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DUZALLO Drug Profile
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» See Plans and PricingWhich 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-seven 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. Additional details are available on the allopurinol; lesinurad profile page.
US ANDA Litigation and Generic Entry Outlook for Duzallo
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 29, 2032. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for DUZALLO
| International Patents: | 197 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 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.
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 | Start Trial | ||||
| Ironwood Pharms Inc | DUZALLO | allopurinol; lesinurad | TABLET;ORAL | 209203-002 | Aug 18, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Ironwood Pharms Inc | DUZALLO | allopurinol; lesinurad | TABLET;ORAL | 209203-001 | 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 | ||||
| Ironwood Pharms Inc | DUZALLO | allopurinol; lesinurad | TABLET;ORAL | 209203-002 | 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 |
|---|---|---|
| South Africa | 201300055 | Start Trial |
| Luxembourg | 93169 | Start Trial |
| Portugal | 2582683 | Start Trial |
| Argentina | 073548 | Start Trial |
| Singapore | 183721 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DUZALLO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2135608 | PA2016024 | Lithuania | Start Trial | PRODUCT NAME: LESINURADAS; REGISTRATION NO/DATE: EU/1/15/1080 20160218 |
| 2217577 | 300970 | Netherlands | Start Trial | PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/18/1300 20180827 |
| 2217577 | CA 2019 00003 | Denmark | Start Trial | PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SALTS THEREOF; REG. NO/DATE: EU/1/18/1300 20180827 |
| 2135608 | 2016/033 | Ireland | Start Trial | PRODUCT NAME: (I)PRODUCT (I.E. ACTIVE INGREDIENT OR COMBINATION OF ACTIVE INGREDIENTS) FOR WHICH A CERTIFICATE IS REQUESTED:-LESINURAD, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/15/1080 20160218 |
| 2217577 | 122019000008 | Germany | Start Trial | PRODUCT NAME: DUZALLO - ALLOPURINOL / LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/18/1300 20180823 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
