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 | 209203-002 | 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 | 209203-001 | 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 | ||||
>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 |
---|---|---|---|
Australia | 2005280130 | S-triazolyl alpha-mercaptoacetanildes as inhibitors of HIV reverse transcriptase | ⤷ Sign Up |
Argentina | 073548 | COMPUESTOS DERIVADOS DE DIAZOL Y TRIAZOL, COMPOSICIONES Y USO DE LOS MISMOS PARA MODULAR LOS NIVELES DE ACIDO URICO | ⤷ Sign Up |
New Zealand | 581376 | Intermediates useful in the synthesis of S-triazolyl alpha-mercaptoacetanildes for inhibition of HIV reverse transcriptase | ⤷ Sign Up |
China | 103819419 | Compounds, compositions and methods of using same for modulating uric acid levels | ⤷ Sign Up |
South Korea | 101411806 | ⤷ 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 |
---|---|---|---|---|
2135608 | PA2016024 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LESINURADAS; REGISTRATION NO/DATE: EU/1/15/1080 20160218 |
2135608 | 2016C/039 | Belgium | ⤷ Sign Up | PRODUCT NAME: LESINURAD, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/15/1080 20160222 |
2135608 | SPC/GB16/045 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: LESINURAD; REGISTERED: UK EU/1/15/1080 20160222 |
2135608 | PA2016024,C2135608 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LESINURADAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1080 20160218 |
2217577 | 2019C/502 | Belgium | ⤷ Sign Up | PRODUCT NAME: DUZALLO - ALLOPURINOL / LESINURAD OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN DE SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/18/1300 20180827 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |