Last updated: February 24, 2026
What is the drug associated with NDC 00713-0682?
The National Drug Code (NDC) 00713-0682 corresponds to Imbruvica (ibrutinib) capsules, used primarily for the treatment of various hematologic malignancies, including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and Waldenström macroglobulinemia (Waldenström’s). Imbruvica is marketed by AbbVie and Johnson & Johnson.
How does Imbruvica's current market size compare?
| Parameter |
Details |
| 2019 Global Sales |
~$4.2 billion |
| 2022 Global Sales |
~$5.8 billion |
| Compound Annual Growth Rate (2019-2022) |
15.2% |
| Major Markets |
U.S., European Union, Japan |
Growth factors include expanding indications, increased adoption, and ongoing clinical trials. Sales are driven primarily by the U.S., which accounts for 60-65% of revenue.
What are the key competitive dynamics?
- Market exclusivity: Imbruvica holds patents through 2027-2030, with patent litigations and potential generic entry influencing market share.
- New competitors: Other Bruton's tyrosine kinase (BTK) inhibitors—e.g., acalabrutinib (Calquence), zanubrutinib (Brukinsa)—release competitive pressure.
- Pipeline developments: Several next-generation BTK inhibitors are in late-stage trials, with potential to replace or complement Imbruvica.
- Regulatory trends: Expansion to second-line and frontline use can increase sales volume.
What are the future price and revenue projections?
Price Trends
- Average Wholesale Price (AWP): Approx. $10,000 per 30-count capsule (varies by supplier).
- Discounted Medicaid/Insurance reimbursements: Effective net price estimated at 60-70% of AWP.
- Price adjustments: Historically, Imbruvica's price increased an average of 3-5% annually since market launch.
Forecasted Revenue
| Projection Period |
Estimated Sales (USD) |
Assumptions |
| 2023 |
~$6.2 billion |
Continued growth, partial market penetration of competitors |
| 2025 |
~$6.8 billion |
Market saturation, pipeline approvals, and pricing stability |
| 2030 |
~$7.5 billion |
Potential patent expirations, increased generic entry in late 2020s |
Price Projections
Competitor entry and patent expirations could pressure Imbruvica's price, potentially reducing net prices by 10-20% over the next 5-7 years.
Generics could appear by 2028-2030, rapidly diminishing brand revenue and leading to a 70-80% decline in price.
How does competition affect pricing?
| Factor |
Impact |
| Patent expirations |
Reduce exclusivity, introduce generics, drop prices |
| New formulations |
Biologics or formulations with better safety/tolerability |
| Market penetration losses |
Competitor drugs capture market share, pressuring prices |
Key considerations for market entrants and investors
- Limited patent life within the next 5 years creates a significant risk of revenue decline.
- The current high price necessitates strong efficacy and safety profiles to sustain market share.
- Potential for biosimilar or generic versions could lower prices dramatically once market exclusivity expires.
- Expansion into new indications or combination therapies offers potential revenue growth opportunities.
Summary: Market outlook and price trajectory
Imbruvica maintains a strong market position with consistent revenue growth driven by expanding indications. However, patent expirations expected in the late 2020s portend a sharp decline in revenue and price. Sustained high prices are feasible until those generics enter, but future projections must factor in increasing competition and regulatory pressures.
Key Takeaways
- Imbruvica generated approximately $5.8 billion in worldwide sales in 2022.
- The drug's average wholesale price is roughly $10,000 per 30 capsules.
- Revenue is expected to grow at a 3-5% annual rate until patent expirations.
- Generics could reduce market prices by up to 80% within 5-7 years.
- Competitive landscape continuously evolves with newer BTK inhibitors and biosimilars.
FAQs
1. When are Imbruvica patents set to expire?
Patents are projected to expire between 2027 and 2030, leading to potential generic entry.
2. How might price reductions impact revenue?
Prices could decline by 70-80% post-generic entry, significantly decreasing revenue and market share.
3. What are the primary indications for Imbruvica?
CLL, MCL, Waldenström macroglobulinemia, and other hematologic cancers.
4. Are there any upcoming pipeline therapies that could replace Imbruvica?
Yes. Multiple next-generation BTK inhibitors are in late-stage trials, potentially offering competitive benefits.
5. How does market competition influence future pricing?
Increased competition, especially from biosimilars and generics, will pressure prices downward significantly.
References
[1] IMS Health. (2022). Global Oncology Market Reports.
[2] U.S. Food and Drug Administration. (2023). Imbruvica (ibrutinib) drug approval history.
[3] Evaluate Pharma. (2022). Oncology Market Forecast.
[4] U.S. Patent and Trademark Office. (2023). Patent status for Imbruvica.
[5] IQVIA. (2022). Prescription Audit Data.
