Report sees legislation limiting indication expansion

New regulations could limit the use of patented drugs in the treatment of illnesses they were not originally designed for, otherwise known as indication expansion.

A report from Datamonitor claims that regulatory changes in the US and in Europe could inhibit use of the marketing technique, used by pharmaceutical companies to keep generic firms at bay and maintain profits. The moves will reduce the ability of drugs companies from filing for new indications within the EU.

Whilst new EU legislation could offer “the potential to gain an additional one-year market exclusivity for new indications filed during the first eight years on market”, it also will include “a provision for generics companies to exclude patented indications or dosage forms from their product information”, analyst Adele Schulz said.

Meanwhile, the US’s Medicare Modernization Act (MMA) of 2003 removed the ability for pharmaceutical firms to benefit from multiple 30-day delays in generic approval, leaving firms with only one 30-day delay set when an original drugs maker sues a generic manufacturer.

Ms Schulz added that “recent high-profile drug safety concerns” such as those surrounding Vioxx and SSRIs are threatening “to reduce the potential for companies to profit from off-label use of their products”.

Datamonitor found that as many as 84 per cent of the 50 top drug brands in the US have had new indications since their original launch.

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