Orchid also settles Namenda patent issues with Forest Labs

29 Apr 2010

Drug firm Orchid Chemicals and Pharmaceuticals Ltd said today that it has settled a patent litigation with Forest Laboratories Inc regarding its generic drug Memantine tablets, used for the treatment of Alzheimer disease.

Memantine tablets are the generic equivalent of Forest Laboratories' Namenda tablets, on which the New York City-based Forest Labs had earlier settled similar patent issues with another Indian drug firm Lupin.

Post settlement, Orchid will be free to commercially launch this product in January 2015, or earlier in certain circumstances, said the Chennai-based drug maker.

Orchid had contested in 2007 on the grounds that the patent was invalid or had not been infringed, resulting in the subsequent litigation with Forest, which if accepted, would have given a 180-day exclusivity period to Orchid for marketing the drug in the US.

Namenda had sales of approximately $950 million in 2009 in the US, and accounted for 26 per cent of Forest Labs' net revenue last year.

Orchid said that additional terms of the settlement are confidential, and the agreement was subject to review by the Department of Justice and the Federal Trade Commission.

In December 2009, Lupin settled all litigations relating to Namenda (Memantine) tablets under the same terms arrived with Orchid. (See: Lupin settles dispute with Forest Labs over Namenda)

This month, Sun Pharmaceutical Industries Ltd, the US subsidiary of one of India's largest generic drug maker, was granted a tentative approval to market Namenda tablets by the US Food and Drug Administration. (See: Sun Pharmaceutical gets tentative US FDA approval for Alzheimer's treatment)