Three years of indication-specific exclusivity for proving a new cancer use of an old drug

Paediatric exclusivity in the US and the EU's one-year data protection for a new indication of a well-established substance show that time-limited rewards can induce trials on old drugs. For oncology repurposing the reward is too weak to matter. The proposal is a three-year indication-specific exclusivity (marketing protection for the new oncology indication, with the drug remaining generic for existing uses) granted to any sponsor, including generic manufacturers and non-profits, that obtains approval of a new oncology indication for an off-patent drug on the basis of an adequately powered trial, with a price ceiling for the new indication tied to the trial cost.