Perrigo’s partner Synthon has filed an ANDA for Levocetirizine solution 2.5mg/5ml, a generic version of Xyzal solution 2.5mg/5ml. Xyzal solution 2.5mg/5ml is meant for the treatment of allergies and hives.
Under the terms of the agreement, Perrigo has sales and marketing rights in Synthon’s Levocetirizine products. The company believes that Synthon is the first to file ANDA with a Paragraph IV certification against Xyzal solution, that can entitle it to 180 days of generic exclusivity upon approval.
Synthon filed ANDA for Levocetirizine solution 2.5mg/5ml containing a Paragraph IV Certification with FDA and notified UCB, the New Drug Application holder for Xyzal solution and Sepracor of its filing. On June 17, 2009, Sepracor and UCB filed suit alleging patent infringement in the US District Court for the Eastern District of North Carolina, against Synthon.