Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

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BUPHENYL Drug Profile

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When do Buphenyl patents expire, and what generic alternatives are available?

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 launched as sodium phenylbutyrate by ALVOGEN on December 14th, 2019.

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
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
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 (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
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 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

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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 verifification 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.