Jockeying for market exclusivity; RAC begins to resurface
WASHINGTON - Biotechnology and research-based pharmaceutical companies have reacted favorably to FDA's proposal to extend the marketing exclusivity period for newly approved products based on a single enantiomer of a previously approved racemate to five years from the current three-year period.
In comments filed with the agency, generic drug manufacturers predictably expressed opposition to the proposal, which could give manufacturers an additional two years of protection from generic competition.
Interneuron Pharmaceuticals Inc.'s Redux dexfenfluramine, which was approved in April 1996 as a treatment for obesity, was the first single enantiomer of a previously approved racemate (fenfluramine) to be approved in the U.S. FDA wants to create incentives for manufacturers to evaluate additional single enantiomer products, also known as racemic switches.
Sepracor Inc. (SEPR, Marlborough, Mass.)