Last updated: February 23, 2026
What is NDC 60429-0495?
NDC 60429-0495 corresponds to the drug Gilotrif (afatinib) 20 mg, a tyrosine kinase inhibitor approved for treatment of epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). It was approved by the FDA in July 2018. The drug is marketed by Boehringer Ingelheim.
Market Size and Demand Trends
Current Market Landscape
- Market Adoption: Gilotrif faces competition from targeted therapies like Erlotinib, Gefitinib, and Osimertinib.
- Prevalence of EGFR-positive NSCLC: Estimated at 20-30% of NSCLC cases globally.
- Annual Incidence of NSCLC: Approximately 2.2 million cases worldwide (2020 data).
Sales Data and Revenue
- U.S. Sales (2022): Approximately $250 million, reflecting moderate penetration.
- Global Sales (2022): Estimated at $400 million, with growth driven by expanding indications and market penetration.
Market Drivers
- Increased testing for EGFR mutations.
- Rising NSCLC incidence in aging populations.
- Approval of combination therapies and new indications.
Market Challenges
- Competition from third-generation EGFR inhibitors (e.g., Osimertinib).
- Patent protection and exclusivity periods.
- Pricing pressures from healthcare systems and payers.
Price Analysis of NDC 60429-0495
Current Pricing
- Average Wholesale Price (AWP): Around $4.50 per 20 mg tablet.
- Procurement Cost: Estimated at 10-15% below AWP for institutional purchasers.
- Average Wholesale Price per Course: Approximately $3,600 for a standard 30-day supply.
Price Trends
- Pre-approval (2018): Launch price was approximately $7,000 per month.
- Post-approval: Prices stabilized around $4,500-$5,000 per month.
- Reimbursement Rates: Often lower for managed care plans, influencing actual net prices.
Price Projections (Next 3–5 Years)
| Year |
Estimated Price per Month |
Notes |
| 2023 |
$4,200–$4,500 |
Stable due to market saturation |
| 2024 |
$4,000–$4,300 |
Competition impacts pricing |
| 2025 |
$3,800–$4,000 |
Entry of generics possible (~2025) |
| 2026 |
$3,500–$3,800 |
Potential generic competition |
Impact of Generics
- Patent Expiry: Predicted around 2025-2026.
- Generic Entry: Likely reduces prices by 50% or more.
Regulatory and Policy Influences
- Pricing Regulations: Increasing scrutiny in the U.S. and Europe could pressure pricing.
- Insurance Coverage: Payer negotiations influence net prices.
- Expanded Indications: May increase demand, supporting stable pricing.
Competitive Landscape
- Key Competitors:
- Osimertinib (Tagrisso): $10,000+ per month.
- Gefitinib (Iressa): Differing pricing, with discounts.
- Erlotinib (Tarceva): Boosts market dynamics but lower efficacy in resistant cases.
Average market share for Gilotrif remains below 10% in the EGFR inhibitor segment but is expanding with new indications.
Strategic Outlook
- Market Penetration: Focus on regions with higher NSCLC incidence and testing rates.
- Pricing Strategy: Maintaining premium pricing in early stages; preparing for shifts with potential generics.
- Market Expansion: Potential for new indications or combination therapies to sustain growth.
Key Takeaways
- Gilotrif's market has matured since 2018, with stable but competitive pricing.
- Growth hinges on increased diagnostic screening, therapeutic advancements, and market penetration.
- Price reductions are expected with upcoming patent expirations and generic competition around 2025–2026.
- Pricing pressures from payers and regulatory bodies will influence future profit margins.
- The competitive landscape favors drugs with demonstrated efficacy and combination potential, impacting Gilotrif's market share.
FAQs
1. What factors influence Gilotrif's market sales?
Changes in EGFR mutation testing rates, competition from newer drugs, patent status, and healthcare policy shifts.
2. How does Gilotrif compare in price to its competitors?
It is generally priced lower than third-generation EGFR inhibitors like Osimertinib but higher than older therapies such as Erlotinib and Gefitinib.
3. When are generics expected to enter the market?
Approximately 2025–2026, contingent on patent challenges and regulatory approvals.
4. What regions show the most growth potential?
Asia-Pacific countries with high NSCLC prevalence, owing to expanding testing and treatment access.
5. How will new indications impact the market?
Possible approvals for other cancers or combination therapies could increase demand but may also introduce competitive pricing pressures.
References
[1] FDA. (2018). FDA approves Gilotrif for non-small cell lung cancer. U.S. Food and Drug Administration.
[2] IQVIA. (2022). National Drug Data File.
[3] Global Data. (2023). EGFR-positive NSCLC market analysis.
[4] Boehringer Ingelheim. (2021). Gilotrif (afatinib) prescribing information.
[5] IMS Health. (2023). Worldwide oncology drug sales report.
