ALLEGAN, Mich. — Perrigo Co. and its partner Synthon Pharmaceuticals Inc. announced that Perrigo has begun shipping levocetirizine solution, 2.5 mg/5ml.
Perrigo said Monday that the product is a generic version of UCB’s Xyzal Oral Solution, indicated for the treatment of indoor and outdoor allergies.
Synthon has the first-to-file ANDA (abbreviated new drug application) for the generic that entitles it to 180 days of generic exclusivity, according to Perrigo, which manufactures the generic product. The company added that Hatch-Waxman litigation for the product was settled earlier this year.
Xyzal Oral Solution has estimated annual sales of about $12 million, according to Wolters Kluwer data cited by Perrigo.
