Levocetirizine Solution, 2.5 mg/5ml is the generic version of UCB’s Xyzal Oral Solution, indicated for the treatment of indoor and outdoor allergies.
Synthon and UCB are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Synthon ANDA filing.
Rudy Mareel CEO Synthon said Levocetirizine is a prime example of several ANDAs for which Synthon has obtained ‘First-Filer’-status with 180 days Hatch-Waxman marketing exclusivity.
Perrigo is a developer, manufacturer and distributer of OTC and generic prescription (Rx) pharmaceuticals.
Synthon Pharmaceuticals markets generic drugs through partnerships with other pharmaceutical companies.