![]() ![]() These discoveries in hand, the inventors came up with the scheme of giving lower dosages of oxymorphone to individuals with lower clearance rates. The inventors here used the metabolite creatine as an easier to measure proxy for measuring drug clearance (creatine clearance rate) since it comes out in the urine. In their research, they discovered that some folks clear the drug faster (and have fewer kidney problems). The inventors here were concerned about renal impairment experienced by some folks taking oxymorphone. “Administering” the drug with dosage calculated based upon the patient’s creatine clearance rate (using a particular formula).“Measuring” the patient’s creatine clearance rate and.“Providing” the drug (5 to 80 mg of oxymorphone in a controlled release matrix).2019)Įndo’s patents at issue on appeal claim a personalized method-of-treatment that has three distinct steps: The appeal here is focused on one a subset of the patents covering Opana - a fight between Endo and generic manufacturers who want to start distributing the drug once again.Įndo Pharmaceuticals Inc. In response to a new FDA request, Endo again removed the reformulated version from the market. Endo had previously pulled Opana ER from the market in 2012 and then re-launched in a “non-crushable form.” However, that form continued to be abused (including by liquefying and injecting). ![]() ![]() In 2017, the FDA requested that (reformulated) Opana ER be removed from the market in response to the high risk of its illicit use. This case focuses on patents covering the opioid drug oxymorphone that Endo sells as Opana ER. ![]()
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