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DUZALLO Drug Profile
Which patents cover Duzallo, and what generic alternatives are available?
Duzallo is a drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this drug.
This drug has one hundred and ninety-four patent family members in forty-one countries.
The generic ingredient in DUZALLO is allopurinol; lesinurad. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the allopurinol; lesinurad profile page.
Summary for DUZALLO
| International Patents: | 194 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DUZALLO |
| DailyMed Link: | DUZALLO at DailyMed |
Generic Entry Opportunity Date for DUZALLO
Generic Entry Date for DUZALLO*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Pharmacology for DUZALLO
US Patents and Regulatory Information for DUZALLO
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Ironwood Pharms Inc | DUZALLO | allopurinol; lesinurad | TABLET;ORAL | 209203-002 | Aug 18, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Ironwood Pharms Inc | DUZALLO | allopurinol; lesinurad | TABLET;ORAL | 209203-001 | Aug 18, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for DUZALLO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2433633 | Start Trial |
| Cyprus | 1118621 | Start Trial |
| European Patent Office | 2328874 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DUZALLO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2135608 | C20160027 00203 | Estonia | Start Trial | PRODUCT NAME: LESINURAAD;REG NO/DATE: EU/1/15/1080 22.02.2016 |
| 2217577 | LUC00103 | Luxembourg | Start Trial | PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OU UN/DES SEL(S) PHARMACEUTIQUEMENT ACCEPTABLES(S); AUTHORISATION NUMBER AND DATE: EU/1/18/1300 20180827 |
| 2135608 | CR 2016 00034 | Denmark | Start Trial | PRODUCT NAME: LESINURAD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU1/15/1080 20160222 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
