MUMBAI - Pharma major, Lupin Ltd. announced today that it has settled all ongoing Hatch-Waxman litigation relating to Memantine tablets, Lupin’s generic version of Forest Laboratories Inc.’s Alzheimer disease treatment “Namenda®” Tablets.
A press release by the company stated that as per the terms of the settlement, Lupin Ltd. will be licensed under the relevant patents and would be free to commercially launch its generic product in January, 2015, or earlier in certain circumstances.
Lupin had earlier filed a Paragraph IV certification to US Patent No. 5,061,703, contesting that the patent was invalid or had not been infringed, resulting in the subsequent litigation with Forest.
Forest’s Namenda tablets had US sales of $ 949 million for the financial year 2009 and accounted for twenty-six percent of the company’s net revenue last year.
Commenting on the settlement, Nilesh Gupta, Group president and executive director to the Board, Lupin said, “The settlement with Forest is in line with us prudently managing our litigation pipeline and creating value for the company. We are committed to bringing high quality, cost effective products to the market in the earliest time frame possible”.
Headquartered in Mumbai, India, Lupin Limited is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world.