Details for New Drug Application (NDA): 209203
✉ Email this page to a colleague
The generic ingredient in DUZALLO is allopurinol; lesinurad. There are twenty-two drug master file entries for this compound. Additional details are available on the allopurinol; lesinurad profile page.
Summary for 209203
Tradename: | DUZALLO |
Applicant: | Ironwood Pharms Inc |
Ingredient: | allopurinol; lesinurad |
Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209203
Generic Entry Date for 209203*:
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;200MG | ||||
Approval Date: | Aug 18, 2017 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | 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 MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 25, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 17, 2029 | 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 MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE |
Complete Access Available with Subscription