By demonstrating a new orphan indication for an existing therapeutic, you may be able to lengthen the period of exclusivity. By comparing the orphan approvals for both older and newer drugs, you can get a clearer picture of how viable this is as a business model.
• Target orphan drug indications to obtain extended periods of exclusivity for blockbuster therapeutics • Anticipate changes now that politicians and payers expect this • Weigh the prospect of changes to the orphan drug program, either legislatively or at the FDA level • Review orphan strategies to build value
