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Generically available drug is also the subject of FDA hearings over safety and efficacy
A not-pretty scene concerning branded versions of testosterone just got worse as the Federal Trade Commission filed suit against Abbvie, makers of the AndroGel brand of testosterone, and Teva Pharma, which had tussled with Abbott Laboratories (which, at the time, owned what became AbbVie) in a fairly typical branded-vs-generic patient infringement battle. (Bevins Pharma, a partner of Abbott at the time, and Perrigo Pharma, which had another generic testosterone product trying to get on the market, were also involved; Bevins is named in the FTC action, but not Perrigo.)
According to the FTC, AbbVie and Bevins filed “baseless” infringement claims against Teva and Perrigo; filing the claims automatically creates a delay in a generic approval, which FTC claims is an anticompetitive action. Teva countersued, but in 2009 settled out of court with AbbVie, in return for AbbVie paying for an authorized generic version of another product, the cholesterol drug Tricor, which FTC alleges “made no independent business sense for AbbVie.” Both AngroGel and Tricor are billion-dollar blockbuster products.
The FTC action takes place while controversy over the testosterone products themselves are being questioned. FDA is holding panels this month on the possible safety effects of the drugs, and numerous civil lawsuits have been filed over what trial lawyers are calling “testosterone strokes,” heart attacks and deaths. As a controlled substance, it also shows up when improperly dispensed or distributed. Back in February, AbbVie issued a response to earlier FDA actions, stating that its formualtions “have more than 10 years of clinical, safety, published and post­‐marketing data, with known therapeutic risks well documented in their prescribing labels."