Esomeprazole & Naproxen

IPR decision: Sep 06, 2019

AIA Review #	Filing Date	Institution Decision Date	Petitioner	Patent	Respondent	Status
IPR2018-00272	12/04/2017	06/14/2018	Mylan Pharmaceuticals Inc.*/ DRL	9,393,208	Horizon Pharma	Claims 1–7 unpatentable

* PTAB terminated the proceeding between Petitioner Mylan  Pharmaceuticals Inc. and Patent Owners by Order on August 12, 2019. Petitioner Dr. Reddy’s Laboratories, Inc. (“Dr. Reddy’s”) from IPR2018-1341 was joined as Petitioner to this proceeding on April 1, 2019. Dr. Reddy’s remains as a Petitioner in this case.

US 9,393,208 (Pozen Inc./ Horizon Pharma USA, Inc.; Exp: 09/03/2029) – OB listed

1. A method for delivering a pharmaceutical composition to a patient in need thereof, comprising: orally administering to the patient an AM unit dose form and, 10 hours (.+-.20%) later, a PM unit dose form, wherein: the AM and PM unit dose forms each comprises: i) naproxen, or a pharmaceutically acceptable salt thereof, in an amount to provide 500 mg of naproxen, and ii) esomeprazole, or a pharmaceutically acceptable salt thereof, in an amount to provide 20 mg of esomeprazole; said esomeprazole, or pharmaceutically acceptable salt thereof, is released from said AM and PM unit dose forms at a pH of 0 or greater, the AM and PM unit dose forms target: i) a pharmacokinetic (pk) profile for naproxen where: a) for the AM dose of naproxen, the mean C.sub.max is 86.2 .mu.g/mL (.+-.20%) and the median T.sub.max is 3.0 hours (.+-.20%); and b) for the PM dose of naproxen, the mean C.sub.max is 76.8 .mu.g/mL (.+-.20%) and the median T.sub.max is 10 hours (.+-.20%); and ii) a pharmacokinetic (pk) profile for esomeprazole where: a) for the AM dose of esomeprazole, the mean area under the plasma concentration-time curve from when the AM dose is administered to 10 hours (.+-.20%) after the AM dose is administered (AUC0-10,am) is 1216 hr*ng/mL (.+-.20%), b) for the PM dose of esomeprazole, the mean area under the plasma concentration-time curve from when the PM dose is administered to 14 hours (.+-.20%) after the PM dose is administered (AUC0-14,pm) is 919 hr*ng/mL (.+-.20%), and c) the total mean area under the plasma concentration-time curve for esomeprazole from when the AM dose is administered to 24 hours (.+-.20%) after the AM dose is administered (AUC0-24) is 2000 hr*ng/mL (.+-.20%); and the AM and PM unit dose forms further target a mean % time at which intragastric pH remains at about 4.0 or greater for about a 24 hour period after reaching steady state that is at least about 60%.