Canadian generics company, Biovail Corporation, says that it has won tentative approval from the US Food and Drug Administration for its orally disintegrating version of Sanofi-Aventis’ sleep drug, Ambien (zolpidem).

Full clearance cannot be given until the French company’s patent on the branded drug expires in October 2006.

Biovail expects its version of the drug will be advantageous, particularly for patients who have difficulty swallowing tablets, or those who may not always have access to water. Studies in the US have indicated that up to 40% of adults have experienced problems with swallowing tablets, the firm added.

Biovail believes a “considerable opportunity” exists in the US for its version of the drug, noting that the branded drug generated annual sales of some $19.9 million dollars in the twelve months to the end of March 2005. The firm expects to enter into an agreement with a strategic partner for the marketing and distribution of the product in the US.