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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

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Globalization and Health

ISSN: 1744-8603