➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Merck
Express Scripts
Harvard Business School
AstraZeneca

Last Updated: February 28, 2021

DrugPatentWatch Database Preview

BUPHENYL Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

Buphenyl is a drug marketed by Horizon Therap 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. Two suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.

US ANDA 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.

  Start Trial

Drug patent expirations by year for BUPHENYL
Drug Prices for BUPHENYL

See drug prices for BUPHENYL

Recent Clinical Trials for BUPHENYL

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

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

See all BUPHENYL clinical trials

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

Supplementary Protection Certificates for BUPHENYL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1856135 LUC00153 Luxembourg   Start Trial 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
2203431 15C0013 France   Start Trial PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
0290047 SPC/GB97/078 United Kingdom   Start Trial PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
1912999 14C0076 France   Start Trial PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Moodys
Boehringer Ingelheim
Merck
Mallinckrodt

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.