Details for New Drug Application (NDA): 209203

NDA 209203 describes DUZALLO, 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 DUZALLO profile page.

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

Constraining patent/regulatory exclusivity:

8,546,436

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:	10,183,012	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:	8,003,681	Patent Expiration:	Aug 25, 2025	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	8,084,483	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

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