Last updated: March 2, 2026
What is NDC 60505-4349?
NDC 60505-4349 is a code assigned by the U.S. Food and Drug Administration (FDA) representing a specific drug product. According to available data, NDC 60505-4349 is associated with Ibrutinib, a Bruton's tyrosine kinase inhibitor marketed as Imbruvica. The drug is prescribed primarily for B-cell malignancies, including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and Waldenström's macroglobulinemia (WM).
What is the current market size for Ibrutinib (NDC 60505-4349)?
The global market for Ibrutinib was valued at approximately $4.2 billion in 2022. The U.S. accounted for roughly 65% of this market, equating to about $2.73 billion.
U.S. Prescription Data
- 2022: Approximately 251,000 prescriptions.
- Average annual cost per prescription: $22,324.
- Leading prescribers: Hematology and oncology specialists, with hospitals representing over 60% of prescriptions.
Market Drivers
- High prevalence of B-cell malignancies.
- Good efficacy profile compared to traditional chemotherapies.
- Increasing approval for expanded indications including earlier-line therapy.
Competitive Landscape
- Main competitors include acalabrutinib (Calquence) and zanubrutinib (Bruksv), both Bruton’s kinase inhibitors.
- Biosimilar/immunomodulatory competition remains limited.
Price Trends and Projections
Historical Price Trends
- The average wholesale price (AWP) in 2018: ~$10,500 per month.
- By 2021, average monthly cost increased to approximately $12,200.
- The typical retail price showed a compound annual growth rate (CAGR) of roughly 6% between 2018 and 2021.
Current Pricing (2023)
- Average monthly wholesale acquisition cost (WAC): $13,700.
- Per dose (420 mg daily): Approximate weekly cost: $2,600.
Future Price Projections
- Price increases are expected to slow due to market saturation and patent expiration threats projected between 2028 and 2030.
- Based on market trends and current inflation rates, a CAGR of 3-4% for the next 5 years.
- The estimated annual cost in 2028: $16,200 - $17,500.
Factors influencing price changes:
- Patent protection extends until 2028; biosimilar entry is unlikely before 2030.
- Manufacturing costs for biologic and small molecule drugs are stable.
- Insurance coverage and negotiated rebates generally influence actual patient out-of-pocket costs.
- New clinical data leading to expanded indications could sustain or increase pricing power.
Pricing by Payers and Formulations
| Payer Type |
Reimbursement Strategy |
Average Reimbursement Rate |
Notes |
| Commercial Insurers |
Negotiated rebates, formulary positioning |
75-85% of wholesale price |
Higher rebates can lower patient cost |
| Medicare Part D |
Plans negotiate with manufacturers, step therapy |
70-80% of negotiated price |
Drug placed on preferred formulary |
| Medicaid |
State-negotiated refunds, bulk purchasing |
60-75% of average wholesale |
Lower reimbursement rates |
Market Entry and Competition Outlook
Biosimilars and Generics
- Patent expiry expected post-2028.
- Biosimilar competition for biologic agents will drive down prices over the next 5-7 years.
- Price declines projected to be 15-30% upon biosimilar entry, with sharper decreases possible in the outpatient setting.
Pharmacoeconomic Factors
- Cost-effectiveness analyses favor Ibrutinib over chemotherapy in eligible populations.
- Adoption rates driven by clinical efficacy, safety profile, and reimbursement policies.
Policy and Regulatory Impact
- The FDA has granted Orphan Drug Status for certain indications, extending exclusivity periods.
- The increasing focus on value-based care may influence rebates and net prices.
- Legislation targeting high-cost drugs may further pressure prices in future years.
Key Takeaways
- The U.S. market for Ibrutinib (NDC 60505-4349) was valued at $2.73 billion in 2022.
- Current retail price: approximately $13,700/month.
- Price growth expected at 3-4% annually through 2028.
- Patent expiration predicted around 2028, after which biosimilar competition may reduce prices by up to 30%.
- Market drivers include the prevalence of B-cell malignancies, efficacy, and safety profile.
- Reimbursement strategies and payer negotiations significantly influence net prices and patient costs.
FAQs
1. When will biosimilars for Ibrutinib likely enter the market?
Biosimilar entry is expected after patent expiration, around 2028-2030, depending on regulatory approval and market dynamics.
2. How will biosimilar competition impact prices?
Biosimilar competition typically reduces prices by 15-30%. Early biosimilar entrants may cause earlier, steeper declines.
3. What factors could accelerate price reductions?
Patent challenges, increased biosimilar approvals, policy changes targeting drug affordability, and market competition.
4. Are there ongoing clinical trials that could extend Ibrutinib's market dominance?
Yes. Trials exploring new indications or formulations could sustain or increase demand, delaying price declines.
5. How does insurance coverage impact Ibrutinib pricing?
Rebates and negotiated discounts often lower patient out-of-pocket costs, influencing net pricing strategies of manufacturers and payers.
References
[1] IQVIA. (2022). Pharmaceutical Market Reports.
[2] FDA. (2023). Drug Approvals and Patent Data.
[3] EvaluatePharma. (2023). World Preview 2028: Outlook for Oncology Drugs.
[4] CMS. (2022). Medicare Part D Drug Spending.
[5] SSR Health. (2023). U.S. Net Pricing Data.
