Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Takeda and its wholly owned subsidiary Takeda Pharmaceuticals North America have announced that, on March 31, 2008, the US Supreme Court denied a petition by Alphapharm for a reconsideration of a previous appeals court decision against its plans to make a generic version of Actos.
Subscribe to our email newsletter
The decision upholds the validity of Takeda’s US patent covering pioglitazone hydrochloride, the active ingredient in Actos, which is used to control blood sugar levels in patients with type 2 diabetes. The patent does not expire until 2011, but Aphapharm had sought to manufacture and market a generic diabetes treatment containing the ingredient.
Takeda and its US subsidiary filed the original lawsuit in March 2004, when Alphapharm filed an Abbreviated New Drug Application for its pioglitazone-based drug with the FDA.
Based on this final decision, the FDA will not approve any generic version of pioglitazone until the patent expires in 2011. Takeda owns other US patents covering certain methods of treatment using pioglitazone hydrochloride, and compositions that include pioglitazone hydrochloride.
Yoichi Okumura, Takeda’s general manager of intellectual property, said: “We have profound respect for the protection of intellectual property rights because innovation is critical to us as an R&D-oriented pharmaceutical company.”