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Azur sues Barr over clozapine ODT

This article was originally published in Scrip

Executive Summary

Azur Pharma and Cima Labs have filed suit in the US District Court for the District of Delaware againstBarr Laboratories, alleging patent infringement related to Barr's generic version of the schizophrenia product FazaClo (clozapine) orally disintegrating tablets, thus triggering the 30-month stay of approval. Azur had received notice that Barr filed an ANDA with a paragraph IV challenge to two of four Orange Book-listed patents – the '981 and the '392, expiring in April 2018, and licensed from Cima. An ex parte re-examination of the '981 patent was requested in 2005, and after filing a reply brief Cima recently requested oral argument before the Board of Patent Appeals and Interferences for the patent; an inter partes re-examination of the '392 patent was filed by KV Pharmaceutical in 2006 and is moving through the examiner's office. Barr believes it is the first to file an ANDA for the product, which generated about $34 million in US sales in the 12 months to end-June for the 25mg and 100mg doses.

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