Last updated: February 25, 2026
What Is the Drug Identified by NDC 67877-0454?
The National Drug Code (NDC) 67877-0454 corresponds to Brigatinib, marketed as Alunbrig. It is an oral tyrosine kinase inhibitor used primarily for the treatment of ALK-positive non-small cell lung cancer (NSCLC) in adult patients. The drug was approved by the FDA in April 2017.
Current Market Position
Brigatinib holds a niche in the targeted oncology segment, with competition primarily from:
- Crizotinib (Xalkori)
- Alectinib (Alecensa)
- Lorlatinib (Lorbrena)
As of 2023, Brigatinib's annual sales approximate $250 million, with sales growth slightly outpacing competitors due to its efficacy in resistant ALK-positive NSCLC cases.
Market Size and Growth Trends
Oncology Target Segment
The global NSCLC market was valued at $15.2 billion in 2022, with targeted therapies constituting 65% of that market share. The segment is projected to grow at a compound annual growth rate (CAGR) of 7% through 2030, driven by increased precision medicine adoption and expanding patient populations.
Incidence and Prevalence
In the US, approximately 236,000 new lung cancer cases are diagnosed annually, with about 3-5% testing positive for ALK rearrangements. This equates to roughly 7,000 to 12,000 new ALK-positive NSCLC cases annually. The global prevalence is estimated at 0.5-1.0% of all lung cancers, translating to an international market potential of $100-$200 million for targeted therapies, excluding off-label and combination use.
Price Structure Analysis
Current Pricing
- List Price: Approximate wholesale acquisition cost (WAC) per 30-day supply in the US is $12,000.
- Net Price: Estimated at $8,000-$10,000, factoring in discounts, rebates, and negotiations.
- Cost per Treatment Course: Typically about $96,000 annually.
Competitive Pricing Comparison
| Drug |
List Price (per 30-day supply) |
Indication |
Approval Year |
Market Share (2023) |
| Brigatinib |
$12,000 |
ALK-positive NSCLC |
2017 |
25% |
| Alectinib |
$13,500 |
ALK-positive NSCLC |
2015 |
35% |
| Lorlatinib |
$13,000 |
ALK-positive NSCLC |
2018 |
20% |
Brigatinib's price is competitive but marginally lower than its primary competitors, supported by biosimilar threats and payer negotiations.
Price Projections (2024–2030)
Forecast Assumptions
- Steady volume growth aligned with incidence trends.
- Market penetration increases as earlier detection and testing expand.
- Price erosion from biosimilar and generic entry after patent expiry in 2027.
- Potential for tiered pricing in emerging markets.
Projected Trends
| Year |
Estimated Market Share |
Wholesale Price (per 30 days) |
Annual Revenue (approximate) |
| 2024 |
28% |
$11,500 |
$290 million |
| 2025 |
30% |
$11,000 |
$330 million |
| 2026 |
32% |
$10,500 |
$370 million |
| 2027 |
25% (post-patent expiry) |
$9,000 |
$270 million |
| 2028 |
20% |
$8,500 |
$200 million |
Note: The decline post-2027 accounts for biosimilar and generic competition, as well as increased affordability initiatives.
Regulatory and Patent Landscape
- Patent Expiry: Expected 2027, with patent protections covering the formulation and manufacturing processes.
- Generic/Biosimilar Approvals: First biosimilars targeted for launch no earlier than 2027.
- Regulatory Developments: Expansion to Europe and Asia-Pacific anticipated, potentially boosting volume.
Strategic Considerations
- Investing in value-based price negotiations can sustain margins amidst patent cliff.
- Expanding dosing regimens or combination therapies offers diversification.
- Aligning with emerging biosimilar entrants will be critical for maintaining market share.
Key Takeaways
- Brigatinib's market is small but growing, with annual sales around $250 million.
- Price per course ranges from $96,000 to $120,000; competition slightly influences pricing.
- Revenue growth depends on clinical adoption and early diagnosis trends.
- Patent expiry in 2027 introduces significant biosimilar competition, likely causing price erosion.
- Market expansion into international regions presents upside but involves regulatory challenges.
FAQs
1. How does Brigatinib compare in efficacy to other ALK inhibitors?
It demonstrates comparable or superior progression-free survival in resistant cases, with a favorable side-effect profile. Regulatory approvals reflect its clinical utility.
2. What are the key factors influencing Brigatinib’s pricing?
Market acceptance, competition, payer negotiations, and patent protection play substantial roles.
3. When will biosimilar versions likely impact prices?
Post-2027, following patent expiration and regulatory approval.
4. What is the potential for price reductions in emerging markets?
Significant, driven by economies of scale, patent expiration, and local pricing policies.
5. How might new indications influence market growth?
Expansion into earlier lines of therapy or combination regimens could increase sales volume and justify higher prices initially.
References
[1] FDA. (2017). Alunbrig (brigatinib) approval letter. Retrieved from https://www.fda.gov
[2] IQVIA. (2023). Pharmaceutical Market Data.
[3] EvaluatePharma. (2022). Global Oncology Market Forecast.
[4] Centers for Disease Control and Prevention. (2022). Lung Cancer Statistics.
[5] Medicare & Medicaid Services. (2023). Drug Pricing Trends.
