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Last Updated: November 14, 2024

SODIUM PHENYLBUTYRATE Drug Patent 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 Endo Operations, Sigmapharm Labs Llc, Alvogen, and Glenmark Pharms Ltd. and is included in five 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. Six 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

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

SponsorPhase
Jerry Vockley, MD, PhDPhase 2
Acer Therapeutics Inc.Phase 2
Maastricht UniversityPhase 4

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
Endo Operations SODIUM PHENYLBUTYRATE sodium phenylbutyrate POWDER;ORAL 203918-001 Jun 15, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Operations SODIUM PHENYLBUTYRATE sodium phenylbutyrate TABLET;ORAL 204395-001 Apr 15, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sigmapharm Labs Llc SODIUM PHENYLBUTYRATE sodium phenylbutyrate POWDER;ORAL 202819-001 Mar 22, 2013 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alvogen SODIUM PHENYLBUTYRATE sodium phenylbutyrate TABLET;ORAL 090910-001 Nov 18, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glenmark Pharms Ltd SODIUM PHENYLBUTYRATE sodium phenylbutyrate TABLET;ORAL 216462-001 Nov 1, 2022 AB RX No No ⤷  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

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/002500
Treatment of chronic management of urea-cycle disorders.
Authorised no no no 2013-07-30
Immedica Pharma AB Ammonaps sodium phenylbutyrate EMEA/H/C/000219
Ammonaps 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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