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GLYCEROL PHENYLBUTYRATE

ANDA

GLYCEROL PHENYLBUTYRATE | A205742 | PH HEALTH LTD

1 strength0 unique patents1 unique exclusivity

Reference Listed Drug: RAVICTI(TE code: AA)

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

Today

Apr. 15, 2026

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Horizon Therapeutics, LLC v. Par Pharmaceuticals, Inc. et al 1:2018cv01224 1 patentANDA 205742glycerol phenylbutyrate	D. Del.	2018-08-10	Terminated 2018-10-02	—
HORIZON THERAPEUTICS, LLC v. PAR PHARMACEUTICAL, INC. 1:2016cv03910 3 patentsANDA 205742glycerol phenylbutyrate	D.N.J.	2016-06-30	Terminated 2018-10-03	—
Horizon Therapeutics Inc v. Par Pharmaceutical Inc 2:2014cv00384 3 patentsANDA 205742glycerol phenylbutyrate	E.D. Tex.	2014-04-23	Terminated 2018-08-09	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain7 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

NURAY CHEMICALS PRIVATE LTDGLYCEROL PHENYLBUTYRATE

DMF 271252013

LUPIN MANUFACTURING SOLUTIONS LTDGLYCEROL PHENYLBUTYRATE

DMF 282982014

HETERO DRUGS LTDGLYCEROL PHENYLBUTYRATE

DMF 344682020

MSN LABORATORIES PRIVATE LTDGLYCEROL PHENYLBUTYRATE

DMF 346182020

TAPI NL BVGLYCEROL PHENYLBUTYRATE

DMF 370422022

APITORIA PHARMA PRIVATE LTDGLYCEROL PHENYLBUTYRATE

DMF 403882024

NAVINTA LLCGLYCEROL PHENYLBUTYRATE

DMF 409662025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 12, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.1GM/ML

0 patents1 exclusivity▴

LIQUID;ORAL | Approved: Dec 2, 2021

Code	Date	Status
PC	Apr 15, 2026	Expired