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Last Updated: April 18, 2021

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SODIUM PHENYLBUTYRATE Drug Profile

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

Sodium Phenylbutyrate is a drug marketed by Par Pharm, Sigmapharm Labs Llc, and Alvogen. and is included in four NDAs.

The generic ingredient in SODIUM PHENYLBUTYRATE is sodium phenylbutyrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Two 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 SIGMAPHARM LABS LLC on March 22nd, 2013.

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Drug patent expirations by year for SODIUM PHENYLBUTYRATE
Recent Clinical Trials for SODIUM PHENYLBUTYRATE

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SponsorPhase
Fondazione TelethonPhase 1/Phase 2
Amylyx Pharmaceuticals Inc.Phase 2
Alzheimer's AssociationPhase 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 POWDER;ORAL 203918-001 Jun 15, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm SODIUM PHENYLBUTYRATE sodium phenylbutyrate TABLET;ORAL 204395-001 Apr 15, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Sigmapharm Labs Llc SODIUM PHENYLBUTYRATE sodium phenylbutyrate POWDER;ORAL 202819-001 Mar 22, 2013 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Dow
Colorcon
Medtronic
Baxter
Johnson and Johnson

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