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Last Updated: April 4, 2020

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BUPHENYL Drug 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 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. Three 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 ALVOGEN on November 18th, 2011.

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

See all BUPHENYL clinical trials

Pharmacology for BUPHENYL
Synonyms for BUPHENYL
1716-12-7
4-PB
4-Phenylbutyrate, Na
4-phenylbutyric acid sodium
4-Phenylbutyric Acid Sodium Salt
4-phenylbutyric acid, sodium salt
4PBA
A4107
AB0013057
AK-93011
AKOS006344763
AKOS015967141
Ammonaps
Ammonapse
AMX-0035 COMPONENT SODIUM PHENYLBUTYRATE
AMX0035 COMPONENT SODIUM PHENYLBUTYRATE
AS-13914
Benzenebutanoic acid, sodium salt
BG0653
Buphenyl (TN)
C10H11NaO2
C10H12O2.Na
CAS-1716-12-7
CCG-213730
CHEBI:75316
CHEMBL1746
CMK-304
CS-1397
CS0031
CTK4F8662
D05868
DSSTox_CID_20948
DSSTox_GSID_40948
DSSTox_RID_79606
DTXSID7040948
EL-532
FT-0619402
H454
HMS2089B22
HMS3269N07
HMS3413B10
HMS3652K18
HMS3677B10
HY-15654
J-010746
J-524277
KS-00000H29
LS-173641
Lunaphen
M-2491
NaPb
NCGC00018113-03
NCGC00018113-07
NCGC00167830-01
NSC 657802
NSC-657802
NT6K61736T
Phenylbutyric acid sodium salt
Q7553358
s4125
SCHEMBL125792
sodium 4-phenylbutanoate
Sodium 4-phenylbutyrate
Sodium 4-Phenylbutyrate (Buphenyl)
Sodium 4-phenylbutyrate;TriButyrate
Sodium phenyl butirate
SODIUM PHENYLBUTYRATE
Sodium phenylbutyrate (JAN/USAN)
Sodium phenylbutyrate [USAN:BAN]
Sodium phenylbutyrate [USAN]
Sodium phenylbutyrate, >=98% (HPLC)
Sodium phenylbutyrate, European Pharmacopoeia (EP) Reference Standard
Sodium phenylbutyrate, United States Pharmacopeia (USP) Reference Standard
sodium-4-phenylbutyrate
sodium-phenylbutyrate
sodium;4-phenylbutanoate
SW219199-1
Tox21_110826
Tox21_110826_1
TriButyrate
UNII-NT6K61736T
VP-101
VPZRWNZGLKXFOE-UHFFFAOYSA-M

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
2203431 2015/009 Ireland   Start Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
2932970 18C1043 France   Start Trial PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
0145340 99C0005 Belgium   Start Trial PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0579826 02C0041 France   Start Trial PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
1259550 08C0052 France   Start Trial PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
2203431 CR 2015 00014 Denmark   Start Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Moodys
Boehringer Ingelheim
Merck
Mallinckrodt

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