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ULORIC Drug Profile

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Uloric is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from five suppliers. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-nine patent family members in thirty-five countries.

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

Summary for Tradename: ULORIC

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list5

Pharmacology for Tradename: ULORIC

Clinical Trials for: ULORIC

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
ULORIC
febuxostat
TABLET;ORAL021856-001Feb 13, 2009RXNo5,614,520<disabled>YY <disabled>
Takeda Pharms Usa
ULORIC
febuxostat
TABLET;ORAL021856-002Feb 13, 2009RXYes8,372,872<disabled> <disabled>
Takeda Pharms Usa
ULORIC
febuxostat
TABLET;ORAL021856-001Feb 13, 2009RXNo7,361,676<disabled>Y <disabled>
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Expired Patents for Tradename: ULORIC

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
ULORIC
febuxostat
TABLET;ORAL021856-002Feb 13, 20095,614,520<disabled>
Takeda Pharms Usa
ULORIC
febuxostat
TABLET;ORAL021856-001Feb 13, 20095,614,520<disabled>
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Paragraph IV activity for: ULORIC

Drugname Dosage Strength RLD Submissiondate
febuxostatTablets40 mg and 80 mgUloric2/13/2013

International Patent Family for Tradename: ULORIC

Country Document Number Estimated Expiration
China103298466<disabled in preview>
Poland200710<disabled in preview>
Iceland9022<disabled in preview>
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Supplementary Protection Certificates for Tradename: ULORIC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0140037 00152Estonia<disabled>PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
2010 005, C 1020454Lithuania<disabled>PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
682Luxembourg<disabled>91682, EXPIRES: 20230421
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