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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;ORAL021856-001Feb 13, 20095,614,520<disabled>
Takeda Pharms Usa
ULORIC
febuxostat
TABLET;ORAL021856-002Feb 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
Brazil9906539<disabled in preview>
Slovakia287946<disabled in preview>
Indonesia25775<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ULORIC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010005,C1020454Lithuania<disabled>PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
0140037 00152Estonia<disabled>PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
5Finland<disabled>
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