Prasugrel – USA

Prasugrel – USA

On Sep 12, 2016, PTAB issued final written decisions finding all claims of US Patent Nos. 8,404,703 and 8,569,325 unpatentable under section 103.

Several ANDA filers filed IPR petition in Mar 2015 and asked patent office to review ‘703 & ‘325 patents which are expiring on Jul 02, 2023.The patents involved in this IPR were the subject of litigation in the Southern District of Indiana. That litigation was stayed pending resolution of the IPR.

Now the patents are invalid, ANDA filers may launch generic product after compound patent US5288726 expiry on Oct 14, 2017 unless the decision is appealed further.
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