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Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021856

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NDA 021856 describes ULORIC, which 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. Additional details are available on the ULORIC profile page.

The generic ingredient in ULORIC is febuxostat. There are twenty-six 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 021856
Tradename:ULORIC
Applicant:Takeda Pharms Usa
Ingredient:febuxostat
Patents:5
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021856
Generic Entry Date for 021856*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021856
Mechanism of ActionXanthine Oxidase Inhibitors
Medical Subject Heading (MeSH) Categories for 021856
Suppliers and Packaging for NDA: 021856
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULORIC febuxostat TABLET;ORAL 021856 NDA Rebel Distributors Corp 21695-516 21695-516-30 30 TABLET in 1 BOTTLE (21695-516-30)
ULORIC febuxostat TABLET;ORAL 021856 NDA Aphena Pharma Solutions - Tennessee, LLC 43353-305 43353-305-60 90 TABLET in 1 BOTTLE (43353-305-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Feb 13, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 15, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDIES ON PATIENTS WITH SEVERE RENAL IMPAIRMENT
Patent:➤ Sign UpPatent Expiration:Mar 25, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:CHRONIC MANAGEMENT OF HYPERURICEMIA IN PATIENTS WITH GOUT. NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA
Patent:➤ Sign UpPatent Expiration:Jun 18, 2019Product Flag?Substance Flag?YDelist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

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