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Glycerol phenylbutyrate - Generic Drug Details

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

Glycerol phenylbutyrate is the generic ingredient in one branded drug marketed by Horizon Therap and is included in one NDA. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Glycerol phenylbutyrate has ninety-three patent family members in twenty-seven countries.

There are fifty-one drug master file entries for glycerol phenylbutyrate. One supplier is listed for this compound.

Summary for glycerol phenylbutyrate

International Patents:	93
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	51
Suppliers / Packagers:	1
Bulk Api Vendors:	8
Clinical Trials:	6
Patent Applications:	10
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for glycerol phenylbutyrate
DailyMed Link:	glycerol phenylbutyrate at DailyMed

Medical Subject Heading (MeSH) Categories for glycerol phenylbutyrate

Cryoprotective Agents

Solvents

Synonyms for glycerol phenylbutyrate

611168-24-2

AKOS030238862

Benzenebutanoic acid, 1,1',1''-(1,2,3-propanetriyl) ester

CHEBI:134745

CHEMBL2105745

CS-0017499

D10127

DB08909

DTXSID40210005

Glycerol phenylbutyrate (USAN)

Glycerol phenylbutyrate [USAN:INN]

Glycerolphenylbutyrate

Glyceryl Tri-4-Phenylbutyrate

GT4P

HPN 100

HPN-100

HY-B2087

Propane-1,2,3-triyl tris(4-phenylbutanoate)

Ravicti

Ravicti (TN)

SCHEMBL10102804

Tris(4-phenylbutyryl)glycerol

UNII-ZH6F1VCV7B

ZH6F1VCV7B

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
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

International Patents for glycerol phenylbutyrate

Country	Patent Number	Estimated Expiration
United Kingdom	0915545
Poland	2330892
Slovenia	2760479
Hungary	E029912
World Intellectual Property Organization (WIPO)	2013158145

Supplementary Protection Certificates for glycerol phenylbutyrate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2330892	93351	Luxembourg		PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1062
2330892	2016023	Norway		PRODUCT NAME: GLYCEROLFENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062 20151210
2330892	CA 2016 00062	Denmark		PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201
2330892	122016000107	Germany		PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892	63/2016	Austria		PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 (MITTEILUNG) 20151201