Allopurinol; lesinurad - Generic Drug Details
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What are the generic drug sources for allopurinol; lesinurad and what is the scope of patent protection?
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Withdrawn | no | no | no | 2018-08-23 | |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 |
|---|---|---|---|
| Austria | E540677 | ⤷ Try a Trial | |
| Montenegro | 01512 | S-triazolil alfa-merkaptoacetanilida kao inhibitori HIV reversne transkriptaze (S-triazolyl alpha-mercaptoacetanilides as inhibitors of HIV reverse transcriptase) | ⤷ Try a Trial |
| Australia | 2012203172 | Novel compounds and compositions and methods of use | ⤷ Try a Trial |
| Croatia | P20140950 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2010028189 | ⤷ Try a Trial | |
| Spain | 2614914 | ⤷ Try a Trial | |
| Eurasian Patent Organization | 014737 | S-ТРИАЗОЛИЛ-α-МЕРКАПТОАЦЕТАНИЛИДЫ В КАЧЕСТВЕ ИНГИБИТОРА ОБРАТНОЙ ТРАНСКРИПТАЗЫ ВИЧ (S-TRIAZOLYL α-MERCAPTOACETANILDES AS INHIBITORS OF HIV REVERSE TRANSCRIPTASE) | ⤷ 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 | PA2016024,C2135608 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LESINURADAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1080 20160218 |
| 2135608 | 132016000081719 | Italy | ⤷ Try a Trial | PRODUCT NAME: LESINURAD, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZURAMPIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1080, 20160222 |
| 2582683 | 2019008 | Norway | ⤷ Try a Trial | PRODUCT NAME: ALLOPURINOL/LESINURAD ELLER ET FARMASOEYTISK AKSEPTERBART SALT ELLER SALTER DERAV; REG. NO/DATE: EU/1/18/1300/001-004 20180904 |
| 2217577 | 19C1004 | France | ⤷ Try a Trial | PRODUCT NAME: ALLOPURINOL/LESINURAD OU UN/DES SEL(S) PHARMACEUTIQUEMENT ACCEPTABLE(S) DE CELUI-CI; REGISTRATION NO/DATE: EU/1/18/1300 20180827 |
| 2135608 | C02135608/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: LESINURAD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65925 07.04.2017 |
| 2217577 | C201930004 | Spain | ⤷ Try a Trial | PRODUCT NAME: ALOPURINOL + LESINURAD; NATIONAL AUTHORISATION NUMBER: EU/1/18/1300; DATE OF AUTHORISATION: 20180823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1300; DATE OF FIRST AUTHORISATION IN EEA: 20180823 |
| 2217577 | CR 2019 00003 | Denmark | ⤷ Try a Trial | 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 |
