Glycerol phenylbutyrate - Generic Drug Details

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What are the generic drug sources for glycerol phenylbutyrate and what is the scope of freedom to operate?

Glycerol phenylbutyrate is the generic ingredient in two branded drugs marketed by Endo Operations and Horizon Therap Us, and is included in two NDAs. 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 fourteen patent family members in twenty-nine countries.

There are two 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:	114
US Patents:	15
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	11
Patent Applications:	110
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
Technical University of Munich	Phase 2
Columbia University	Early Phase 1
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
⤷ Sign Up	⤷ Sign Up	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.

Pharmacology for glycerol phenylbutyrate

Drug Class	Nitrogen Binding Agent
Mechanism of Action	Ammonium Ion Binding Activity

Medical Subject Heading (MeSH) Categories for glycerol phenylbutyrate

Cryoprotective Agents
Solvents

Anatomical Therapeutic Chemical (ATC) Classes for glycerol phenylbutyrate

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

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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 Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for glycerol phenylbutyrate

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for glycerol phenylbutyrate

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009134460		⤷ Sign Up
Hungary	E040503		⤷ Sign Up
Lithuania	3133396		⤷ Sign Up
Israel	235127	Hpn-100 לשימוש בטיפול במחלות קשורות לעצירת חנקן (Hpn-100 for use in the treatment of nitrogen retention disorders)	⤷ Sign Up
Denmark	2760479		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for glycerol phenylbutyrate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2330892	93351	Luxembourg	⤷ Sign Up	PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1062
2330892	SPC/GB17/001	United Kingdom	⤷ Sign Up	PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REGISTERED: UK EU/1/15/1062 20151201; UK PLGB53487/0001 20151201
2330892	635	Finland	⤷ Sign Up
2330892	122016000107	Germany	⤷ Sign Up	PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892	359 5034-2016	Slovakia	⤷ Sign Up	PRODUCT NAME: GLYCEROLFENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151201
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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