Orphan Drug

Orphan drugs are those used to treat rare medical conditions. Their production is unprofitable unless government assistance exists. Zydus Cadila’s Saroglitazar Mg, which is used for treating the liver disease Primary Biliary Cholangitis (PBC), received orphan drug designation from the US FDA.  Such designated drugs are eligible for certain development incentives like tax credits for qualified clinical testing, prescription drug user fee exemption and 7-year marketing exclusivity.