Synthon believes that it has a first to file abbreviated new drug application (ANDA) application for the generic that can entitle it to 180 days of generic exclusivity upon approval.
Synthon and UCB are currently engaged in paragraph IV/Hatch-Waxman litigation over the Synthon ANDA filing. Xyzal is indicated for the treatment of indoor and outdoor allergies.
Joseph Papa, chairman and CEO of Perrigo, said: “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.”