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Febuxostat - Generic Drug Details

What are the generic sources for febuxostat and what is the scope of febuxostat freedom to operate?
Febuxostat is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. 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-five drug master file entries for febuxostat. Five suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for febuxostat

International Patents:	105
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	25
Suppliers / Packagers:	5
Bulk Api Vendors:	98
Clinical Trials:	57
Patent Applications:	352
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	febuxostat at DailyMed

Pharmacology for febuxostat

Drug Class	Xanthine Oxidase Inhibitor
Mechanism of Action	Xanthine Oxidase Inhibitors

Medical Subject Heading (MeSH) Categories for febuxostat

Gout Suppressants

Synonyms for febuxostat

060F537
101V0R1N2E
111GE013
144060-53-7
2-?[3-?CYANO-?4-?(2-?METHYLPROPOXY)PHENYL]-?4-?METHYL-?5-?THIAZOLECARBOXYLIC ACID
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
BCP9000679
BCPP000233
BDBM50320491
BQSJTQLCZDPROO-UHFFFAOYSA-N
BS-1018
C-23827
C16H16N2O3S
CAS-144060-53-7
CC-28363
CCG-213303
CHEBI:31596
CHEMBL1164729
CS-0403
CTK8B4748
D01206
D0A5SE
DB04854
DR001370
DSSTox_CID_28576
DSSTox_GSID_48650
DSSTox_RID_82848
DTXSID8048650
EN300-122360
F0847
FBX
FC0017
FD7322
Febric
februxostat
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
HE111675
HMS3264C20
HMS3655C03
HY-14268
J10392
KS-00000G8Y
LS-173202
MCULE-6974079178
MFCD00871598
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
TC-070914
TEI
Tei 6720
Tei-6720
TMX 67
TMX-67
TMX-67, Adenuric, Uloric, Febuxostat
TMX-67;Adenuric;Uloric
Tox21_113004
Tox21_113004_1
Uloric
Uloric (TN)
UNII-101V0R1N2E
Z1550648761
ZINC5423
Zurig

Tentative approvals for FEBUXOSTAT

Applicant	Application No.	Strength	Dosage Form
➤ Sign Up	➤ Sign Up	40MG	TABLET;ORAL
➤ Sign Up	➤ Sign Up	80MG	TABLET;ORAL
➤ Sign Up	➤ Sign Up	80MG	TABLET;ORAL

US Patents and Regulatory Information for febuxostat

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Glossary

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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		RX	Yes	No	➤ Sign Up	➤ Sign Up		Y		➤ Sign Up
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009		RX	Yes	Yes	➤ Sign Up	➤ Sign Up		Y		➤ Sign Up
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

International Patents for febuxostat

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Country	Document Number	Estimated Expiration
Croatia	P20000092	➤ Sign Up
Poland	200710	➤ Sign Up
South Korea	100221041	➤ Sign Up
Russian Federation	2198169	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for febuxostat

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0140037 00152	Estonia	➤ Sign Up	PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
C015/2010	Ireland	➤ Sign Up	SPC015/2010: 20101001, EXPIRES: 20230420
682	Luxembourg	➤ Sign Up	91682, EXPIRES: 20230421
2010 005, C 1020454	Lithuania	➤ Sign Up	PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description