US drugmaker Perrigo has acquired the exclusive US rights to sell and distribute levocetirizine tablets, the generic version of Belgium-based UCB's Xyzal tablets, from Synthon Pharmaceuticals. The latter firm believes it has a first-to-file Abbreviated New Drug 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. It is estimated that it has annual sales of around $200.0 million and growing at 15% per year, according to data provided by Wolters, Kluwer that was quoted by Perrigo.
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