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.
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: | DISCN | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Dec 22, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 26, 2028 | Product 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 Trial | Patent Expiration: | Aug 25, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 17, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCTION OF SERUM URIC ACID LEVELS | ||||||||
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