Mumbai-based pharma major Lupin Ltd has received the final approval from US Food and Drug Administration (FDA) to manufacture and market in the US a generic version of Sanofi Aventis’ Ambien CR Extended-release tablets, used in treating sleep disorders.
The Zolpidem Tartrate Extended‐release tablets 6.25 mg and 12.5 mg is advised for the treatment of insomnia characterised by difficulties with sleep onset and sleep maintenance.
Lupin’s wholly owned US subsidiary Lupin Pharmaceuticals Inc. (LPI) will start marketing the product shortly, the company said in a release.
Sanofi’s Ambien CR Extended-release tablets had annual US sales of around $366 million in FY 2013.
“Lupin is looking for US FDA approval for 20-30 generic drugs this year. This is one of those approvals. The company has a three-pronged strategy to target the markets of Japan, the US and India. We believe that there will be good growth for all these geographies this year,” Siddhant Khandekar, chief manager – research of ICICI Securities told VCCircle.
Lupin's cumulative abbreviated new drug application (ANDA) filings with the USFDA stands at 177 with the company having received 86 approvals as of the quarter ended June 30, 2013.
Lupin's shares closed at Rs 836.80 on Wednesday.
(Edited by Joby Puthuparampil Johnson)