Mylan Pharmaceuticals, a subsidiary of Mylan, is set to launch Crohn's disease drug Budesonide Capsules, 3mg (Enteric Coated) in the US, following victory in patent litigation case against Astrazeneca.
The lawsuit was filed in connection with the abbreviated new drug application (ANDA) for Budesonide Capsules, 3mg, a generic version of AstraZeneca’s Entocort EC capsules.
The US District Court for the District of Delaware has found after trial that Mylan Pharma does not infringe the asserted claims of US patent no. 5,643,602.
At present, the company has around 164 ANDAs pending the US Food and Drug Administration approval.