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Last Updated: June 3, 2020

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ULORIC Drug Profile


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Which patents cover Uloric, and what generic alternatives are available?

Uloric is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in fifteen countries.

The generic ingredient in ULORIC is febuxostat. There are twenty-six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the febuxostat profile page.

US ANDA Litigation and Generic Entry Outlook for Uloric

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

  Start Trial

Drug patent expirations by year for ULORIC
Drug Prices for ULORIC

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Drug Sales Revenue Trends for ULORIC

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Recent Clinical Trials for ULORIC

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

SponsorPhase
Ai PengN/A
Contract Research Organization: USAPhase 2
Harbor Hospital LaboratoryPhase 2

See all ULORIC clinical trials

Recent Litigation for ULORIC

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 ULORIC litigation

Pharmacology for ULORIC
Synonyms for ULORIC
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
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 (TN)
UNII-101V0R1N2E
Z1550648761
ZINC000000005423
ZINC5423
Zurig
Paragraph IV (Patent) Challenges for ULORIC
Tradename Dosage Ingredient NDA Submissiondate
ULORIC TABLET;ORAL febuxostat 021856 2013-02-13

US Patents and Regulatory Information for ULORIC

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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 ULORIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1488790 C20140037 00152 Estonia   Start Trial PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
1020454 SPC015/2010 Ireland   Start Trial SPC015/2010: 20101001, EXPIRES: 20230420
1020454 CA 2010 00015 Denmark   Start Trial
1020454 385 Finland   Start Trial
1020454 19/2010 Austria   Start Trial PRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Moodys
McKinsey
Johnson and Johnson
Baxter
Dow

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.