FDA Rejects Generic Premarin Challenge

11 May 1997

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.

The branded product is derived from the urine of pregnant mares, and contains a variety of different estrogens, including delta 8, 9 dehydroestrone sulfate. Delta 8, 9 DHES has been at the center of AHP's defence against the generic challenge. It is present in relatively small quantities in Premarin, but is not included in any of the synthetic generics. The generic manufacturers have insisted that delta 8, 9 DHES is not required for efficacy, while AHP maintained the opposite.

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