Israel’s Teva Pharmaceutical Industries has won US approval for a generic version of Sanofi-Aventis’ oral antidiabetes drug Amaryl (glimepiride) 1mg, 2mg and 4mg tablets.

The company has been granted a tentative approval – subject to the expiry of patent protection of these formulations in the USA. Final approval will be granted once Sanofi-Aventis’ US intellectual property expires on October 6, 2005. Amaryl, which helps control blood glucose levels in patients with type 2 diabetes, has annual sales in the US of approximately $340 million dollars.

As Teva is awaiting expiry of the patent before it launches its glimepiride tablets – and launch is not dependent on the outcome of a patent dispute – analysts said the approval has already been factored into their earnings calculations for the firm, which is currently playing leapfrog for the top spot in the generics market with Novartis subsidiary Sandoz [[03/08/04d]]. Other companies are likely to receive tentative approval for glimepiride formulations in the build-up to the patent expiry.

Earlier this week, Teva was rumoured to be planning a bid for German generics house Stada, something the latter company has dismissed as fantasy [[28/06/05g]].