Details for New Drug Application (NDA): 207988
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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: | ⤷ Get Started Free | 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: | ⤷ Get Started Free | Patent Expiration: | Aug 25, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Aug 17, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCTION OF SERUM URIC ACID LEVELS | ||||||||
Expired US Patents for NDA 207988
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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