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: November 17, 2019

DrugPatentWatch Database Preview

DUZALLO Drug Profile

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Which patents cover Duzallo, and what generic alternatives are available?

Duzallo is a drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and ninety-four patent family members in forty-one countries.

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 DUZALLO
Drug patent expirations by year for DUZALLO
Drug Prices for DUZALLO

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Generic Entry Opportunity Date for DUZALLO
Generic Entry Date for DUZALLO*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for DUZALLO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ironwood Pharms Inc DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-001 Aug 18, 2017 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Ironwood Pharms Inc DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-002 Aug 18, 2017 DISCN Yes No   Start Trial   Start Trial   Start Trial
Ironwood Pharms Inc DUZALLO allopurinol; lesinurad TABLET;ORAL 209203-001 Aug 18, 2017 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for DUZALLO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2135608 C20160027 00203 Estonia   Start Trial PRODUCT NAME: LESINURAAD;REG NO/DATE: EU/1/15/1080 22.02.2016
2217577 LUC00103 Luxembourg   Start Trial PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OU UN/DES SEL(S) PHARMACEUTIQUEMENT ACCEPTABLES(S); AUTHORISATION NUMBER AND DATE: EU/1/18/1300 20180827
2135608 CR 2016 00034 Denmark   Start Trial PRODUCT NAME: LESINURAD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU1/15/1080 20160222
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Baxter
Mallinckrodt
Express Scripts
AstraZeneca

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