Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it has initiated litigation against Shire LLC and Shire Laboratories, Inc. ("Shire") in order to resolve recent and recurring supply issues of its authorized generic version of Adderall XR®. The Company is seeking to compel Shire to deliver duly ordered amounts of product under the parties' Settlement Agreement and License and Distribution Agreements.
Larry Hsu, Ph.D., president and chief executive officer of Impax Laboratories, said: "Since launching our generic product in October of 2009, we have experienced very strong customer demand, as reflected in our strong sales of the product earlier in the year. Because of Shire's failure to continue to supply us with product in accordance with our agreement, we have been unable to continue to satisfy our customers' demands, resulting in declining sales and market share for this product. Throughout the year we have made numerous attempts to resolve the ongoing supply issues, and based on representations by Shire, we anticipated a significant increase in our fourth quarter sales over third quarter levels. According to very recent statements by Shire, however, it appears that Shire has no intention of filling our open orders, and we therefore believe we had no alternative but to bring this lawsuit in order to protect the interests of our customers and shareholders."
In January 2006, Impax Laboratories entered into a Settlement Agreement and a License and Distribution Agreement with Shire as part of a settlement of patent litigation between the parties. Under the settlement, Shire permitted the Company to enter the market as Shire's authorized generic and market generic versions of Adderall XR® Capsules in the United States. On or about October 1, 2009, Global Pharmaceuticals, Impax's generic division, commenced sales of its authorized generic version of Adderall XR® Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30mg.