NEW DELHI: Sun Pharma has settled a patent litigation with US-based Acorda Therapeutics Inc over Ampyra extended-release tablets, which is used in the treatment of multiple sclerosis patients.
As per the settlement the Indian drug major can launch its generic version of the medicine in the US by 2027.
“The company, along with its subsidiary has entered into a settlement agreement with Acorda Therapeutics Inc to resolve the pending patent litigation involving Ampyra extended release tablets in the US,” Sun Pharmaceutical Industries said in a regulatory filing.
Ampyra is used to improve walking in patients with multiple sclerosis (MS).
The litigation was filed by Acorda Therapeutics in the US District Court of Delaware in response to Sun Pharma’s submission of an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration, 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 US at a specified date in 2027, or potentially earlier under certain circumstances,” the company said.
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, it added.
As per IMS MAT July 2015 sales data, Ampyra recorded annual sales of around $325 million in the US.