First new drug in a decade approved in Europe as Viagra patent expires

The first new drug for male erectile dysfunction (ED) in over 10 years has been approved in Europe. Spedra (avanafil) aims to compete for a share of the lucrative ED market, trading on the fact that it is much faster-acting than other available drugs.

The drug has been approved in the US since September 2011, but the company that produces it, Vivus, has yet to find a suitable partner to market and distribute it.

Stiff competition

Meanwhile, generic drug manufacturers are jostling for a share of the European market for sildenafil (Viagra), now that Pfizer’s patent on the drug has expired. Among the first to launch their competitor versions are Teva and Actavis.

Both companies had already brought their drugs to market in countries not covered by the Pfizer patents, or where the patents had been overturned already (Actavis in Bulgaria, Iceland and Malta; Teva in Spain and Canada among others).

Sales of sildenafil brought Pfizer over $2 billion in revenue in 2012. The company will enjoy extended patent protection in the US (its biggest market for Viagra) for a while longer, competition in Europe will likely lead to deflated sales.

‘Female Viagra’ revived

While male ED is an established market, treatments for female sexual dysfunction have been significantly more controversial. However, Sprout Pharmaceuticals has reapplied to the US Food and Drug Administration for approval for flibanserin.

The drug is aimed at treating pre-menopausal women with hypoactive sexual desire disorder, and the resubmission follows positive results in a recent Phase III clinical trial. The company believes the trial results provide answers to concerns raised in Boehringer–Ingelheim’s previous application, which was refused in 2010.