Paladin cleared to market oral contraceptive in Canada

Currently, Seasonale is marketed in the US where it was launched in October 2003 by Barr Laboratories’ subsidiary, Duramed Pharmaceuticals. In October 2005 Duramed granted Paladin an exclusive license to seek approval for and to market the drug in Canada.

Under the terms of the agreement, Duramed will manufacture Seasonale, which Paladin will market in Canada. Duramed will receive royalties and certain milestone payments as part of the deal. Paladin expects to launch the contraceptive in Canada in the fourth quarter of 2007.

The Seasonale regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year and requires women to take the pill for 84 consecutive days, with a seven day break. By contrast, the majority of oral contraceptive products currently available are based on a regimen of 21 treatment days, followed by seven days of placebo.