{"entity":{"id":"idea-reg-new-indication-exclusivity-off-patent","kind":"idea","name":"Three years of indication-specific exclusivity for proving a new cancer use of an old drug","aka":[],"tldr":"Nobody funds trials of old drugs because competitors can sell the result for free. A short exclusive period for the new use, like the one given for children's studies, would change that.","summary":"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.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (No incentive to repurpose cheap drugs): Pantziarka et al., The Repurposing Drugs in Oncology (ReDO) Project (ecancer 2014)","url":"https://doi.org/10.3332/ecancer.2014.442"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-generic-repurposing","b-incentive-misalignment"],"keyPapers":["paper-pantziarka-ecancermedicalscience"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"The reward induces at least ten new registered phase 3 oncology trials of off-patent drugs within five years, sponsored by generic companies or non-profits, without materially raising prices for existing uses.","rationale":"Generic manufacturers have the manufacturing and regulatory capacity to sponsor trials but no way to recoup the cost; a modest, indication-limited exclusivity is a more targeted incentive than transferable vouchers and has precedent in paediatric legislation.","test":"Legislate the reward in one jurisdiction and count new repurposing trial registrations with generic or non-profit sponsors against the prior five years.","maturity":"speculative","actor":"policy","cost":"small","horizonYears":5},"route":"/ideas/idea-reg-new-indication-exclusivity-off-patent/","neighbours":{"bottleneck":[{"id":"b-incentive-misalignment","kind":"bottleneck","name":"Incentives reward me-too drugs and marginal gains","route":"/bottlenecks/b-incentive-misalignment/"},{"id":"b-generic-repurposing","kind":"bottleneck","name":"No incentive to repurpose cheap drugs","route":"/bottlenecks/b-generic-repurposing/"}],"paper":[{"id":"paper-pantziarka-ecancermedicalscience","kind":"paper","name":"The Repurposing Drugs in Oncology (ReDO) Project","route":"/key-papers/paper-pantziarka-ecancermedicalscience/"}]}}