The Lifecycle of a Rare-Disease Cancer Drug

Medicines are increasingly targeted at small patient populations and win orphan drug market protections; a trend labeled the “orphanization” of drugs.

The pharmaceutical industry says scientific developments have led to more targeted medicines, for example, those that hone in on a genetic mutation. This mutation might apply to several rare cancers, meaning they can test it and license it across several rare diseases, as Novartis did.

One pharma company’s medicine illustrates how firms can benefit from different layers of market-exclusivity protections.

Pharmaceutical company Novartis has earned $50.42 billion from its cancer drug Glivec since 2001, using a variety of market-exclusivity protections to shield the medication from the competition.

The chart below shows Glivec’s market progression. The drug was licensed for six different rare diseases, earning additional protections in each instance. By later withdrawing these protections, Novartis could also secure additional protections to reap back the lost market exclusivity while the drug was still in development and for testing in children.

Source: Politico