Impax Laboratories, Inc. today announced that it has settled all pending litigation with Shire LLC and Shire Laboratories, Inc. (collectively Shire) relating to supply of its authorized generic Adderall XR® under the parties’ License and Distribution Agreement that was signed in January 2006. As part of the settlement, the parties will submit a stipulation of dismissal for entry by the Court. Shire has agreed to make a one-time cash payment to Impax of $48 million upon the court’s order of dismissal.
Impax commenced sales of authorized generic Adderall XR in October 2009. On November 1, 2010, Impax filed suit against Shire for breach of contract and other related claims alleging that Shire failed to fill Impax’s orders for the authorized generic Adderall XR. Shire filed a counterclaim against Impax relating to its ordering practices under the agreement. Under the terms of the settlement, Impax’s claims and Shire’s counterclaims will be dismissed.
The parties have entered into an amended License and Distribution Agreement which will govern the future supply of authorized generic Adderall XR from Shire to Impax. Following the end of the supply term on September 30, 2014, Impax will continue to have the right to sell its products on hand or owed to it under the agreement until depleted and will continue to pay a profit share to Shire on sales of such products.
Impax will continue to pursue approval of its pending Abbreviated New Drug Application for generic Adderall XR which was filed with the U.S. Food and Drug Administration in September 2003.