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ZURAMPIC Drug Profile
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» See Plans and PricingWhich patents cover Zurampic, and what generic alternatives are available?
Zurampic 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 ZURAMPIC is lesinurad. One supplier is listed for this compound. Additional details are available on the lesinurad profile page.
US ANDA Litigation and Generic Entry Outlook for Zurampic
Zurampic was eligible for patent challenges on December 22, 2019.
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 ZURAMPIC
| International Patents: | 197 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 68 |
| Patent Applications: | 69 |
| Drug Prices: | Drug price information for ZURAMPIC |
| DailyMed Link: | ZURAMPIC at DailyMed |
Generic Entry Opportunity Date for ZURAMPIC
Generic Entry Date for ZURAMPIC*:
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 ZURAMPIC
| Drug Class | Urate Transporter 1 Inhibitor |
| Mechanism of Action | Urate Transporter 1 Inhibitors Cytochrome P450 3A Inducers |
US Patents and Regulatory Information for ZURAMPIC
| 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 | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ironwood Pharms Inc | ZURAMPIC | lesinurad | TABLET;ORAL | 207988-001 | Dec 22, 2015 | 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 ZURAMPIC
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1112221 | Start Trial |
| Brazil | PI0918586 | Start Trial |
| Singapore | 190902 | Start Trial |
| Spain | 2670700 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ZURAMPIC
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 2217577 | C201930004 | Spain | Start 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 |
| 2135608 | C02135608/01 | Switzerland | Start Trial | PRODUCT NAME: LESINURAD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65925 07.04.2017 |
| 2135608 | 132016000081719 | Italy | Start Trial | PRODUCT NAME: LESINURAD, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZURAMPIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1080, 20160222 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
