Mesalamine – USA

Mesalamine – USA

On May 09, 2017, Federal appeals court affirmed district court’s decision of non-infringement of US6773720 (expiring on Jun 8, 2020) and thus cleared the way for generic-drug maker Zydusto bring its version of Shire PLC’s gastrointestinal drug Lialda to market. Zydus was the first to file (FTF) an abbreviated new drug application (ANDA) for a generic version of Lialda. Shire has reported annual sales of $714 million for this product in 2016 in the United States.

In a separate case involving Watson, the Court of Appeals for the Federal Circuit on Feb 10, 2017 reversed district court’s decision & sent case back to the Florida Southern District Court. In this decision, the Court of Appeals noted that the first claim had “Markush” limitations. When analyzing the Watson ANDA, it concluded that its use of magnesium stearate in its formulation matrix was not part of the Markush group. As such, the Court of Appeals concluded that the Watson ANDA does not infringe.
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