Glycerol Phenylbutyrate – USA

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.

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