Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209203

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NDA 209203 describes DUZALLO, which is a drug marketed by Ironwood Pharms Inc and is included in one NDA. It is available from one supplier. 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. One supplier is listed 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
Generic Entry Opportunity 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.

Suppliers and Packaging for NDA: 209203
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUZALLO allopurinol; lesinurad TABLET;ORAL 209203 NDA Ironwood Pharmaceuticals, Inc. 70785-021 70785-021-05 5 TABLET, FILM COATED in 1 BOTTLE (70785-021-05)
DUZALLO allopurinol; lesinurad TABLET;ORAL 209203 NDA Ironwood Pharmaceuticals, Inc. 70785-021 70785-021-30 30 TABLET, FILM COATED in 1 BOTTLE (70785-021-30)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG;200MG
Approval Date:Aug 18, 2017TE:RLD:Yes
Patent:  Start TrialPatent 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 MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
Patent:  Start TrialPatent Expiration:Aug 25, 2025Product Flag?Substance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Aug 17, 2029Product 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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