AbbVie, Teva Pharmaceutical Industries Limited Illegally Blocked Generic Version Of AndroGel: Federal Trade Commission

AbbVie, Teva Pharmaceutical Industries Limited Illegally Blocked Generic Version Of AndroGel: Federal Trade Commission

September 9, 2014

By Krystle Vermes, BioSpace.com Breaking News Staff

On Sept. 8, the Federal Trade Commission announced that it is suing AbbVie , a biopharmaceutical company, in addition to other businesses for delaying the release of low-cost versions of AbbVie’s drug, AndroGel.

AndroGel is a testosterone replacement drug. AbbVie and Teva Pharmaceutical Industries Limited allegedly slowed down the introduction of a generic version of AndroGel to the market.

“The FTC is acting today to stop anticompetitive conduct by AbbVie, Besins Healthcare and Teva which has forced consumers to overpay hundreds of millions for the drug AndroGel,” said FTC Chairwoman Edith Ramirez. “This action also reinforces the Commission’s longstanding commitment to protect American consumers from collusive arrangements between branded and generic pharmaceutical companies that inflate the prices of prescription drugs and harm competition.”

The FTC claims that AbbVie and its partner Besins Healthcare Inc. filed patent infringement lawsuits against generic competitors, which had no firm basis. This was designed to slow down the release of other testosterone replacement drugs, which were more affordable in comparison to AndroGel.

As the lawsuits were pending, AbbVie entered an anticompetitive pay-for-delay settlement agreement with Teva Pharmaceuticals. This was thought to be a move to further delay the release of generic drugs.

Teva allegedly realized that it would be more profitable to drop the patent challenge and eliminate competition in the testosterone gel market.

“Today’s complaint follows a long line of cases the FTC has brought to stop anticompetitive conduct in the pharmaceutical industry,” read a statement from the FTC. “The FTC is seeking a court judgment declaring that the defendants’ conduct violates the FTC Act, ordering the companies to disgorge their ill-gotten gains, and permanently barring them from engaging in similar anticompetitive behavior in the future.”

The active ingredient in AndroGel is isopropyl myristate, also known as IPM. It’s known to speed up the delivery of testosterone through the skin and into the bloodstream. The patent on AndroGel only covers a formulation that includes IPM as a penetration enhancer, according to the FTC.

AndroGel has annual sales of more than $1 billion in the U.S.

The complaint that has been filed by the FTC also names AbbVie’s predecessor, Abbott Laboratories , as well as Unimed Pharmaceuticals, Inc. , as defendants in the case.

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