ALLEGAN — Perrigo Co. has acquired the exclusive U.S. rights to sell and distribute Levocetirizine tablets, the generic version of UCB’s Xyzal(R) tablets, from Synthon Pharmaceuticals, Inc.
Synthon believes it has a first-to-file abbreviated new drug application for the generic version of Xyzal and is in litigation with UCB over the ANDA filing. If Synthon successfully proves the existing patent is invalid, it will be entitled to six months of generic exclusivity before other generic firms can compete. Xyzal is used for the treatment of indoor and outdoor allergies. The drug generates an estimated $200 million in annual sales, and sales are growing at 15 percent per year.
“This is a prime example of Perrigo’s strategic focus on introducing new products which will make quality health care more affordable to American consumers,” stated Perrigo Chairman and CEO Joseph C. Papa. “Given Perrigo’s unique model of leadership in both the over-the-counter and generic prescription businesses, we can leverage this first-to-file
opportunity whether the brand product stays behind the pharmacy counter or if it switches to an over-the-counter status, a likely scenario.”