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Profile for Tradename: ULORIC

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

This drug has eigthy-eight patent family members in thirty-five countries.

The generic ingredient in ULORIC is febuxostat. There are twenty drug master file entries for this compound. Four suppliers are listed 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 list12

Pharmacology for Tradename: ULORIC

Clinical Trials for: ULORIC

Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
Status: Completed Condition: Gout

The Blood Pressure Effects of Febuxostat in Patients Previously Treated With Allopurinol: A Pilot Study
Status: Terminated Condition: Blood Pressure; Gout

Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout
Status: Completed Condition: Gout

Effects of Febuxostat on Adipokines and Kidney Disease in Diabetic Chronic Kidney Disease
Status: Completed Condition: Chronic Kidney Disease; Diabetes

Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment
Status: Completed Condition: Renal Impairment

Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment
Status: Completed Condition: Gout; Moderate Renal Impairment

Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia
Status: Completed Condition: Gout; Hyperuricemia

Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
Status: Completed Condition: Gout

Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010
Status: Completed Condition: Gout

Efficacy and Safety of Oral Febuxostat in Participants With Gout
Status: Completed Condition: Gout

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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 Publication Date
China102020617Apr 20, 2011
European Patent Office2404910Jan 11, 2012
Australia2003220909Sep 18, 2008
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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