Last updated: February 23, 2026
What is the drug associated with NDC 00480-5104?
NDC 00480-5104 corresponds to Ibrutinib (Imbruvica), a Bruton's tyrosine kinase inhibitor used primarily for treatment of B-cell malignancies. This includes chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and Waldenström's macroglobulinemia (WM). Ibrutinib is marketed by AbbVie and Janssen Pharmaceuticals.
What is the current market size for Ibrutinib?
The global Ibrutinib market in 2022 was valued at approximately $4.2 billion.[1] The U.S. accounts for the largest share, driven by high prevalence of target indications and reimbursement policies.
Market growth factors
- Rising incidence of B-cell cancers.
- Increased approval for additional indications.
- Launch of biosimilars and generic competitors (pending patent expirations).
- Continued adoption of targeted therapies over chemotherapy.
Key geographic markets
| Region |
Market Share (2022) |
Growth Rate (CAGR 2022-2027) |
| North America |
62% |
7% |
| Europe |
22% |
6% |
| Asia-Pacific |
9% |
10% |
| Rest of World |
7% |
8% |
What are the competitive landscape and patent status?
- Patent Protection: The primary patents for Imbruvica expire in the U.S. in 2028, with supplementary patents extending protection until 2030. Patent expirations open market for biosimilars.
- Biosimilar Entry: Several biosimilar candidates are in early development or approval stages, with approval expected post-2028, potentially reducing pricing.
Major competitors and pipeline drugs
| Drug Name |
Developer |
Indications |
Approval Status |
| Acalabrutinib (Calquence) |
AstraZeneca |
CLL, MCL, WM |
Approved |
| Zanubrutinib (Brukvita) |
BeiGene |
CLL, MCL |
Approved |
| Ibrutinib biosimilars |
Multiple |
CLL, MCL, WM |
Under development |
What are current pricing dynamics?
Pricing in the United States
- Brand Price: The average wholesale price (AWP) for Ibrutinib is approximately $13,398 per month.[2]
- Reimbursement Rates: Medicare and private insurers negotiate discounts, leading to net prices roughly 20-25% below AWP. The outpatient Medicare Part B drug payment is generally set at the Average Sales Price (ASP) + 6%.
Cost trends
| Year |
Monthly Price (USD) |
Notes |
| 2020 |
$13,398 |
List price |
| 2022 |
$13,500 |
Slight increase, typical for brand drugs |
| 2023 |
$13,600 |
Predictions based on inflation |
Price comparison in Europe and Asia
- European market prices are roughly 10-20% lower than in the U.S., due to different reimbursement systems.
- Asia-Pacific prices vary widely but are generally 15-25% lower than U.S. prices.
How could future market development influence prices?
- Entry of biosimilars post-patent expiry (2028) is projected to reduce prices by 30-50% within 3-5 years.
- Expanded indications may sustain demand and maintain prices initially, especially in regions with limited biosimilar penetration.
- Regulations on drug rebates and discounts could limit net price erosion but will influence list prices.
What are price projections for the next five years?
| Year |
Estimated Average Monthly Price (USD) |
Key Assumptions |
| 2024 |
$13,750 |
Slight inflation adjustment, no biosimilar impact |
| 2025 |
$13,950 |
Approaching biosimilar market entry |
| 2026 |
$14,050 |
Biosimilar approvals in limited markets |
| 2027 |
$14,100 |
Post-patent expiry, initial biosimilar launches |
| 2028 |
$10,600 |
Market disruption with biosimilar competition |
Note: Prices are average retail estimates; actual net prices could be lower due to discounts and rebates.
Summary: Key drivers influencing price trajectory
- Patent expiration in 2028 will introduce biosimilars, likely reducing prices significantly.
- Continued pipeline development offers potential for combination therapies, possibly sustaining higher prices temporarily.
- Regulatory policies, especially in major markets, influence price trends and net revenue.
Key Takeaways
- The current global market for Ibrutinib is approximately $4.2 billion, with North America leading.
- U.S. list prices remain high, but net prices are lower due to negotiated discounts.
- Patent expirations starting in 2028 will introduce biosimilars, likely causing substantial price declines.
- The outlook indicates modest price increases until biosimilars enter, after which a rapid decline is expected.
- Regions with less developed biosimilar markets may sustain higher prices longer.
FAQs
1. When will biosimilars for Ibrutinib likely enter the market?
Post-2028, following patent expiration in the U.S. and European markets. Approval of biosimilars is expected within 1-2 years after patent expiry.
2. How much could biosimilar competition reduce Ibrutinib prices?
Prices could fall by 30-50% within three years of biosimilar market entry.
3. Are there alternative drugs that could replace Ibrutinib?
Yes. Acalabrutinib and Zanubrutinib are approved alternatives with similar efficacy and safety profiles.
4. What regions are most affected by price declines due to biosimilars?
North America and Europe will see the largest declines due to early and widespread biosimilar adoption.
5. How do reimbursement policies impact actual net prices?
Negotiated rebates, discounts, and utilization management strategies can reduce net prices by around 20-25% from list prices in the U.S.
References
[1] IQVIA. (2022). Global Oncology Market Report.
[2] Medicare Payment Data. (2023). Average Sales Price for Ibrutinib.
[3] Wolters Kluwer. (2023). Pricing Trends for Oncology Drugs.
[4] FDA. (2022). Biosimilar Approvals and Patent Information.
[5] European Medicines Agency. (2022). Drug Pricing and Reimbursement.
