Lawsuits Claim Astellas Pharma Schemed to Hold on to Prograf Monopoly

Astellas Pharma Inc. could come to regret its attempts to delay generic versions of <"">Prograf, its immuno-suppressant drug, from coming to market. Several antitrust lawsuits have been filed against Astellas claiming a 2007 petition it filed with the Food & Drug Administration (FDA) was merely an attempt to hold onto its Prograf monopoly.

Prograf (tacrolimus) was brought to market in 1997 and is used to prevent rejection in heart, liver or kidney transplant patients. The brand name version of the drug runs around $1,500 per month, and it had been a big money maker for Astellas.

One Astellas Prograf antitrust lawsuit alleges that “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.” In 2007, faced with the expiration of its exclusive patent for Prograf, Astellas filed a petition with the FDA asking it to establish more stringent standards for companies seeking approval of generic versions of tacrolimus. The FDA rejected the petition, but it would be two years before a generic version of Prograf came to market because Astellas took the agency to court to stop it from approving generic tacrolimus. A federal judge finally rejected that request in 2009.

Astellas Prograf antitrust lawsuits allege this was all a ploy by the drug maker to avoid losing its Prograf monopoly. 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.

Several Astellas Prograf antitrust lawsuits have been filed in federal courts in Massachusetts and Delaware. Recently, a motion was filed to have these lawsuits consolidated in a multidistrict litigation.

This entry was posted in Astellas Prograf Antitrust. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.