Afatinib Dimaleate



  1. Marketed by Boehringer Ingelheim Pharmaceuticals, Inc
  2. Orally bioavailable anilino-quinazoline derivative and inhibitor of the receptor tyrosine kinase (RTK) epidermal growth factor receptor (ErbB; EGFR) family
  3. First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations


  1. First U.S. approval: July 12, 2013
  2. First E.U. approval: September 25, 2013

Constraint date forecast:

  1. Patent expiry: 2026 (United States)
  2. SPC expiry: 2026 (European Union)
  3. Patent expiry: 2026 (Japan)

API availability

Source: Cortellis Generics Intelligence

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