AndroGel Maker Colluded To Keep Generics Off Market, FTC Lawsuit Claims

Published on September 15, 2014 by Sandy Liebhard

The Federal Trade Commission (FTC) is taking the manufacturer of AndroGel to court, claiming it colluded with another pharmaceutical company to keep a cheaper, generic version of the testosterone treatment off the market. In a lawsuit filed last week, the FTC said the companies’ actions caused users of the brand-name drug to spend hundreds of millions of dollars more than what was necessary for their medication.

AbbVie, Inc., the manufacturer of AndroGel, is named as a defendant in the FTC’s lawsuit, as is Teva Pharmaceuticals. The complaint, which was filed in federal court in Philadelphia, Pennsylvania, accuses AbbVie of filing “baseless” patent infringement lawsuits against Teva and another company to stop them from bringing generic versions of the drug to market. Teva then agreed not launch its testosterone medication in return for permission to sell a generic version of a Teva cholesterol drug.

“This case underscores the commission’s continuing commitment on behalf of consumers to ensure that America’s healthcare markets remain competitive, resulting in lower drug prices and greater innovation for consumers,” the chairwoman of the FTC said during a conference call with the media last week.

According to a report from Bloomberg News, the new testosterone treatment lawsuit is the latest case filed by the FTC that targets so-called “pay-for-delay agreements,” in which the makers of brand name drugs compensate generics producers for delaying sales of lucrative medications. AndroGel is AbbVie’s second best-selling medication, and racked up $427 million in sales during the first half of 2014.

AndroGel Involved in Product Liability Litigation

The FTC’s lawsuit comes as AbbVie is facing dozens of product liability claims filed on behalf of AndroGel users who allegedly suffered serious cardiovascular side effects because of the medication. The majority of these lawsuits are pending in a multidistrict litigation underway in federal court in Chicago, where cases involving AndroGel and other testosterone replacement therapies have been consolidated for pretrial proceedings.

The testosterone litigation has been mounting since the U.S. Food & Drug Administration (FDA) announced in January that it was investigating the heart risks associated with the drugs. The agency has since released a report that questioned the benefits of testosterone replacement for the majority of men. Later this week, the FDA will convene an advisory panel meeting to take a closer look at the risks and benefits associated with the medications.