Drug maker loses lawsuit filed to regain ‘lost’ marketing time
The clock on marketing exclusivity can run even while a drug maker is awaiting clearance to sell a controlled substance, according to court ruling. The decision is a setback to Eisai, which claimed it unfairly lost valuable marketing time due to regulatory procedures. But a new bill winding its way through Congress could still override the decision.
Here’s the back story: In 2012, Eisai won FDA approval for two new drugs – the Belviq diet pill and the Fycompa epilepsy treatment – which triggered the beginning of a five-year marketing exclusivity period. This meant generic rivals could not sell lower-cost versions of either medication. But Eisai encountered launching delays because both drugs are controlled substances, which means they could not be marketed until the US DEA placed them on special lists for which distribution is restricted.