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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 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-six drug master file entries for febuxostat. Four 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:	26
Suppliers / Packagers:	4
Bulk Api Vendors:	106
Clinical Trials:	61
Patent Applications:	354
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for febuxostat
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
		80MG	TABLET;ORAL
		40MG	TABLET;ORAL
		80MG	TABLET;ORAL

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

International Patents for febuxostat

Country	Document Number	Estimated Expiration
Iceland	9021
Slovakia	287946
Hong Kong	1118293
Cyprus	1115490

Supplementary Protection Certificates for febuxostat

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2010005	Lithuania		PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
/2010	Austria		PRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
5	Finland
C/GB10/019	United Kingdom		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.