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 |