Takeda completes raft of settlements in US generic Actos litigation
This article was originally published in Scrip
Takeda has now reached settlements with all of the defendants in patent infringement litigation that it had brought against filers of US ANDAs for generic versions of its big-selling oral antidiabetic, Actos (pioglitazone), and two combinations of this.
Agreements were struck with several firms earlier this year, which have now been extended to all 12 defendants: Alphapharm, Aurobindo, Breckenridge, Dr Reddy's, Mylan, Ranbaxy, Sandoz, Synthon, Teva, Torrent, Watson and Wockhardt. The legal action was originally brought with regard to several patents for the products that are due to expire in 2016.
The deals remove much of the uncertainty surrounding the timing of generic competition in the US for pioglitazone, for which Takeda reported US sales of $1.74 billion in the first half to 30 September. The Japanese firm had already assumed in its mid-term outlook that this would occur at the times now formally agreed to under the settlements, and said it would therefore not revise its current forecasts.
Under the terms of the new and already agreed settlements, Takeda has granted Mylan, Ranbaxy and Watson licences to enter the US market with generic versions of Actos on 17 August 2012, or earlier under certain circumstances. The three firms are first-filers with paragraph IV certification, and are thus expected to be granted 180-day marketing exclusivity.
Teva has also been granted a licence to market an authorised generic version of Actos from the same date, or earlier under certain circumstances. Teva, along with the remaining eight defendants, have also been granted licences to enter the market 180 days after the first-filers.
For the combination products, Mylan has been awarded a licence to market Actoplus Met (pioglitazone plus metformin) on or after 14 December 2012, or earlier under certain circumstances. As first-filer, Mylan is expected to get 180-day exclusivity, while Aurobindo, Ranbaxy, Sandoz, Teva, Torrent, Watson and Wockhardt have licences to enter the market after this period, or earlier under certain conditions.
In addition, Teva has received a licence to market an authorised generic of the product beginning the same date or earlier in certain circumstances.
Finally, a licence has been granted to Sandoz for the launch of Duetact (pioglitazone plus glimepiride) on 14 December 2012 or earlier under certain circumstances.