Takeda settles Actos patent law suits with Mylan, Watson and Ranbaxy, as well as Teva and others
Japan’s largest drugmaker, Takeda Pharmaceutical (TYO: 4502), and its US subsidiary have completed settlements with all defendants in patent litigation brought against the companies in response to their Abbreviated New Drug Applications for generic Actos (pioglitazone HCl), ACTOplus met (pioglitazone HCl and metformin HCl) and duetact (pioglitazone HCl and glimepiride). Takeda filed the law suits to enforce several patents that expire in 2016 relating to these antidiabetic drugs.
Takeda has granted Mylan, Watson, and Ranbaxy licenses to enter the US market with generic copies of Actos on August 17, 2012, subject to regulatory approval, or earlier under certain circumstances.
Mylan, Watson, and Ranbaxy are first-filers of ANDAs with Paragraph IV certifications for Actos and it is anticipated that the US Food and Drug Administration will grant these companies 180-day marketing exclusivity.
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