Analyst considers impact that loss of US Accutane patent will have on Roche

On February 7, a key US patent on Roche's acne treatment Accutane(isotretinoin) expires. With sales of about $700 million a year, the product is the third-largest in the Swiss company's portfolio and it might be expected that the onset of generic competition would have a profound impact on its performance. However, Roche maintains that Accutane sales will only start a slow decline once US protection is lost and generics enter the market, even though it has not been unusual for successful drugs to lose 75% of their sales within two years of US patent expiration.

Accutane has enjoyed considerable success because, for patients with the most severe forms of acne, it has little competition. 60% of its sales are booked in the USA, and it accounted for 8% of Roche's total pharmaceutical turnover in 2000, according to Julius Baer analyst Denise Anderson in a report on the drug. A generic version of the drug, Douglas Pharmaceuticals' Oratane, is already on the market in Australia, New Zealand, Asia and certain Middle East and European Union countries.

Barriers to generics?