Forest/Merz settle with Mylan and others of generic Namenda; Impax' generic Opana cleared in USA

US generic drugmaker Mylan says that it has entered into settlement and license agreements with Forest Laboratories and Merz Pharmaceuticals related to its copy version of their Alzheimer's disease drug Namenda (memantine) tablets, 5mg and 10mg.

As a result of the so-called 'pay-to-delay' deal, Mylan will have the right to market memantine in the USA on January 11, 2015, or earlier, under certain circumstances. Namenda had US sales of $1.2 billion for the 12 months ending March 31, 2010, according to IMS Health. Additional details of the agreement remain confidential and remain subject to review by the US Department of Justice and the Federal Trade Commission, said Mylan.

Separately, Forest and Merz announced that, also subject to FTC review, they will provide licenses to each of Amneal, Watson, Dr Reddy's, Lupin, Mylan, Orchid, Sun, Teva, Upsher-Smith and Wockhardt that will permit these companies to launch their generic versions of Namenda as of the date that is the later of (a) three calendar months prior to the expiration of US Patent No 5,061,703, including any extensions and/or pediatric exclusivities or (b) the date each company receives final Food and Drug Administration approval of its Abbreviated New Drug Application, or earlier in certain circumstances.