Teva Pharmaceutical Industries said yesterday that it would help Barr Pharmaceuticals to launch generic versions of Sanofi-Aventis’ antihistamine Allegra (fexofenadine hydrochloride).
The world’s largest generics company said it would lend its commercial muscle to Barr, even as it continues its long-running patent dispute with Sanofi-Aventis over the patent status of fexofenadine, which brought in revenues of 818 million euros in the first half of the year [[19/07/05c]].
Last week, Barr received US Food and Drug Administration (FDA) approval to market 30mg, 60mg and 180mg tablet formulations of fexofenadine hydrochloride, and is one of five companies taking on Sanofi-Aventis in the courts for the right to sell generic versions of the product [[15/07/05f]] [[15/04/05e]]. Barr is claiming first-to-file status for its products, which would make it eligible for 180 days’ marketing exclusivity under US law.
Under the terms of the agreement, Barr will pass its exclusive position on generic fexofenadine on to Teva to launch its own version during the exclusivity period, while Teva will pay Barr a percentage of the gross profit from its product.
The companies said the agreement will make it possible to launch the generics much earlier, although this strategy of course carries the risk that, should Sanofi-Aventis be successful in its legal action, they could be liable for significant damages. Last year, Barr and Teva were ruled to have not infringed three Allegra patents [[02/07/04d]], and earlier in 2005 overturned an additional patent on the drug. However, several patents remain in the litigation, and although no trial date has been set, the case is likely to reach the courts next year.