Glenmark Pharmaceuticals has moved a step forward to launch another generic drug in the US. The company, which had revenue of R1,022 crore in 2009-10, on Monday said it has entered into a settlement agreement with Sepracor of US, which could pave way for the Indian firm to launch generic eszopiclone tablets, in the US market.
The settlement has also given two and a half months exclusivity for the sale of generic version of eszopiclone tablets, which is used in treating insomnia. Eszopiclone tablets, which Sepracor sells under the brand name Lunesta, had sales of $741 million (R3,500 crore) for 2009-10, according to IMS health data.
"Sepracor Inc has entered into a settlement and licence agreement with Glenmark to resolve a patent infringement suit related to its filing of an abbreviated new drug application (ANDA) with the United States Food and Drug Administration to market generic Eszopiclone tablets," said the company The tablets are the second highest selling branded prescription medication in its class in the US market.
Under the settlement, Glenmark would be permitted to launch its generic version of eszopiclone on November 30, 2013, which is two and half months prior to the expiry of Sepracor’s US patent or May 30, 2014 if Sepracor obtains pediatric exclusivity for Lunesta. Pediatric exclusivity is an add-on to an existing marketing exclusivity or patent protection.