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
*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 | 209203-002 | 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 | 209203-002 | 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 | ||||
| >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 |
|---|---|---|---|
| Montenegro | 01294 | NOVA JEDINJENJA I KOMPOZICIJE I METODE UPOTREBE (NOVEL COMPOUNDS AND COMPOSITIONS AND METHODS OF USE) | ⤷ Sign Up |
| Cyprus | 1118621 | ⤷ Sign Up | |
| Mexico | 2011002450 | COMPUESTOS, COMPOSICIONES Y MÉTODOS PARA UTILIZAR LOS MISMOS PARA MODULAR NIVELES DE ÁCIDO ÚRICO. (COMPOUNDS, COMPOSITIONS AND METHODS OF USING SAME FOR MODULATING URIC ACID LEVELS.) | ⤷ Sign Up |
| South Korea | 20110050708 | COMPOUNDS, COMPOSITIONS AND METHODS OF USING SAME FOR MODULATING URIC ACID LEVELS | ⤷ 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,C2135608 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LESINURADAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1080 20160218 |
| 2217577 | 1990005-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: COMBINATION OF LESINURAD OR A PHARMACEUTICA LLY ACCEPTABLE SALT THEREOF AND ALLOPURINOL; REG. NO/DATE: EU/18/1300 20180827 |
| 2217577 | 7/2019 | Austria | ⤷ Sign Up | PRODUCT NAME: ALLOPURINOL UND LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SALZE DAVON; REGISTRATION NO/DATE: EU/1/18/1300 20180827 |
| 2217577 | 132019000000023 | Italy | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
