You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

PHEBURANE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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.

  Try a Trial

Drug patent expirations by year for PHEBURANE
Drug Prices for PHEBURANE

See drug prices for PHEBURANE

Recent Clinical Trials for PHEBURANE

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

SponsorPhase
Maastricht UniversityPhase 4

See all PHEBURANE clinical trials

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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

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.