Shire sues Amneal over proposed generic Lialda

Drug maker Shire, alongside two other companies, has sued Amneal Pharmaceuticals for allegedly infringing a patent related to Lialda, a drug for treating ulcerative colitis.

Shire filed its lawsuit on Wednesday (April 22) at the US District Court for the District of New Jersey. It came in response to Amneal’s filing of an Abbreviated New Drug Application (ANDA) at the US Food and Drug Administration that sought approval to market a generic version of the drug.

The dispute is related to Shire’s drug Lialda (mesalamine) and a patent that protects it, US number 6,773,720.

The patent protects the compound in the drug, which is used to help treat colitis, a condition that can cause inflammation in the colon.

The ’720 patent was granted to Cosmo Pharmaceuticals in 2004, which then granted drug maker Giuliani an exclusive licence. Giuliani itself then granted Shire an exclusive sub-licence, which it later extended to Nogra Pharma.

Giuliani and Nogra are the remaining plaintiffs.

According to the complaint, Amneal submitted its ANDA to seek approval to manufacture, use and sell generic mesalamine delayed-release tablets in 1.2g measurements.

Shire and the co-plaintiffs are seeking a judgment that the ’720 patent is valid and enforceable and that Amneal’s filing of an ANDA is an act of infringement.

The complainants have asked that any generic version of Lialda is not approved until after 2020, when the ‘720 patent expires, as well as for attorney’s fees and damages.