Skip to main content

Table 1 Data Sources

From: A multidisciplinary review of the policy, intellectual property rights, and international trade environment for access and affordability to essential cancer medications

Data Source Selection criteria based on listing on EML Information Collected
Orange Book (FDA) Generic drug name, formulation and dose, approved indication Patent and exclusivity information
Purple Book (FDA) Reference Product Exclusivity Expiry Date (if available), Biosimilar approval; else, search in the literature
Orphan Drug Database (FDA) If the drug has an orphan designation (“Designated”) and if it received “Approval” to market as an orphan drug