Glenmark has entered into a settlement agreement with US-based Sepracor on a patent litigation suit related to the generic versions of insomnia drug eszopiclone, which Sepracor markets under the brand name, Lunesta.
Glenmark would be permitted to launch its generic product after November 30, 2013, two and a half month prior to the expiry of Sepracor’s US patent, or May 30, 2014, if Sepracor obtains pediatric exclusivity for Lunesta, according to a Glenmark statement.
Lunesta is sold in 1mg, 2mg and 3mg tablets and is indicated for the treatment of insomnia. According to IMS Health data for the year ending March 2010, Lunesta had annual sales of $741 million and was the second-highest selling branded prescription medication in its class.
The decision would be upon approval and entry of a consent Judgment and order of permanent injunction by the United States District Court for the District of New Jersey, said Glenmark.
The settlement and licence agreement would permit Glenmark to launch its generic product earlier under certain circumstances.
“The court’s approval of the proposed consent judgment and order of permanent injunction would dismiss Sepracor’s and Glenmark’s respective claims and defences without prejudice in the consolidated litigation currently pending against Glenmark and other defendants,” said Glenmark.
