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Last Updated: November 7, 2024

SODIUM PHENYLBUTYRATE - Generic Drug Details


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What are the generic sources for sodium phenylbutyrate and what is the scope of patent protection?

Sodium phenylbutyrate is the generic ingredient in five branded drugs marketed by Acer, Medunik, Horizon Therap Us, Endo Operations, Sigmapharm Labs Llc, Alvogen, Glenmark Pharms Ltd, and Amylyx, and is included in ten NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium phenylbutyrate has twenty-five patent family members in twenty countries.

There are four drug master file entries for sodium phenylbutyrate. Six suppliers are listed for this compound.

Summary for SODIUM PHENYLBUTYRATE
International Patents:25
US Patents:8
Tradenames:5
Applicants:8
NDAs:10
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 6
Raw Ingredient (Bulk) Api Vendors: 97
Clinical Trials: 39
Patent Applications: 2,582
What excipients (inactive ingredients) are in SODIUM PHENYLBUTYRATE?SODIUM PHENYLBUTYRATE excipients list
DailyMed Link:SODIUM PHENYLBUTYRATE at DailyMed
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
Amylyx RELYVRIO sodium phenylbutyrate; taurursodiol FOR SUSPENSION;ORAL 216660-001 Sep 29, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Horizon Therap Us BUPHENYL sodium phenylbutyrate POWDER;ORAL 020573-001 Apr 30, 1996 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Acer OLPRUVA sodium phenylbutyrate FOR SUSPENSION;ORAL 214860-003 Dec 22, 2022 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Acer OLPRUVA sodium phenylbutyrate FOR SUSPENSION;ORAL 214860-006 Dec 22, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Amylyx RELYVRIO sodium phenylbutyrate; taurursodiol FOR SUSPENSION;ORAL 216660-001 Sep 29, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 SODIUM PHENYLBUTYRATE

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 ⤷  Sign Up ⤷  Sign Up
Horizon Therap Us BUPHENYL sodium phenylbutyrate TABLET;ORAL 020572-001 May 13, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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

International Patents for SODIUM PHENYLBUTYRATE

Country Patent Number Title Estimated Expiration
Serbia 63383 SASTAVI PRIJATNOG UKUSA KOJI UKLJUČUJU NATRIJUM FENILBUTIRAT I NJIHOVA PRIMENA (PALATABLE COMPOSITIONS INCLUDING SODIUM PHENYLBUTYRATE AND USES THEREOF) ⤷  Sign Up
Japan 7136763 ⤷  Sign Up
European Patent Office 3429559 COMPOSITIONS AU GOÛT AGRÉABLE COMPRENANT DU PHÉNYLBUTYRATE DE SODIUM ET LEURS UTILISATIONS (PALATABLE COMPOSITIONS INCLUDING SODIUM PHENYLBUTYRATE AND USES THEREOF) ⤷  Sign Up
Israel 296490 הרכבים טעימים הכוללים נתרן פנילביוטירייט ושימושים עבורם (Palatable compositions including sodium phenylbutyrate and uses thereof) ⤷  Sign Up
Slovenia 3429559 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SODIUM PHENYLBUTYRATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1856135 2020/017 Ireland ⤷  Sign Up PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTRATION NO/DATE: EU/1/19/1405 20200113
1948158 16C0018 France ⤷  Sign Up 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
1259550 08C0052 France ⤷  Sign Up PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1856135 LUC00153 Luxembourg ⤷  Sign Up PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
0290047 97C0108 Belgium ⤷  Sign Up PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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