A lawsuits against Astellas Pharma Inc.Our antitrust lawyers are investigating lawsuits against Astellas Pharma Inc. for illegally working to delay generic versions of the immune- suppressant medication Prograf (tacrolimus). Prograf is a drug used to prevent rejection in organ transplant patients. Astellas has been accused of filing a “sham” petition with the U.S. Food and Drug Administration (FDA) in order to keep cheaper, generic versions of Prograf off the market.
If you sustained economic damages because of Astellas’ maneuvering to stop generic competition for Prograf, our antitrust lawyers want to hear from you. We are offering free legal consultations to anyone wishing to file an Astellas Prograf antitrust lawsuit. To find out how we can help you, please contact our antitrust lawyers today.
Astellas Prograf Monopoly
Prograf (tacrolimus capsules and injection) is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, or heart transplants. The drug was first approved in 1997. Prograf is a pricey medication, and can cost as much as $1,500 per month.
Astellas filed a citizen petition in September 2007 asking the FDA to establish more stringent standards for companies seeking approval of generic versions of Prograf, including additional bioequivalence studies. The FDA rejected the petition, and Astellas sought a temporary restraining order and preliminary injunction in court to prevent the agency from approving a generic version of Prograf. In 2009, the U.S. District Court for the District of Columbia rejected Astellas’ request.
Astellas Prograf antitrust lawsuits allege that the company’s 2007 FDA petition was a “sham” that allowed it to maintain a monopoly on the market for tacrolimus for two years. Such lawsuits maintain that the only difference between generic versions of tacrolimus and Prograf is price. They further allege that Astellas was “keenly aware that it would lose a substantial amount of its sales of Prograf very quickly” once generic tacrolimus came to market. The delay in bringing generics to market allowed Astellas to overcharge purchasers of Prograf by millions of dollars, plaintiffs allege.