SODIUM PHENYLBUTYRATE Drug Patent Profile

« Back to Dashboard

When do Sodium Phenylbutyrate patents expire, and when can generic versions of Sodium Phenylbutyrate launch?

Sodium Phenylbutyrate is a drug marketed by Ph Health, Sigmapharm Labs Llc, Alvogen, Glenmark Pharms Ltd, and Navinta Llc. and is included in six NDAs.

The generic ingredient in SODIUM PHENYLBUTYRATE is sodium phenylbutyrate. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sodium Phenylbutyrate

A generic version of SODIUM PHENYLBUTYRATE was approved as sodium phenylbutyrate by PH HEALTH on April 15^th, 2016.

Summary for SODIUM PHENYLBUTYRATE

US Patents:	0
Applicants:	5
NDAs:	6
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	43
Patent Applications:	2,467
DailyMed Link:	SODIUM PHENYLBUTYRATE at DailyMed

Recent Clinical Trials for SODIUM PHENYLBUTYRATE

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

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	EARLY_PHASE1
University of Pennsylvania	EARLY_PHASE1
Jerry Vockley, MD, PhD	PHASE1

See all SODIUM PHENYLBUTYRATE clinical trials

Pharmacology for SODIUM PHENYLBUTYRATE

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

Anatomical Therapeutic Chemical (ATC) Classes for SODIUM PHENYLBUTYRATE

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for SODIUM PHENYLBUTYRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ph Health	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	POWDER;ORAL	203918-001	Jun 15, 2016		RX	No	Yes
Glenmark Pharms Ltd	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	TABLET;ORAL	216462-001	Nov 1, 2022	AB	RX	No	No
Sigmapharm Labs Llc	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	POWDER;ORAL	202819-001	Mar 22, 2013		DISCN	No	No
Alvogen	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	TABLET;ORAL	090910-001	Nov 18, 2011		DISCN	No	No
Ph Health	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	TABLET;ORAL	204395-001	Apr 15, 2016	AB	RX	No	Yes
Navinta Llc	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	TABLET;ORAL	220418-001	Feb 17, 2026	AB	RX	No	No

EU/EMA Drug Approvals for SODIUM PHENYLBUTYRATE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eurocept International B. V.	Pheburane	sodium phenylbutyrate	EMEA/H/C/002500Treatment of chronic management of urea-cycle disorders.	Authorised	no	no	no	2013-07-30
Immedica Pharma AB	Ammonaps	sodium phenylbutyrate	EMEA/H/C/000219Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase.It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.	Authorised	no	no	no	1999-12-07