FYARRO Drug Patent Profile
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When do Fyarro patents expire, and when can generic versions of Fyarro launch?
Fyarro is a drug marketed by Aadi and is included in one NDA. There are seven patents protecting this drug.
This drug has one hundred and sixty-seven patent family members in thirty-three countries.
The generic ingredient in FYARRO is sirolimus. There are twenty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fyarro
A generic version of FYARRO was approved as sirolimus by ZYDUS PHARMS on January 8th, 2014.
US Patents and Regulatory Information for FYARRO
FYARRO is protected by nine US patents and one FDA Regulatory Exclusivity.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aadi | FYARRO | sirolimus | POWDER;INTRAVENOUS | 213312-001 | Nov 22, 2021 | RX | Yes | Yes | 12,133,844 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Aadi | FYARRO | sirolimus | POWDER;INTRAVENOUS | 213312-001 | Nov 22, 2021 | RX | Yes | Yes | 11,497,737 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Aadi | FYARRO | sirolimus | POWDER;INTRAVENOUS | 213312-001 | Nov 22, 2021 | RX | Yes | Yes | 10,973,806 | ⤷ 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 FYARRO
See the table below for patents covering FYARRO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2010236382 | ⤷ Start Trial | |
| Brazil | PI1012525 | ⤷ Start Trial | |
| Canada | 2758913 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FYARRO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0648494 | C300055 | Netherlands | ⤷ Start Trial | PRODUCT NAME: SIROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT; NATL. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: CH CH/55243 20000926 |
| 0763039 | 18/2008 | Austria | ⤷ Start Trial | PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
| 0763039 | PA2008009,C0763039 | Lithuania | ⤷ Start Trial | PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
