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Generated: May 25, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207988

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NDA 207988 describes ZURAMPIC, which is a drug marketed by Ironwood Pharms Inc and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the ZURAMPIC profile page.

The generic ingredient in ZURAMPIC is lesinurad. One supplier is listed for this compound. Additional details are available on the lesinurad profile page.
Summary for 207988
Tradename:ZURAMPIC
Applicant:Ironwood Pharms Inc
Ingredient:lesinurad
Patents:9
Generic Entry Opportunity Date for 207988
Generic Entry Date for 207988*:
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: 207988
Suppliers and Packaging for NDA: 207988
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZURAMPIC lesinurad TABLET;ORAL 207988 NDA Ironwood Pharmaceuticals, Inc. 70785-011 70785-011-05 5 TABLET, FILM COATED in 1 BOTTLE (70785-011-05)
ZURAMPIC lesinurad TABLET;ORAL 207988 NDA Ironwood Pharmaceuticals, Inc. 70785-011 70785-011-30 30 TABLET, FILM COATED in 1 BOTTLE (70785-011-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Dec 22, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 22, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Nov 26, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A XANTHINE OXIDASE INHIBITOR ALONE
Patent:➤ Try a Free TrialPatent Expiration:Aug 25, 2025Product Flag?Substance Flag?YDelist Request?

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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. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.