The pending patent litigation was filed by Acorda Therapeutics in the U.S. District Court for the District of Delaware in response to Sun Pharma's submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA), seeking marketing approval for a generic version of Ampyra.
As a result of the settlement agreement, Sun Pharma will be permitted to market a generic version of Ampyra in the United States at a specified date in 2027, or potentially earlier under certain circumstances. Details of the settlement are confidential, and the parties will submit the agreement to the Federal Trade Commission and the Department of Justice, as required by federal law. As per IMS MAT July 2015, Ampyra recorded annual sales of approximately US$ 325 million in the US.
Powered by Capital Market - Live News