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 |
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Withdrawn | no | no | no | 2018-08-23 | |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 |
---|---|---|---|
Poland | 2217577 | ⤷ Try a Trial | |
Serbia | 52632 | S-TRIAZOLIL ALFA-MERKAPTOACETANILIDA KAO INHIBITORI HIV REVERSNE TRANSKRIPTAZE (S-TRIAZOLYL ALPHA-MERCAPTOACETANILIDES AS INHIBITORS OF HIV REVERSE TRANSCRIPTASE) | ⤷ Try a Trial |
New Zealand | 595035 | Substituted diazole and triazole compounds and compositions and methods of use | ⤷ Try a Trial |
Brazil | 112013016982 | formas polimórficas de ácido 2-(5-bromo-4-(4-ciclopropilnaftalen-1-il)-4h-1,2,4-triazol-3-iltio)acético e usos destes | ⤷ Try a Trial |
Brazil | PI0514630 | alfa-mercaptoacetanilidas e s-triazolila como inibidores de transcriptase reversa de hiv | ⤷ Try a Trial |
Hong Kong | 1180337 | 調節血液尿酸水平的化合物 (COMPOUNDS USEFUL IN THE MODULATION OF BLOOD URIC ACID LEVELS) | ⤷ 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 |
---|---|---|---|---|
2217577 | 7/2019 | Austria | ⤷ Try a Trial | PRODUCT NAME: ALLOPURINOL UND LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SALZE DAVON; REGISTRATION NO/DATE: EU/1/18/1300 20180827 |
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 |
2135608 | CA 2016 00034 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LESINURAD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU1/15/1080 20160222 |
2135608 | C20160027 00203 | Estonia | ⤷ Try a Trial | PRODUCT NAME: LESINURAAD;REG NO/DATE: EU/1/15/1080 22.02.2016 |
2217577 | 132019000000023 | Italy | ⤷ Try a Trial | PRODUCT NAME: ALLOPURINOLO/LESINURAD, O UN LORO SALE FARMACEUTICAMENTE ACCETTABILE O LORO SALI FARMACEUTICAMENTE ACCETTABILI(DUZALLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1300, 20180827 |
2217577 | LUC00103 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OU UN/DES SEL(S) PHARMACEUTIQUEMENT ACCEPTABLE(S) DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1300 20180827 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |