Takeda Wins Patent Infringement Litigation on Pioglitazone hydrochloride

Takeda Pharm announced that the U.S. Supreme Court denied the Petition for a Writ of Certiorari by Alphapharm
The Supreme Court decision finally affirms the Appeals Court decision upholding the validity of Takeda’s US4687777 (Expiry: JAN 17,2011) which covers novel thiazolidinedione derivatives, a method of preparing them and antidiabetic agents containing same, which are utilized in the field of medicines including Pioglitazone hydrochloride, the active ingredient in ACTOS® as product. The decision arises from a lawsuit brought by Takeda and TPNA in March 2004 in order to oppose an Abbreviated New Drug Application (ANDA) filed by Alphapharm
Based on this final decision, the FDA will not approve and Alpharpharm Pty Ltd. may not launch a generic version of pioglitazone until the 777’ patent expires in 2011.
Takeda has other 10 patents listed in Orange book covering methods of treatment use and compositions of Pioglitazone hydrochloride.