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Last Updated: May 30, 2020

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FEBUXOSTAT Drug Profile


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US ANDA Litigation and Generic Entry Outlook for Febuxostat

A generic version of FEBUXOSTAT was approved as febuxostat by ALEMBIC PHARMS LTD on July 1st, 2019.

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Drug patent expirations by year for FEBUXOSTAT
Drug Prices for FEBUXOSTAT

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Recent Clinical Trials for FEBUXOSTAT

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

SponsorPhase
Jiangsu HengRui Medicine Co., Ltd.Phase 2
Arthrosi TherapeuticsPhase 2
Shenzhen Traditional Chinese Medicine HospitalN/A

See all FEBUXOSTAT clinical trials

Recent Litigation for FEBUXOSTAT

Identify potential future generic entrants

District Court Litigation
Case NameDate
Teijin Limited v. Alkem Laboratories Limited2019-04-26
Teijin Limited v. Torrent Pharmaceuticals Ltd.2018-07-02
Teijin Limited v. MSN Laboratories Private Ltd.2018-06-14

See all FEBUXOSTAT litigation

Pharmacology for FEBUXOSTAT
Medical Subject Heading (MeSH) Categories for FEBUXOSTAT
Synonyms for FEBUXOSTAT
060F537
101V0R1N2E
111GE013
144060-53-7
2-(3-Cyano-4-(2-methylpropoxy)phenyl)-4-methylthiazole-5-carboxylic acid
2-(3-Cyano-4-isobutoxy-phenyl)-4-me
2-(3-CYANO-4-ISOBUTOXY-PHENYL)-4-METHYL-5-THIAZOLE-CARBOXYLIC ACID
2-(3-cyano-4-isobutoxyphenyl)-4-methyl- 1,3-thiazole-5-carboxylic acid
2-(3-Cyano-4-isobutoxyphenyl)-4-methyl-5-thiazolecarboxylic acid
2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid
2-(3-cyano-4-isobutyloxy)-phenyl-4-methyl-5-thiazolecarboxylic acid
2-[3-cyano-4-(2-methylpropoxy)phenyl]-4-methyl-1,3-thiazole-5-carboxylic acid
2-[3-cyano-4-(2-methylpropoxy)phenyl]-4-methyl-5-thiazolecarboxylic acid
2-[3-Cyano-4-isobutoxyphenyl]-4-methylthiazole-5-carboxylic acid
5-Thiazolecarboxylic acid, 2-(3-cyano-4-(2-methylpropoxy)phenyl)-4-methyl-
5-Thiazolecarboxylic acid, 2-[3-cyano-4-(2-methylpropoxy)phenyl]-4-methyl-
AB0005158
AB01274796_02
AB01274796_03
AB01274796-01
AB2000143
ABP000399
AC-425
ACT06289
Adenuric
AK-83533
AKOS015841695
AM20090760
ANW-46040
API0004334
BB_SC-12106
BBL036503
BCP02342
BCP9000679
BCPP000233
BDBM50320491
BQSJTQLCZDPROO-UHFFFAOYSA-N
BRD-K48367671-001-01-8
BS-1018
C-23827
C16H16N2O3S
CAS-144060-53-7
CC-28363
CCG-213303
CHEBI:31596
CHEMBL1164729
CS-0403
CTK8B4748
D01206
DB04854
Donifoxate
DSSTox_CID_28576
DSSTox_GSID_48650
DSSTox_RID_82848
DTXSID8048650
EN300-122360
F0847
FD7322
Febric
Febuday
Feburic
Feburic (TN)
Febuxostat (JAN/USAN/INN)
Febuxostat (Uloric)
Febuxostat [USAN:INN:BAN]
Febuxostat [USAN]
Febuxostat, >=98% (HPLC)
Febuxostat,Uloric, TMX-67
Febuxostat(TEI 6720)
Febuxostat(Uloric)
Febuxostat(Uloric) /
Febuxostatum
FT-0081351
FT-0601639
Goturic
Goutex
GTPL6817
HMS3264C20
HMS3655C03
HMS3743I09
HY-14268
J10392
KS-00000G8Y
LS-173202
MCULE-6974079178
MLS004774136
MLS006011568
MX-67
NCGC00182059-02
NCGC00182059-03
NSC-758874
NSC758874
PB33929
Pharmakon1600-01504286
Q-100164
Q-4339
Q417296
RTC-070914
S033
S1547
SC-20178
SCHEMBL249339
SMR002529566
SR-01000940023
SR-01000940023-2
ST24027508
STL559020
SW219283-1
TC-070914
Tei 6720
Tei-6720
thyl-thiazole-5-carboxylic acid
TMX 67
TMX-67
TMX-67;Adenuric;Uloric
Tox21_113004
Tox21_113004_1
Uloric
Uloric (TN)
UNII-101V0R1N2E
Z1550648761
ZINC000000005423
ZINC5423
Zurig
Paragraph IV (Patent) Challenges for FEBUXOSTAT
Tradename Dosage Ingredient NDA Submissiondate
ULORIC TABLET;ORAL febuxostat 021856 2013-02-13

US Patents and Regulatory Information for FEBUXOSTAT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic Pharms Ltd FEBUXOSTAT febuxostat TABLET;ORAL 205421-001 Jul 1, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Msn FEBUXOSTAT febuxostat TABLET;ORAL 210461-001 Dec 30, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma FEBUXOSTAT febuxostat TABLET;ORAL 205414-002 Oct 15, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm FEBUXOSTAT febuxostat TABLET;ORAL 205467-002 Jul 1, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Msn FEBUXOSTAT febuxostat TABLET;ORAL 210461-002 Dec 30, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd FEBUXOSTAT febuxostat TABLET;ORAL 205421-002 Jul 1, 2019 AB RX No No   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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Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
Johnson and Johnson
McKinsey
Colorcon
McKesson

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.