Glycerol phenylbutyrate - Generic Drug Details

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What are the generic drug sources for glycerol phenylbutyrate and what is the scope of 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 one hundred and one patent family members in twenty-eight countries.

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

Summary for glycerol phenylbutyrate

International Patents:	101
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	51
Suppliers / Packagers:	1
Bulk Api Vendors:	9
Clinical Trials:	7
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

Recent Clinical Trials for glycerol phenylbutyrate

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

Sponsor	Phase
Columbia University	Early Phase 1
University of Alabama at Birmingham	Phase 1/Phase 2
Johns Hopkins University	Phase 1/Phase 2

See all glycerol phenylbutyrate clinical trials

Recent Litigation for glycerol phenylbutyrate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Horizon Therapeutics, LLC v. Par Pharmaceuticals, Inc.	2018-08-10
HORIZON THERAPEUTICS, LLC v. PAR PHARMACEUTICAL, INC.	2016-06-30
Horizon Therapeutics Inc v. Par Pharmaceutical Inc	2014-04-23

See all glycerol phenylbutyrate litigation

PTAB Litigation

Petitioner	Date
Par Pharmaceutical, Inc.	2018-08-21
Lupin, Ltd.	2018-01-12
Par Pharmaceutical, Inc.	2017-07-13

See all glycerol phenylbutyrate litigation

Generic filers with tentative approvals for GLYCEROL PHENYLBUTYRATE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	1.1GRAMS/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

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

Paragraph IV (Patent) Challenges for GLYCEROL PHENYLBUTYRATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
RAVICTI	LIQUID;ORAL	glycerol phenylbutyrate	203284

US Patents and Regulatory Information for glycerol phenylbutyrate

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Glossary

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

Expired US Patents for glycerol phenylbutyrate

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

International Patents for glycerol phenylbutyrate

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Country	Patent Number	Estimated Expiration
Turkey	201816616	Start Trial
Netherlands	300854	Start Trial
Lithuania	3133396	Start Trial
South Africa	201401851	Start Trial
Japan	6425746	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for glycerol phenylbutyrate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2330892	CA 2016 00062	Denmark	Start Trial	PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201
2330892	CR 2016 00062	Denmark	Start Trial	PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201
2330892	300854	Netherlands	Start Trial	PRODUCT NAME: GLYCEROLFENYLBUTYRAAT; REGISTRATION NO/DATE: EU/1/15/1062 20151201
2330892	93351	Luxembourg	Start Trial	PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1062
2330892	C20160044 00204	Estonia	Start Trial	PRODUCT NAME: GLUETSEROOLFENUEUELBUTUERAAT;REG NO/DATE: EU/1/15/1062 01.12.2015
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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