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Last Updated: November 22, 2024

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. There are nine patents protecting this drug. Additional details are available on the ZURAMPIC profile page.

The generic ingredient in ZURAMPIC is lesinurad. Additional details are available on the lesinurad profile page.
Summary for 207988
Tradename:ZURAMPIC
Applicant:Ironwood Pharms Inc
Ingredient:lesinurad
Patents:9
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG
Approval Date:Dec 22, 2015TE:RLD:Yes
Patent:⤷  Sign UpPatent 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:⤷  Sign UpPatent Expiration:Aug 25, 2025Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Aug 17, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION OF SERUM URIC ACID LEVELS

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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 verification 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.