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Last Updated: March 29, 2024

BUPHENYL Drug Patent Profile


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

Buphenyl is a drug marketed by Horizon Therap Us and is included in two NDAs.

The generic ingredient in BUPHENYL 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 Buphenyl

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

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Drug patent expirations by year for BUPHENYL
Drug Prices for BUPHENYL

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Recent Clinical Trials for BUPHENYL

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SponsorPhase
University of Alabama at BirminghamPhase 1/Phase 2
Children's Hospital of PhiladelphiaPhase 1/Phase 2
Johns Hopkins UniversityPhase 1/Phase 2

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Pharmacology for BUPHENYL

US Patents and Regulatory Information for BUPHENYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon Therap Us BUPHENYL sodium phenylbutyrate POWDER;ORAL 020573-001 Apr 30, 1996 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Horizon Therap Us BUPHENYL sodium phenylbutyrate TABLET;ORAL 020572-001 May 13, 1996 AB 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

Expired US Patents for BUPHENYL

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

EU/EMA Drug Approvals for BUPHENYL

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

Supplementary Protection Certificates for BUPHENYL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0579826 SPC/GB02/042 United Kingdom ⤷  Try a Trial PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422
1499331 SPC/GB13/034 United Kingdom ⤷  Try a Trial PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
0480717 98C0022 France ⤷  Try a Trial PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
1948158 16C0018 France ⤷  Try a Trial PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1912999 1490062-5 Sweden ⤷  Try a Trial PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
1856135 2090014-8 Sweden ⤷  Try a Trial PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE OR SOLVATE OF FOSTAMATINIB OR THE PH ARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
2822954 1890030-8 Sweden ⤷  Try a Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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