Cinacalcet: Injunction granted against Barr/Teva


Amgen today announced that district court of delaware has granted injunction preventing launch of Teva and Barr’s generic versions of cinacalcet.

Teva and Barr has received tentative approval from FDA on early 2010. Teva has tentative approval for 90 MG only; approved on April 2010 and Barr has tentaive approval for all strengths (30, 60 & 90 MG);  approved on May 2010.

Three patents were the subject of the injunction: U.S. Patent No. 6,011,068 (“the `068 patent”) and U.S. Patent No. 6,031,003 expire Dec.14, 2016, but the `068 patent is the subject of a patent term extension which will extend the term toMarch 8, 2018.  U.S. Patent No. 6,211,244 expires Oct. 23, 2015.

Amgen press release and Note: Teva had sued Amgen for patent infringement of 7,449,603 in May 2009. The ‘603 patent is related to process of preparing cinacalcet.

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About Guna

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