. The drug addresses a significant segment of hematologic oncology, with the following specifics:
- Indications:
- Mantle cell lymphoma
- Chronic lymphocytic leukemia
- Waldenström’s macroglobulinemia
- Patient Population:
- Approximately 60,000 new cases of CLL annually in the U.S. (SEER, 2021)
- Mantle cell lymphoma accounts for 7% of non-Hodgkin lymphomas globally
- WM is rare but increasing awareness and testing are expanding its diagnosis
Competitive Landscape
Imbruvica's main competitors include:
- Gazyva (obinutuzumab) — often combined with chemotherapy
- Venclexta (venetoclax) — especially for CLL
- Zydelig (idelalisib) — now less commonly used due to safety concerns
Market Size and Revenue
In 2022, V Compart promotes Imbruvica as a top-selling oncology drug with global sales exceeding $5 billion. The U.S. accounts for roughly 85% of revenue, generating approximately $4.25 billion in annual sales.
Regulatory and Market Dynamics
- Patent Status: Exclusivity extensions through patents until 2028.
- Pricing Trends: Historically high, with list prices around $146,000 annually per patient in the U.S.
- Reimbursement: Favorable, driven by Medicare and commercial payers, but facing pressure to contain costs.
Price Projections and Market Trends
Current Pricing and Per-Patient Costs
| Parameter |
Detail |
| Average Annual List Price |
$146,000 |
| Discounted/Payor Actual Price |
Estimated at 20-40% below list price |
| Reimbursement Rate |
Approaches 95% for commercially insured patients |
Future Price Trends
| Year |
Price Projection |
Rationale |
| 2023 |
Stable at ~$146,000 |
Market saturation and patent protections support stability |
| 2024 |
Slight decrease (~3%) |
Payer pressure and biosimilar/competitor emergence |
| 2025 |
Stabilization or ~2% decline |
Expected biosimilar or generic competition may influence pricing |
| 2026-2028 |
Further decrease (~5–7%) |
Increased biosimilar entry and cost-containment trends |
Volume and Revenue Forecasts
- 2023-2025: Global sales estimated at $4.5–$5 billion annually.
- 2025-2028: Potential decline of 10–15% due to biosimilar competition and market saturation.
Impact of Biosimilars and Generics
- Biosimilar versions could enter the U.S. market around 2028.
- Price erosion of 20–30% likely across the board for branded biologics.
Key Market Risks and Opportunities
Risks
- Expiring patents and biosimilar competition.
- Pricing pressure from payers and government agencies.
- Market saturation in core indications.
Opportunities
- Expanded indications could sustain revenue.
- Combination therapies may mitigate generic erosion.
- Entry into emerging markets with higher price tolerances.
Summary
Imbruvica commands high pricing with stable demand driven by its indication profile. Market and price projections suggest minimal inflation, with potential moderate reductions from biosimilar competition starting around 2028. Revenue growth depends on new indications and geographic expansion. Price stability is expected through 2023–2024, followed by gradual declines aligned with biosimilar market entry.
Key Takeaways
- NDC 47781-0468 (Imbruvica) is a leading targeted therapy in oncology with annual U.S. sales exceeding $4 billion.
- Pricing remains high but faces pressure due to biosimilar entry, patent expirations, and payer cost containment.
- Per-patient costs are around $146,000 annually, with projections indicating slight declines and stabilization pending biosimilar market entry.
- The market's future depends heavily on regulatory decisions, patent protections, and the development of combination therapies.
FAQs
1. When will biosimilars for Imbruvica likely enter the market?
Expected around 2028, depending on patent challenges and regulatory approvals.
2. How will biosimilar entry impact drug prices?
Prices are projected to decrease by 20–30%, driven by competition and market dynamics.
3. Are there new indications that could sustain Imbruvica’s revenue?
Yes, ongoing research for additional hematologic and solid tumor indications could expand its market.
4. What are the main drivers of demand for this drug?
Prevalence of targeted cancers, especially CLL, mantle cell lymphoma, and WM, and the clinical preference for targeted therapies over chemotherapy.
5. How do payers influence pricing for Imbruvica?
They negotiate discounts, manage formularies, and employ utilization controls, which can lower net prices by 20–40% from list prices.
References
- SEER Cancer Statistics Review, National Cancer Institute, 2021.
- IQVIA, Market Insights: Oncology Drugs, 2022.
- Manufacturer’s FDA filings and pricing disclosures.
- Bloomberg Intelligence, Oncology Market Reports, 2022.
- CMS and private payor coverage policies, 2023.
[1] U.S. Food and Drug Administration (FDA). (2022). Imbruvica (ibrutinib) Approved Uses.
[2] IQVIA. (2022). Global Oncology Market Trends.
[3] National Cancer Institute. (2021). SEER Cancer Statistics.
