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Last Updated: December 12, 2024

PHEBURANE Drug Patent Profile


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Which patents cover Pheburane, and when can generic versions of Pheburane launch?

Pheburane is a drug marketed by Medunik and is included in one NDA.

The generic ingredient in PHEBURANE 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 Pheburane

A generic version of PHEBURANE was approved as sodium phenylbutyrate by SIGMAPHARM LABS LLC on March 22nd, 2013.

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Summary for PHEBURANE
Drug patent expirations by year for PHEBURANE
Drug Prices for PHEBURANE

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Recent Clinical Trials for PHEBURANE

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SponsorPhase
Maastricht UniversityPhase 4

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Pharmacology for PHEBURANE

US Patents and Regulatory Information for PHEBURANE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medunik PHEBURANE sodium phenylbutyrate PELLETS;ORAL 216513-001 Jun 17, 2022 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

EU/EMA Drug Approvals for PHEBURANE

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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