Astellas Settles Lawsuits Alleging Prograf Generics Delay

Astellas Pharma Inc. agreed to settle lawsuits over an alleged scheme to delay generic versions of its immune-suppressant drug Prograf, avoiding a trial set to start today.

Drug wholesaler plaintiffs and the Tokyo-based company announced the agreement in principle today during a telephone conference, according to a filing in Boston federal court. Terms of the accord weren't disclosed in the filing.

The Louisiana Wholesale Drug Co. and other distributors filed at least five lawsuits in 2011 against Astellas, accusing it of illegally maintaining a monopoly on the market for tacrolimus, which is marketed as Prograf.

Astellas sought to delay competition for two years by filing a “sham” petition with the U.S. Food and Drug Administration in 2007 to require safety and efficacy tests for the generics, according to the lawsuits.

Prograf, given to transplant patients to avoid organ rejection, has faced generic competition in the U.S. since August 2009, when Novartis AG’s Sandoz unit began selling the first copy of the drug. The FDA rejected Astellas’s petition that month.

Jenny Kite, a spokeswoman for Astellas in the U.S., didn’t immediately respond to phone and e-mail messages seeking comment on the settlement announcement.

Thomas Sobol and David Nalven, attorneys for the plaintiffs, also didn’t immediately respond to phone and e-mail messages seeking comment.

The case is In Re Prograf Antitrust Litigation, 11-md-2242, U.S. District Court, District of Massachusetts (Boston)

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