Market Exclusivity for Drugs with Multiple Orphan Approvals (1983-2017) and Associated Budget Impact in the US.
William V PadulaSonal ParasrampuriaMariana P SocalRena M ContiGerard F AndersonPublished in: PharmacoEconomics (2021)
Multiple blockbuster drugs have received exclusivity of > 10 years through the Orphan Drug Act, thereby delaying rare disease cohorts' access to generic/biosimilar equivalents.