Last updated: February 15, 2026
What is the drug associated with NDC 46122-0434?
NDC 46122-0434 corresponds to Brigatinib (Alunbrig), a kinase inhibitor used in the treatment of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Approved by the FDA in April 2017, Brigatinib is marketed by Takeda Pharmaceuticals.
What is the current market landscape for Brigatinib?
Market Size & Demand
- The global ALK-positive NSCLC market was valued at approximately USD 475 million in 2021.
- The U.S. accounts for roughly 40% of global sales, driven by higher diagnosis rates and access.
- Incidence of ALK-positive NSCLC in the U.S. estimated at 3-7% of all lung cancers, translating to around 10,000 new cases annually.
Competitive Environment
- Brigatinib faces competition from first-generation ALK inhibitors like Crizotinib and second-generation options such as Alectinib and Ceritinib.
- Recently approved third-generation ALK inhibitors like Lorlatinib aim to address resistance issues.
Market Drivers
- Increasing awareness and testing for ALK mutations.
- Growing adoption of targeted therapies based on molecular profiling.
- Expansion of indications to include CNS metastases, common in ALK-positive cases.
Market Challenges
- High drug costs and reimbursement hurdles.
- Resistance development leading to treatment discontinuation.
- Competition from emerging therapies and potential biosimilars.
What are the pricing trends for Brigatinib?
Current Pricing (as of Q1 2023)
- Wholesale Acquisition Cost (WAC): approximately USD 12,000 per month for the branded drug.
- Estimated annual treatment cost: USD 144,000 per patient.
Price Trends
- Initial launch price in 2017: around USD 12,000/month.
- Stable pricing with slight adjustments for inflation and payer negotiations.
- Price increases largely driven by inflation adjustments rather than major hikes.
Comparison with Competitors
| Drug |
Monthly Cost |
Indication |
Approval Year |
| Brigatinib |
USD 12,000 |
ALK-positive NSCLC |
2017 |
| Alectinib |
USD 12,217 |
ALK-positive NSCLC |
2015 |
| Lorlatinib |
USD 13,890 |
ALK-positive NSCLC |
2018 |
Note: These prices are estimates based on wholesale acquisition costs; actual transaction prices vary by payer negotiations.
What are the future price projections?
Factors Influencing Future Prices
- Patent exclusivity expires in 2029, possibly leading to biosimilar entry.
- Biosimilar pricing is expected to be 20-40% lower than branded prices.
- Increasing volume sales due to broader testing and earlier diagnosis.
- Pricing adjustments aligned with inflation rates and healthcare policy changes.
Projection Outlook (2023 – 2030)
| Year |
Expected Price Range (USD/month) |
Rationale |
| 2023 |
USD 12,000 - USD 13,000 |
Stable with minor inflation adjustments. |
| 2025 |
USD 11,500 - USD 12,500 |
Slight downward pressure due to payer negotiations and initial biosimilar entries. |
| 2030 |
USD 10,000 - USD 11,000 |
Potential biosimilar market penetration and increased competition. |
What is the outlook for revenue and market share?
- Revenue forecasts suggest steady growth driven by increased diagnosis; projected global sales could reach USD 600 million by 2025.
- Market share stabilizes around 70-75%, with new entrants attempting to capture a portion of the market.
- Patent expiration in 2029 is likely to accelerate pricing reductions.
Closing Summary
Brigatinib remains a key player in the ALK inhibitor segment, with stable pricing near USD 12,000 per month. Market growth is driven by increasing diagnosis rates, despite competition and resistance issues. Patent expiration prospects may significantly impact pricing and market share in the next decade.
Key Takeaways
- NDC 46122-0434 (Brigatinib) has a consistent market position but faces upcoming biosimilar competition.
- Current U.S. drug pricing averages USD 12,000/month; global sales are approximately USD 475 million/year.
- Market expansion relies on increasing molecular testing and broader indication approvals.
- Future pricing likely to decline post-patent expiry, with biosimilars potentially reducing costs by 20-40%.
- Revenue growth will depend on diagnostic advances and competitive dynamics.
FAQs
1. When will the patent for Brigatinib expire?
Patent protection is expected to last until 2029, opening the market to biosimilars or generics thereafter.
2. Are biosimilars for Brigatinib available yet?
As of early 2023, no biosimilars have been approved; they are anticipated post-2029.
3. How does Brigatinib compare in price to other ALK inhibitors?
Brigatinib's monthly cost (~USD 12,000) aligns with similar second-generation ALK inhibitors like Alectinib; Lorlatinib is slightly more expensive.
4. What factors may influence future pricing?
Patent expiration, biosimilar competition, healthcare policy changes, and negotiated discounts all impact future prices.
5. What is the primary market driver for Brigatinib’s growth?
Increased molecular testing and approval expansion for CNS metastases are key drivers.
References
[1] IQVIA, "Market Data Reports," 2022.
[2] U.S. Food and Drug Administration, "FDA Approval History," 2017.
[3] Clinical trials and prescribing information for Brigatinib, 2022.
[4] Evaluate Pharma, "2023 Global Oncology Insights," 2022.
