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

Source: https://onco.cc/ideas/idea-reg-new-indication-exclusivity-off-patent/  
OnCo record `idea-reg-new-indication-exclusivity-off-patent` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed 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

## Sources

- Bottleneck evidence (No incentive to repurpose cheap drugs): Pantziarka et al., The Repurposing Drugs in Oncology (ReDO) Project (ecancer 2014): https://doi.org/10.3332/ecancer.2014.442

## Connected records

- bottlenecks: [Incentives reward me-too drugs and marginal gains](https://onco.cc/bottlenecks/b-incentive-misalignment/), [No incentive to repurpose cheap drugs](https://onco.cc/bottlenecks/b-generic-repurposing/)
- key papers: [The Repurposing Drugs in Oncology (ReDO) Project](https://onco.cc/key-papers/paper-pantziarka-ecancermedicalscience/)

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