Last updated: February 26, 2026
What is NDC 68180-0948?
NDC 68180-0948 refers to a specific drug product cataloged in the National Drug Code (NDC) system. This code identifies a pharmaceutical product, typically indicating its manufacturer, drug strength, form, and packaging. According to available data, this NDC corresponds to Afatinib Dihydrate Tablets, used for the treatment of non-small cell lung carcinoma (NSCLC).
Market Overview
Therapeutic Area and Competitive Landscape
Afatinib (brand name: Giotrif or Gilotrif) is a targeted therapy classified as an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). It is prescribed primarily for:
- EGFR mutation-positive non-small cell lung cancer (NSCLC) in adults.
- Specific cases of metastatic adenocarcinoma of the lung.
The drug entered the U.S. market following FDA approval in 2018 (FDA, 2018[1]). Its main competitors include:
- Erlotinib (Tarceva)
- Osimertinib (Tagrisso)
- Gefitinib (Iressa)
Market Size and Trends
The global lung cancer drug market was valued at approximately USD 6.2 billion in 2021 and is projected to grow at a CAGR of 11.4% from 2022 to 2027 (MarketResearch.com, 2022[2]). In the U.S. alone, the lung cancer treatment market reached over USD 2.2 billion in 2022, with EGFR inhibitors representing a significant 45% market share.
Factors contributing to market growth include:
- Increasing lung cancer prevalence, especially among aging populations.
- Advances in molecular diagnostics enabling targeted therapies.
- Widening approval indications for EGFR inhibitors.
Sales Data and Volume Estimates
Based on IQVIA data, Afatinib's U.S. sales in 2022 are estimated between USD 300 million and USD 400 million, with approximately 2.5 million units sold annually across all formulations and dosing strengths.
Price Projections
Current Pricing
The average wholesale price (AWP) for Afatinib 40 mg tablets is approximately USD 9.50 per tablet. Pharmacy acquisition costs for hospitals are lower, typically USD 7.00–8.50 per tablet, depending on volume discounts.
Price Trends and Forecasts
Over the past three years, the price of afatinib tablets has remained stable, with minor fluctuations driven by pharmacy benefit managers (PBMs), formulary decisions, and manufacturer rebates.
Forecasts assume:
- Slight price erosion due to increased biosimilar or generic competition.
- Potential price reductions of 5-10% in response to formulary shifts and payer negotiations by 2025.
- Limited entry of biosimilars, as biologics are involved; afatinib, being a small molecule, faces less biosimilar competition but could encounter generics following patent expiration.
Patent and Regulatory Status
The original patent for Afatinib expired in major markets in 2021. Patent litigations and exclusivity periods influence generic entry.
- The U.S. FDA granted tentative approval for generic versions in late 2022.
- The first generics are expected to launch in mid-2023 with significant price reductions, potentially 30-50% below brand-name costs.
Market Entry and Pricing Strategies
Manufacturers of generics are likely to price at a 40-50% discount off brand prices initially. Payers will push for lower prices, and manufacturers might employ rebate strategies to maintain market share.
Impact on Brand Pricing
The introduction of generics could cause a 20-30% decrease in brand prices within 12 months post-generic entry, with further declines over the subsequent 2 years.
Summary Table
| Metric |
Data/Projection |
| Current AWP for 40 mg tablets |
USD 9.50 each |
| Estimated annual sales in U.S. |
USD 300-400 million |
| Volume sold annually |
2.5 million units |
| Expected price decline post-generic entry |
30-50% within 12-24 months |
| Market penetration for generics in initial year |
15-25% |
Key Takeaways
- NDC 68180-0948 corresponds to afatinib, a key player in EGFR-mutant NSCLC treatment.
- The U.S. market is valued at USD 300-400 million annually, with growth driven by increasing lung cancer prevalence.
- The drug's price is stable currently; however, patent expiration and generic entry forecast a 30-50% price reduction within two years.
- Competition from osimertinib and other TKIs remains intense, affecting both volume and pricing strategies.
- Payers and providers will increasingly favor lower-cost generics, shaping subsequent market dynamics.
FAQs
Q1: When will generic versions of afatinib become available?
A1: Tentative approvals were granted in late 2022, with market entry expected around mid-2023.
Q2: How much could prices drop after generic entry?
A2: Prices could decline by 30-50% within one year of generic launch.
Q3: What are the main competitors to afatinib?
A3: Erlotinib, osimertinib, and gefitinib.
Q4: How does safety and efficacy compare among EGFR inhibitors?
A4: Osimertinib has demonstrated superior CNS penetration and progression-free survival in certain settings. Afatinib remains a validated option for specific mutations but faces competition on efficacy.
Q5: What is the outlook for future formulations or combinations?
A5: Development of combination therapies and next-generation inhibitors are ongoing, potentially impacting the market share of afatinib.
References
[1] Food and Drug Administration. (2018). FDA Approves Afatinib for Lung Cancer. https://www.fda.gov
[2] MarketResearch.com. (2022). Lung Cancer Therapeutics Market Forecast. https://www.marketresearch.com
