Sanofi-Aventis gets competition from Teva and Barr Allegra generics deal

US firm Barr Pharmaceuticals and Teva Pharmaceutical Industries of Israel say that they have entered into an agreement for the launch of fexofenadine hydrochloride 30mg, 60mg and 180mg tablets, the generic versions of Sanofi-Aventis' Allegra, which had annual sales of approximately $1.4 billion, based on IMS Health data for the 12 months ended June 2005.

Under the agreement, Barr has taken the regulatory steps necessary to permit Teva to obtain final US Food and Drug Administration approval of its fexofenadine and to sell the product within the US firm's 180-day exclusivity. In return, Barr will receive a negotiated percentage of the gross profit of Teva's product, both during and after the exclusivity period. Teva will record the revenues resulting from sales of the product and remit the negotiated percentage of its gross profit to Barr.

Although Barr and Teva have been granted summary judgment of non-infringement with respect to three patents, several others remain in litigation. No trial date has been set, but the firms expect this to occur sometime in 2006. Their announcement that they will start shipping generic versions of Allegra immediately could put the companies at risk of paying compensation to Sanofi-Aventis if the court subsequently rules against them.