Takeda says it has completed settlements with six out of eight defendants in patent infringement litigation concerning possible generic versions of the Japanese drugmaker’s diabetes blockbuster Actos and Actoplus Met.
The Osaka-headquartered group did not disclose any other details about the settlements or the firms who have filed Abbreviated New Drug Applications for Actos (pioglitazone ) and ActoPlus Met (pioglitazone and metformin). However Takeda did note that it is operating on the assumption that the entry of generic versions of the two drugs in the USA will be August 17, 2012 and December 14, 2012, respectively.
Takeda still has lawsuits pending against two companies – Teva Pharmaceutical Industries and Aurobindo Pharma – who hope to market their copycat versions of the drugs before the expiration of several Takeda patents in mid-2016. Until these are resolved, the company says that the dates of entry of generic Actos and Actoplus Met “are uncertain” and it is aware two other companies that have already filed ANDAs. The firm concluded by saying it is “confident in and intends to continue to enforce its patents”.
Meantime, Takeda has submitted a New Drug Application to the US Food and Drug Administration for azilsartan medoxomil, also known as TAK-491, for hypertension.
Azilsartan is an angiotensin II receptor blocker and the submission was supported by seven Phase III trials involving more than 5,900 patients. It has been studied as a once-daily oral monotherapy or in combination with other antihypertensives, and also in comparison to Daiichi Sankyo's Benicar/Olmetec (olmesartan).
Takeda will be hoping that TAK-491 will become a successor to another of its blood pressure drugs, the blockbuster Blopress (candesartan cilexetil), which will lose patent protection in the USA in 2012.