The Quest for a Generic Premarin – A Bitter Pill to Swallow

Tuesday's Horse

BY JANE ALLIN

The story of the quest for a generic Premarin is an interesting one – one that dates back to the mid 1980’s when the FDA announced that Premarin was effective in combating the bone loss associated with osteoporosis.

To this day an Abbreviated New Drug Application (ANDA) for a generic version has yet to be approved by the FDA – more than 20 years after two companies vying for a piece of the pie lost their bids to market a generic version of Premarin.

The history behind the failure of the FDA to approve any generic version of Premarin is intriguing yet pretentiously motivated based on a so-called “impurity” named delta 8,9-DHES.

Premarin’s patent expired in 1971 and until 1986, when the news of its efficacy in minimizing bone loss associated with osteoporosis was publicized, there was little to no interest from competing drug companies to produce…

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