Generic manufacturer Perrigo has acquired the exclusive U.S. rights to sell and distribute Levocetirizine tablets, the generic version of innovator UCB’s Xyzal tablets (5mg), from Synthon Pharma. Synthon was first to file ANDA application with Para IV certification against only orange book listed patent US5698558 (Expiry: September 24, 2012, which covers method of use of levocetrizine), and can get 180 days of exclusivity upon approval and successful litigation. Synthon and innovator UCB are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Synthon ANDA filing.
Earlier, innovator has filed lawsuit against Synthon, Sun Pharmaceuticals, Sandoz and Barr
Earlier news of IPPharmadoc on Xyzal litigation Here
Earlier, innovator has filed lawsuit against Synthon, Sun Pharmaceuticals, Sandoz and Barr
Earlier news of IPPharmadoc on Xyzal litigation Here
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