➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Boehringer Ingelheim
Merck
Mallinckrodt
Medtronic

Last Updated: February 28, 2021

DrugPatentWatch Database Preview

Sodium phenylbutyrate - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

Sodium phenylbutyrate is the generic ingredient in two branded drugs marketed by Horizon Therap, Par Pharm, Sigmapharm Labs Llc, and Alvogen, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are one thousand four hundred and seventy-two drug master file entries for sodium phenylbutyrate. Two suppliers are listed for this compound.

Recent Clinical Trials for sodium phenylbutyrate

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

SponsorPhase
Fondazione TelethonPhase 1/Phase 2
Alzheimer's AssociationPhase 2
Alzheimer’s Drug Discovery FoundationPhase 2

See all sodium phenylbutyrate clinical trials

Pharmacology for sodium phenylbutyrate

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
Par Pharm SODIUM PHENYLBUTYRATE sodium phenylbutyrate TABLET;ORAL 204395-001 Apr 15, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm SODIUM PHENYLBUTYRATE sodium phenylbutyrate POWDER;ORAL 203918-001 Jun 15, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Alvogen SODIUM PHENYLBUTYRATE sodium phenylbutyrate TABLET;ORAL 090910-001 Nov 18, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Horizon Therap BUPHENYL sodium phenylbutyrate TABLET;ORAL 020572-001 May 13, 1996 AB 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 sodium phenylbutyrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Horizon Therap BUPHENYL sodium phenylbutyrate POWDER;ORAL 020573-001 Apr 30, 1996   Start Trial   Start Trial
Horizon Therap BUPHENYL sodium phenylbutyrate TABLET;ORAL 020572-001 May 13, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
McKinsey
Harvard Business School
Express Scripts
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.