Monday, January 23, 2017 2:35:01 PM
Exactly right.
Epic's Generic OxyIR ANDA is already approved and shipping, and this is the ANDA that Elite gets 15% for life. Epic's generic oxy ER (OxyContin) has not yet been approved, but based on their litigation success against Purdue, it could be approved any day. Only companies who beat Purdue in court will be eligible to bypass the current OxyContin marketing exclusivity, which will be imposed by FDA until August 2018.
So Epic filed both an generic IR Oxy as well as a generic ER for OxyContin then, correct? And the IR generic has been approved and selling while Epic/PuraCap waits for the other to finally be approved now that the litigation has been settled in their favor.. Right?
Epic's Generic OxyIR ANDA is already approved and shipping, and this is the ANDA that Elite gets 15% for life. Epic's generic oxy ER (OxyContin) has not yet been approved, but based on their litigation success against Purdue, it could be approved any day. Only companies who beat Purdue in court will be eligible to bypass the current OxyContin marketing exclusivity, which will be imposed by FDA until August 2018.
Historic note: Until his life's destiny was further clarified, Robin Hood spent several years robbing from the rich and giving to the porcupines. (G. Larson 7/26/82)
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