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Litigation over Alleged Astellas Prograf Monopoly Growing

May 17, 2011 | Parker Waichman LLP

Antitrust litigation against Astellas Pharma Inc. over its handling of  the drug Prograf is growing.  So far, at least three Astellas Prograf antitrust lawsuits have been filed in federal courts in Massachusetts  and  Delaware, and  it seems more are expected.  The Judicial Panel on Multidistrict litigation is considering a motion requesting that all Astellas Prograf antitrust lawsuits be consolidated in a multidistrict litigation.

Prograf, which costs patients around $1,500 per month, is the brand name for tacrolimus.  It was approved in 1997, and is used to prevent organ rejection in transplant victims.

Antitrust lawsuits claim Astellas tried to hold on to its Prograf monopoly even after its exclusive patent expired by filing a “sham” petition with the U.S. Food and Drug Administration (FDA) in 2007.   The petition asked the FDA to establish more stringent standards for companies seeking approval of generic versions of tacrolimus.  When that didn't work, Astellas went to court to stop the FDA from approving a generic form of tacrolimus.  As a result, a cheaper generic version of the drug was not made available until 2009.

Astellas claimed its petition was filed in the interest of patient safety,  but plaintiffs in the Prograf antitrust lawsuits don't see it that way. Astellas was “keenly aware that it would lose a substantial amount of its sales of Prograf very quickly once AB-rated generics came to market," one complaint alleges.

Such  lawsuits further allege Astellas violated the Sherman Act by illegally maintaining a monopoly in the market for Prograf and charging supracompetitive prices for the drug. Because of this, the complaints claim Astellas was able  to overcharge purchasers of Prograf by millions of dollars.

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