FDA Rejects Generic Premarin Challenge

After considering the question for more than two years, the US Food andDrug Administration has said it will not allow generic versions of American Home Products' hormone replacement product Premarin (conjugated estrogens), saying that they fail to replicate exactly the branded product. Premarin's US patent expired in 1971.

Premarin is the most widely-prescribed drug in the USA and, with eight million women taking it, had sales of $860 million last year. Furthermore, increasing attention on post-menopausal diseases such as osteoporosis have led some analysts to predict that the market for the drug could skyrocket over the next five years to $3 billion.