Last updated: February 27, 2026
What is NDC 46122-0696?
NDC 46122-0696 corresponds to Gilotrif (afatinib) tablets, indicated for the treatment of non-small cell lung cancer (NSCLC) with specific EGFR mutations. The drug is marketed by Boehringer Ingelheim and approved by the FDA.
Market Overview
Indications and Therapeutic Area
- Primary use: Treatment of metastatic NSCLC with activating EGFR mutations.
- Line of therapy: Approved as a first-line treatment.
- Market size: Global NSCLC market valued at approximately USD 11 billion in 2022, with targeted therapies representing a substantial segment.
Competitive Landscape
- Main competitors include Erlotinib (Tarceva), Osimertinib (Tagrisso), and Afatinib (Gilotrif).
- Afatinib's position: It holds a significant share in early-line EGFR mutation-positive NSCLC treatment, but faces market challenges from newer agents like osimertinib with superior efficacy and safety profiles.
Regulatory and Market Dynamics
- FDA approvals: First approved in 2013.
- Reimbursement: Widely reimbursed in developed markets; coverage varies by country.
- Market penetration: Approximately 40-50% in NSCLC EGFR mutation-positive populations in the US, with growth potential in emerging markets.
Price Analysis
Current Pricing
- Wholesale Acquisition Cost (WAC): Estimated USD 8,600 per 30-tablet bottle (60 mg dose).
- Monthly cost: Approximately USD 8,600 for a typical 30-day supply, assuming continuous daily use.
Pricing Trends
- Launch price in 2013 was around USD 8,000–USD 9,000 per month.
- Recently, pricing remains stable with minor fluctuations, reflecting competition and reimbursement negotiations.
Reimbursement and Market Access
- Insurance coverage in the US: Approximately 85% of insured patients have access to Gilotrif at negotiated rates.
- Patient assistance programs reduce out-of-pocket costs, influencing market penetration.
Price Projections (2023-2028)
| Year |
Predicted Average Wholesale Price (USD) |
Rationale |
| 2023 |
USD 8,600 |
Stable pricing, limited generic entry, consistent demand. |
| 2024 |
USD 8,500 |
Slight decrease due to increased negotiations and payor pressure. |
| 2025 |
USD 8,200 |
Potential for biosimilar or generic competition emergence. |
| 2026 |
USD 8,000 |
Greater generic market penetration, price reductions. |
| 2027 |
USD 7,800 |
Continued market share erosion with generics. |
| 2028 |
USD 7,500 |
Larger generic presence, further price declines. |
Future Market Drivers
- Introduction of biosimilars or generics could cut prices by 30-50%.
- Clinical advances or new indications could bolster demand.
- Evolving reimbursement policies and drug pricing regulations will influence achievable prices.
Key Takeaways
- Market size: The global NSCLC targeted therapy market exceeds USD 10 billion.
- Current pricing: Around USD 8,600 per month in the US.
- Competition: Afatinib faces competition from newer agents, impacting market share.
- Price trends: Expect marginal declines as generics or biosimilars enter the market.
- Growth factors: Increasing prevalence of NSCLC, expansion into emerging markets, and evolving treatment guidelines.
FAQs
Q1: When could generic versions of Gilotrif become available?
A1: Patent exclusivity typically lasts 12 years from approval, suggesting generics may enter the market around 2025-2026, depending on patent challenges and regulatory approvals.
Q2: How does Gilotrif compare to osimertinib in efficacy?
A2: Osimertinib has demonstrated superior progression-free survival and CNS penetration, potentially reducing Gilotrif's market share over time.
Q3: What markets present growth opportunities for Gilotrif?
A3: Emerging markets with increasing NSCLC incidence and expanding healthcare infrastructure offer growth, contingent on价格, reimbursement, and local approvals.
Q4: What are key factors influencing Gilotrif’s future pricing?
A4: Patent status, competitive dynamics, reimbursement policies, and clinical adoption rates.
Q5: Are there upcoming clinical trials that could affect Gilotrif’s market?
A5: Ongoing studies exploring combination therapies and new indications could extend its usage and maintain market relevance.
References
[1] IQVIA. (2022). Global Oncology Market Report.
[2] FDA. (2013). Gilotrif (afatinib) prescribing information.
[3] Evaluate Pharma. (2022). Global oncology forecasts.
[4] Boehringer Ingelheim. (2022). Gilotrif product details.
