Metformin & Pioglitazone - USA

Decision on IPR: Dec 28, 2018

AIA Review	Filing Date	Institution Date	Petitioner	US Patent	Respondent	FINAL WRITTEN DECISION
IPR2017-01648	06/22/2017	12/29/2017	Aurobindo Pharma USA Inc.	6,866,866	Andrx Labs, LLC	Claims 1–25 are patentable

US 6,866,866 (Andrx Labs, LLC; Exp: 03/17/2021) – listed in OB

1. A controlled release oral dosage form for the reduction of serum glucose levels in human patients with NIDDM, comprising an effective dose of metformin or a pharmaceutically acceptable salt thereof and a controlled-release carrier to control the release of said metformin or pharmaceutically acceptable salt thereof from said dosage form, said dosage form being suitable for providing once-a-day oral administration of the metformin or pharmaceutically acceptable salt thereof, wherein following oral administration of a single dose, the dosage form provides a mean time to maximum plasma concentration (Tmax) of the metformin from 5.5 to 7.5 hours after administration following dinner.