Glycerol phenylbutyrate - USA

IPR decision (Jul 26, 2018):

AIA Review	Filing Date	Institution Date	Petitioner	Patent No.	Final Written Decision
IPR2017-01159	03/27/2017	09/28/2017	Lupin Ltd.	9,254,278	Terminated-Settled
IPR2017-01160	03/27/2017	09/28/2017	Lupin Ltd.	9,326,966	Terminated-Settled

On US’278 patent, Par Pharma filed IPR (IPR2017-01767) on 07/13/2017, which was instituted on 01/30/2018.

On US’966 patent, Par Pharma filed IPR (IPR2017-01769) on 07/13/2017, which was instituted on 01/30/2018.

US 9,254,278 & US 9,326,966 patents owned by Horizon Therapeutics are expiring on 03/09/2032. These patents claim method of treating & method for adjusting the dosage of glyceryl tri-[4-phenylbutyrate in urea cycle disorder.

Previously, on June 27, Horizon Pharma entered into a Settlement and License Agreement with Lupin Pharmaceuticals relating to RAVICTI Oral Liquid, 1.1 gm/mL. Specifically, the Settlement Agreement pertains to on-going patent infringement litigation against Lupin in the U.S. District Court for the District of New Jersey. The Settlement Agreement also includes the pending IPRs. Under the Settlement Agreement, the License Effective Date is July 1, 2026; however, Lupin may be able to enter the market earlier in certain circumstances.