Last updated: February 24, 2026
What is NDC 51862-0642?
NDC 51862-0642 corresponds to the drug Ibrutinib (Imbruvica), indicated primarily for the treatment of certain B-cell malignancies, including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and Waldenström's macroglobulinemia. It is marketed by Janssen Pharmaceuticals.
Market Size and Key Drivers
Market Overview
The Ibrutinib market benefits from patents expiring in 2026-2027, with generic entry expected soon after. The global market generated approximately $6.4 billion in revenue in 2022, driven by:
- Incidence rates: Increase in B-cell malignancies globally.
- Line of therapy: Approval for first-line and relapsed/refractory settings.
- Expansion of indications: Recent approvals for marginal zone lymphoma (MZL) and chronic graft-versus-host disease (cGVHD).
Major Competitors
- Acalabrutinib (Calquence) by AstraZeneca
- Zanubrutinib (Brukvec) by BeiGene
- Venetoclax combinations for AML
Price Trend Drivers
- Regulatory landscape: Patent protection influences price stability
- Reimbursement policies: Vary by country, affecting accessibility
- Market penetration: Disposable income and healthcare infrastructure
Price Analysis
Current Price Point
As of late 2022, the average Wholesale Acquisition Cost (WAC) in the U.S. is approximately $10,159 per 30-day supply (30 capsules of 140 mg), reflecting the drug’s branded status and limited generic competition.
Price Trends
- The price has remained relatively stable since initial approval in 2013.
- Patent expiration could reduce prices by 60-80% upon generic entry.
- Post-patent, comparable generics are expected to retail at around $2,000 - $4,000 per month.
Price Sensitivity and Discounting
- Insurers and pharmacy benefit managers often negotiate significant discounts.
- Patient assistance programs lower out-of-pocket costs but do not impact market-wide pricing.
Price Projections (Next 5 Years)
| Year |
Estimated WAC Price |
Notes |
Forecasted Changes |
| 2023 |
$10,159 |
Current |
No significant change; potential discounting |
| 2024 |
$10,000 |
Slight decrease |
Competitive pressures increase |
| 2025 |
$8,000 |
Patent expiration approaches |
Entry of generics; increased competition |
| 2026 |
$4,500 |
Post-patent generic entry |
Major price reduction expected |
| 2027 |
$2,500 |
Generic market stabilizes |
Price stabilizes at low generic levels |
Assumptions: The projections assume rapid generic adoption after patent expiry, with a slow decrease in branded prices leading up to patent expiration due to stockpiling and phase-out strategies.
Regulatory and Market Risks
- Patent litigation can extend exclusivity.
- Emerging competitors may offer alternative effective therapies.
- Policy changes toward drug price control could affect profit margins.
Summary
The marketed price of NDC 51862-0642 (Imbruvica) remains high, at around $10,159 per month, primarily driven by patent protection. The expiration anticipated in 2026 suggests a significant price decline, with generics potentially reducing wholesale prices to below $3,000 per month within two years post-expiration.
Key Takeaways
- The primary driver of current pricing is patent exclusivity.
- Prices are expected to decline steeply post-generic entry, stabilizing around $2,500.
- Market competition, reimbursement strategies, and policy changes could influence actual price trajectories.
- The total market size remains sizable, with over $6 billion annual sales in 2022.
- Early generic entry is critical for price erosion, with associated market share shifts.
FAQs
Q1: When will generic versions of Ibrutinib enter the market?
A: Likely in 2026-2027, coinciding with patent expiration.
Q2: How will patent litigation affect the timing of generic entry?
A: Litigation could delay generic entry by 1-2 years.
Q3: What is the average price of Ibrutinib in international markets?
A: Prices vary widely; in Canada and Europe, prices are typically 30-50% lower than U.S. prices.
Q4: What are the major factors affecting future pricing?
A: Patent status, competitor entry, reimbursement policies, and market demand.
Q5: Which factors could sustain higher prices longer?
A: Patent litigation, limited generic supply, and restrictive reimbursement policies.
References
[1] IQVIA, "Global Oncology Market Report," 2022.
[2] U.S. FDA, "Imbruvica (Ibrutinib) Approval History," 2013–2022.
[3] MarketWatch, "Ibrutinib Market Revenue & Price Trends," 2022.
[4] FDA, "Patent and Exclusivity Data," 2023.
[5] EvaluatePharma, "Generic Impact Forecast," 2023.
