Drug-maker Lupin has entered into a settlement with Santarus Inc and Depomed Inc to resolve a pending patent litigation involving diabetes medicine Glumetza or the extended release form of metformin tablets, in strengths of 1,000 mg and 500 mg.
The settlement agreement allows Lupin to sell a generic version of Glumetza on February 1, 2016, or earlier under certain circumstances, a note from Lupin said.
Glumetza extended release metformin tablets in the mentioned strengths had annual sales of about $71 million in the US for the twelve months ending December 2011. 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 added.
Lupin had in January this year received tentative approval to sell a generically similar version of this drug in the US from regulator the Food and Drugs Administration, the company said.
Further, the company claimed it was the first applicant to file an application to sell Glumetza in the US, giving it a 180-day marketing exclusivity.
Settlements
The company has, over the last several months, settled other ongoing litigations — with Sunovion on Lunesta (an insomania drug), with Forest on Memantine (to treat Alzheimer's disease) and Warner Chilcott on Loestrin and Femcon (oral contraceptive products).
Lupin's Group President and Executive Director, Mr Nilesh Gupta, had earlier told Business Line that the company would get into more such agreements. About a quarter of Lupin's new drug applications in the US are Para IV filings involving patent-related litigation.
Lupin shares were up over 3 per cent on the BSE, at Rs 477 on Thursday.