Takeda has settled patent lawsuits against a number of generic drugmakers that sought US Food and Drug Administration (FDA) approval for generic versions of the company's Actos stable of type II diabetes drugs.
The lawsuits were filed in response to abbreviated new drug applications (ANDA) submitted to the FDA by Mylan, Watson, Ranbaxy, Sandoz, Teva, Alphapharm, Torrent, Dr Reddy's Laboratories, Wockhardt, Synthon, and Aurobindo. The companies were seeking approval of generic Actos (pioglitazone HCl), ACTOplus met (pioglitazone HCl and metformin HCl), and duetact (pioglitazone HCl and glimepiride).
Takeda said it filed the lawsuits to enforce patents covering the medicines that do not expire until 2016. The company has acknowledged, however, that generic competition will likely enter the market before the patents expire, and has said its long-range plans assume that generic Actos will launch in mid-August 2012, with generic versions of ACTOplus met and duetact following in mid-December 2012.
Under the settlement agreements, Mylan, Watson, and Ranbaxy have been granted licenses to launch generic Actos in the US on August 17, 2012. The trio of companies were the first-filers of ANDAs containing "paragraph IV" patent challenges, which means that they will likely be granted 180 days of generic marketing exclusivity by the FDA.
Takeda's settlements with Alphapharm, Sandoz, Aurobindo, Dr Reddy, Wockhardt, Synthon, Teva, and Torrent grant the companies licences to enter the US market with generic Actos 180 days following the launch by the first three companies.
The settlement with Mylan includes a license to launch generic ACTOplus met in the US on December 14, 2012. Sandoz, Ranbaxy, Torrent, Watson, Aurobindo, Wockhardt, and Teva have all been granted licences to enter the US market with generic ACTOplus 180 days after Mylan, which was the first-filer of the patent challenge.
Teva has also been licensed to market an authorised generic version of Actos in the US beginning on August 17, 2012, and an authorised generic version of ACTOplus met beginning on December 14, 2012.
Sandoz has been licensed to enter the US market with generic duetact on December 14.