Glycerol Phenylbutyrate - USA

Decision on IPR: Oct 24, 2018

AIA Review	Filing Date	Institution Date	Petitioner	US Patent	Respondent	Status
IPR2018-01550	08/21/2018	--	Par Pharmaceutical, Inc.	9,561,197	Horizon Therapeutics	Terminated-Settled

On’197 patent, Lupin field IPR (IPR2018-00459) on 01/12/2018 which was terminated due to settlement on July 25, 2018.

US 9,561,197 (Horizon Therapeutics, LLC; Exp: 09/22/2030) – OB listed

1. A method of treating a urea cycle disorder in a subject comprising administering to a subject having a plasma PAA to PAGN ratio outside the target range of 1 to 2, a dosage of glyceryl tri-[4-phenylbutyrate] (HPN-100) effective to achieve a plasma PAA to PAGN ratio within the target range of 1 to 2.

2. A method of treating a urea cycle disorder in a subject comprising administering to a subject having a plasma PAA to PAGN ratio outside the target range of 1 to 2.5, a dosage of glyceryl tri-[4-phenylbutyrate] (HPN-100) effective to achieve a plasma PAA to PAGN ratio within the target range of 1 to 2.5.