Study: Small Policy Changes Could Prevent Branded ‘Evergreening’

The FDA could require drugmakers seeking NDA approval on new formulations or doses on previously approved molecules to resolve outstanding patent litigation before a new approval is granted to prevent “evergreening,” or delaying of generic competition. That’s one suggestion offered by Yale University School of Medicine professor Harlan Krumholz in an Achieves of Internal Medicine article that studied Abbott Laboratories’ tactics with its TriCor (fenofibrate) franchise.
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