ALLOPURINOL; LESINURAD - Generic Drug Details
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What are the generic drug 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 |
US Patents and Regulatory Information for ALLOPURINOL; LESINURAD
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Withdrawn | no | no | no | 2018-08-23 | |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 |
---|---|---|---|
Australia | 2008329673 | Novel compounds and compositions and methods of use | ⤷ Try a Trial |
Serbia | 57275 | TRETMAN GIHTA I HIPERURIKEMIJE (TREATMENT OF GOUT AND HYPERURICEMIA) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2007050087 | ⤷ Try a Trial | |
Brazil | PI0918584 | compostos, composicoes e metodos de uso dos mesmos para modulacao dos niveis de acido urico | ⤷ Try a Trial |
New Zealand | 601774 | Substituted diazole and triazole compounds and compositions and methods of use | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ALLOPURINOL; LESINURAD
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2135608 | 93169 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: LESINURAD , OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION DATE: 20160222 |
2135608 | CR 2016 00034 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LESINURAD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU1/15/1080 20160222 |
2217577 | PA2019003 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ALOPURINOLIS/LESINURADAS ARBA JO FRAMACINIU POZIURIU PRIIMTINA DRUSKA ARBA DRUSKOS; REGISTRATION NO/DATE: EU/1/18/1300 20180823 |
2217577 | 1990005-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: COMBINATION OF LESINURAD OR A PHARMACEUTICA LLY ACCEPTABLE SALT THEREOF AND ALLOPURINOL; REG. NO/DATE: EU/18/1300 20180827 |
2135608 | C 2016 027 | Romania | ⤷ Try a Trial | PRODUCT NAME: LESINURAD SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1080; DATE OF NATIONAL AUTHORISATION: 20160218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1080; DATE OF FIRST AUTHORISATION IN EEA: 20160218 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |