Mylan, Ranbaxy and Teva have won US marketing approval for their generic versions of Actos diabetes tablets
But, a fourth, Watson, has not be invited to the party and is suing the US Food and Drug Administration (FDA) for ‘improperly’ squashing its application. The company says that its application could now take a further six months to go through the system.
‘The FDA has refused to grant shared exclusivity, and seeks to unnecessarily delay the launch of Watson’s generic Actos product,’ said Paul Bisaro, Watson president and chief executive. ‘We believe that we have sound arguments that refute the FDA’s position and will seek the court’s intervention to enable approval.’
Actos has been a big brand for its owner, Japenese drugmaker Takeda: it generated annual sales of $2.7 billion ($1.7 billion) in the US, based on data from market research firm IMS Health as of 30 June 2012.