Metformin & Pioglitazone – USA

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.

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