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Last Updated: October 20, 2019

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Febuxostat - Generic Drug Details

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What are the generic sources for febuxostat and what is the scope of freedom to operate?

Febuxostat is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Mylan, Sun Pharm, and Takeda Pharms Usa, and is included in four NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Febuxostat has one hundred and five patent family members in thirty-five countries.

There are twenty-six drug master file entries for febuxostat. Seven suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for febuxostat

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Recent Clinical Trials for febuxostat

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

SponsorPhase
Instituto Nacional de Cardiologia Ignacio ChavezPhase 3
Instituto Nacional de RehabilitacionPhase 3
Altasciences Company Inc.Phase 1

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

Generic filers with tentative approvals for FEBUXOSTAT
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial80MGTABLET;ORAL
  Start Trial  Start Trial40MGTABLET;ORAL
  Start Trial  Start Trial80MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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-METHYL-5-THIAZOLE-CARBOXYLIC ACID
2-(3-cyano-4-isobutoxy-phenyl)-4-methyl-thiazole-5-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-(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
AC1L33UC
ACT06289
Adenuric
Adenuric, Uloric , Febutaz
AK-83533
AKOS015841695
AM20090760
AN-608
ANW-46040
API0004334
BB_SC-12106
BC220527
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
DSSTox_CID_28576
DSSTox_GSID_48650
DSSTox_RID_82848
DTXSID8048650
EN300-122360
F0847
FC0017
FD7322
Febric
Feburic
Feburic (TN)
Febuxostat (JAN/USAN/INN)
Febuxostat (Uloric)
Febuxostat [USAN:INN:BAN]
Febuxostat [USAN]
Febuxostat, >=98% (HPLC)
Febuxostat,Uloric, TMX-67
Febuxostat;
Febuxostat(TEI 6720)
Febuxostat(Uloric) /
Febuxostatum
FT-0081351
FT-0601639
GTPL6817
HMS3264C20
HMS3655C03
HY-14268
J10392
KS-00000G8Y
LS-173202
MCULE-6974079178
MLS004774136
MLS006011568
MolPort-005-940-740
MX-67
NCGC00182059-02
NCGC00182059-03
NSC-758874
NSC758874
PB33929
Pharmakon1600-01504286
Q-100164
Q-4339
RP17652
RTC-070914
S033
S1547
SC-20178
SCHEMBL249339
SMR002529566
SR-01000940023
SR-01000940023-2
ST24027508
SW219283-1
TC-070914
TEI
Tei 6720
Tei-6720
TMX 67
TMX-67
TMX-67;Adenuric;Uloric
Tox21_113004
Tox21_113004_1
Uloric
Uloric (TN)
UNII-101V0R1N2E
Z1550648761
ZINC5423
Zurig

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
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 AB RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 AB RX Yes No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 AB RX Yes 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

Expired US Patents for febuxostat

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009   Start Trial   Start Trial
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009   Start Trial   Start Trial
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for febuxostat

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1020454 CR 2010 00015 Denmark   Start Trial PRODUCT NAME: FEBUXOSTAT; REG. NO/DATE: EU/1/08/447/001-004 20080421
1020454 SPC/GB10/019 United Kingdom   Start Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB10/019 GRANTED TO TEIJIN LIMITED IN RESPECT OF THE PRODUCT FEBUXOSTAT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6408 DATED 14/03/2012 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22/04/2023.
1020454 PA 2010 005, C 1020454 Lithuania   Start Trial PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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