Drugmakers Unlikely to Pursue Generic Xifaxan Anytime Soon

The FDA’s rigorous new bioequivalence roadmap for Salix Pharmaceuticals’ diarrhea drug Xifaxan and the antibiotic’s long-term patents likely mean scant drugmaker interest in pursuing a generic anytime soon, according to a Wall Street analyst. New draft FDA guidance on proving bioequivalence to Xifaxan (rifaximin) requires an extensive study and only covers one of the drug’s two U.S.-approved indications — traveler’s diarrhea — at a soon-to-be-obsolete dose of 200 mg. That makes it unlikely any generic-drug maker will conduct the study, Jefferies analyst Corey Davis said in a Nov. 30 note.
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