Lupin settles litigation with Forest Labs for Alzheimer's drug

Lupin has settled all its ongoing patent litigation with US-based Forest Laboratories on the Alzheimer’s disease treatment drug, Namenda (memantine tablets). By the settlement, Lupin 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.

Sources said Lupin is believed to be the first to challenge the patent of this drug, which had sales of $949 million in the US for the financial year 2009 and accounted for 26 percent of Forest’s net revenue last year.

Such out-of-court settlements are part of the generic drug business in the US. By US rules for launching a generic drug, the generic company has to file a marketing application named Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA). If the ANDA challenges the patent of the innovator, that has to be notified to the company. Then, the innovator company has to sue the patent challenger within 45 days of receipt of notice, to prevent the FDA from approving the generic.