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Last Updated: November 18, 2019

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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 two branded drugs marketed by Horizon Therap, Par Pharm, Sigmapharm Labs Llc, and Alvogen, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are one thousand four hundred and seventy-two drug master file entries for sodium phenylbutyrate. Three suppliers are listed for this compound.

Recent Clinical Trials for sodium phenylbutyrate

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

SponsorPhase
Fondazione TelethonPhase 1/Phase 2
Amylyx Pharmaceuticals Inc.Phase 2
Alzheimer's AssociationPhase 2

See all sodium phenylbutyrate clinical trials

Pharmacology for sodium phenylbutyrate
Synonyms for sodium phenylbutyrate
1716-12-7
1821-12-1 (Parent)
4-PB
4-Phenylbutyrate, Na
4-phenylbutyric acid sodium
4-Phenylbutyric Acid Sodium Salt
4-phenylbutyric acid, sodium salt
4PBA
A4107
AB0013057
AC1L1JY9
AC1Q1V7N
AC1Q1V7P
AK-93011
AKOS006344763
AKOS015967141
Ammonaps
Ammonapse
AN-49757
AS-13914
Benzenebutanoic acid, sodium salt
BG0653
Buphenyl
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
HMS3652K18
HY-15654
I01-7248
IN1087
J-010746
J-524277
KS-00000H29
LS-173641
Lunaphen
M-2491
MolPort-003-986-518
NaPb
natrium-4-phenylbutanoat
NCGC00018113-03
NCGC00018113-07
NCGC00167830-01
NSC 657802
NT6K61736T
phenyl n-butyrate sodium salt
Phenylbutyric acid sodium salt
RL02207
s4125
SCHEMBL125792
sodium 4-phenylbutanoate
Sodium 4-phenylbutyrate
Sodium 4-Phenylbutyrate (Buphenyl)
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;4-phenylbutanoate
SW219199-1
TL8001350
Tox21_110826
Tox21_110826_1
TriButyrate
UNII-NT6K61736T
VP-101
VPZRWNZGLKXFOE-UHFFFAOYSA-M

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
Par Pharm SODIUM PHENYLBUTYRATE sodium phenylbutyrate POWDER;ORAL 203918-001 Jun 15, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm SODIUM PHENYLBUTYRATE sodium phenylbutyrate TABLET;ORAL 204395-001 Apr 15, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Sigmapharm Labs Llc SODIUM PHENYLBUTYRATE sodium phenylbutyrate POWDER;ORAL 202819-001 Mar 22, 2013 AB RX No No   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
Alvogen SODIUM PHENYLBUTYRATE sodium phenylbutyrate TABLET;ORAL 090910-001 Nov 18, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Horizon Therap BUPHENYL sodium phenylbutyrate POWDER;ORAL 020573-001 Apr 30, 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

Expired US Patents for sodium phenylbutyrate

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

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

Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
Baxter
Mallinckrodt
Moodys
Colorcon

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