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Famotidine

This article was originally published in The Tan Sheet

Executive Summary

Teva's generic equivalent to J&J/Merck's Pepcid AC was approved to carry both heartburn prevention and treatment claims, while Ivax' famotidine 10 mg may only carry prevention claim. A brief in "The Tan Sheet" July 30 incorrectly reported Ivax was the first private labeler approved to carry a prevention claim. According to FDA's Office of Generic Drugs, Teva (which licenses its product to Perrigo) challenged both indications covered by a specific patent, while Ivax challenged a separate prevention indication that was not patent-protected. As a result, Teva's famotidine carries six months of generic exclusivity while Ivax' product does not
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