Glycerol phenylbutyrate - Generic Drug Details

What are the generic drug sources for glycerol phenylbutyrate and what is the scope of patent protection?

Glycerol phenylbutyrate is the generic ingredient in two branded drugs marketed by Par Pharm Inc and Horizon Therap, and is included in two NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Glycerol phenylbutyrate has one hundred and fourteen patent family members in twenty-nine countries.

There are two drug master file entries for glycerol phenylbutyrate. There is one tentative approval for this compound.

Summary for glycerol phenylbutyrate

International Patents:	114
US Patents:	16
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	10
Patent Applications:	271
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for glycerol phenylbutyrate
What excipients (inactive ingredients) are in glycerol phenylbutyrate?	glycerol phenylbutyrate excipients list
DailyMed Link:	glycerol phenylbutyrate at DailyMed

Recent Clinical Trials for glycerol phenylbutyrate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Columbia University	Early Phase 1
Weizmann Institute of Science	Phase 2/Phase 3
Kaplan Medical Center	Phase 2/Phase 3

See all glycerol phenylbutyrate clinical trials

Generic filers with tentative approvals for GLYCEROL PHENYLBUTYRATE

Applicant	Application No.	Strength	Dosage Form
		1.1G/ML	LIQUID;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for glycerol phenylbutyrate

Cryoprotective Agents

Solvents

Paragraph IV (Patent) Challenges for GLYCEROL PHENYLBUTYRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RAVICTI	Oral Liquid	glycerol phenylbutyrate	1.1 g/mL	203284	1	2013-11-19

US Patents and Regulatory Information for glycerol phenylbutyrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Horizon Therap	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013		RX	Yes	Yes
Horizon Therap	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013		RX	Yes	Yes
Horizon Therap	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013		RX	Yes	Yes

Expired US Patents for glycerol phenylbutyrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon Therap	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013

EU/EMA Drug Approvals for glycerol phenylbutyrate

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Immedica Pharma AB	Ravicti	glycerol phenylbutyrate	EMEA/H/C/003822 Ravicti is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate-synthase-I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.Ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).	Authorised	no	no	yes	2015-11-26

International Patents for glycerol phenylbutyrate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3263102	PROCÉDÉS DE SURVEILLANCE THÉRAPEUTIQUE DE MÉDICAMENTS À RÉCUPÉRATION D'AZOTE (METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS)
European Patent Office	2846791	HPN-100 DESTINÉE AU TRAITEMENT DES MALADIES DE LA RÉTENTION AZOTÉE (HPN-100 FOR USE IN THE TREATMENT OF NITROGEN RETENTION DISORDERS)
South Korea	20140094517	METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS

Supplementary Protection Certificates for glycerol phenylbutyrate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2330892	132016000126572	Italy		PRODUCT NAME: GLICEROLO FENILBUTIRRATO(RAVICTI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1062, 20151201
2330892	359 5034-2016	Slovakia		PRODUCT NAME: GLYCEROLFENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151201
2330892	CR 2016 00062	Denmark		PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201