Allopurinol; lesinurad - Generic Drug Details
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What are the generic sources for allopurinol; lesinurad and what is the scope of freedom to operate?
Allopurinol; lesinurad
is the generic ingredient in one branded drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Allopurinol; lesinurad has two hundred patent family members in forty-two countries.
Summary for allopurinol; lesinurad
International Patents: | 200 |
US Patents: | 9 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Clinical Trials: | 7 |
DailyMed Link: | allopurinol; lesinurad at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for allopurinol; lesinurad
Generic Entry Date for allopurinol; lesinurad*:
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.
Recent Clinical Trials for allopurinol; lesinurad
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ardea Biosciences, Inc. | Phase 1 |
Ardea Biosciences, Inc. | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for allopurinol; lesinurad
US Patents and Regulatory Information for allopurinol; lesinurad
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ironwood Pharms Inc | DUZALLO | allopurinol; lesinurad | TABLET;ORAL | 209203-001 | Aug 18, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ironwood Pharms Inc | DUZALLO | allopurinol; lesinurad | TABLET;ORAL | 209203-001 | Aug 18, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ironwood Pharms Inc | DUZALLO | allopurinol; lesinurad | TABLET;ORAL | 209203-002 | Aug 18, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Ironwood Pharms Inc | DUZALLO | allopurinol; lesinurad | TABLET;ORAL | 209203-002 | Aug 18, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for allopurinol; lesinurad
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Grunenthal GmbH | Duzallo | allopurinol, lesinurad | EMEA/H/C/004412 Duzallo is indicated in adults for the treatment of hyperuricaemia in gout patients who have not achieved target serum uric acid levels with an adequate dose of allopurinol alone. |
Withdrawn | no | no | no | 2018-08-23 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for allopurinol; lesinurad
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 2135608 | ⤷ Sign Up | |
Croatia | P20170187 | ⤷ Sign Up | |
France | 16C0031 | ⤷ Sign Up | |
South Africa | 201003769 | NOVEL COMPOUNDS AND COMPOSITIONS AND METHODS OF USE | ⤷ Sign Up |
South Korea | 20130105902 | POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO)ACETIC ACID AND USES THEREOF | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for allopurinol; lesinurad
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2217577 | C20190007 00276 | Estonia | ⤷ Sign Up | PRODUCT NAME: ALLOPURINOOL/LESINURAAD;REG NO/DATE: EU/1/18/1300 27.08.2018 |
2135608 | 122016000060 | Germany | ⤷ Sign Up | PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 20160218 |
2135608 | SPC/GB16/045 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: LESINURAD; REGISTERED: UK EU/1/15/1080 20160222 |
2135608 | 93169 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LESINURAD , OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION DATE: 20160222 |
2217577 | CR 2019 00003 | Denmark | ⤷ Sign Up | PRODUCT NAME: ALLOPURINOL AND LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1300 20180827 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |