New Delhi: Drug maker Lupin today said it has reached a patent litigation settlement agreement with US-based firms Santarus Inc and Depomed Inc involving diabetes drug Glumetza.
The development, which could help the Indian firm launch its generic version of the drug by 2016, will, however, be subject to review by the US Department of Justice and the
Federal Trade Commission and other regulatory authorities.
The company and its subsidiary Lupin Pharmaceuticals Inc entered into a settlement agreement with Santarus Inc and Depomed Inc to resolve pending patent litigation involving Glumetza in the strengths of 1000 mg and 500 mg, Lupin said in a statement.
"The settlement agreement grants Lupin the right to begin selling a generic version of Glumetza on February 1, 2016, or earlier under certain circumstances," it added.
The Mumbai-headquartered firm said the settlement agreement is subject to review by the US Department of Justice and the Federal Trade Commission, as well as entry by the US
District Court for the Northern District of California of an order dismissing the litigation.
Lupin had received the tentative approval for generic Glumetza from the United States Food and Drugs Administration in January this year.
"Lupin believes it is the first applicant to file an abbreviated new drug application for Glumetza 1000 mg and 500 mg strengths and as such is entitled to 180 days of marketing exclusivity," the company said.
Depomed had sued Lupin in 2009 alleging that Lupin`s application to market a generic version of Depomed`s diabetes drug Glumetza infringed its patents.
According to IMS Health data, Glumetza extended release metformin tablets, 1000 mg and 500 mg had annual US sales of around USD 71 million for twelve months ending December, 2011.
Shares of Lupin were trading at Rs 471.95 on the BSE in afternoon trade, up 1.81 per cent from its previous close.