Last Updated: August 3, 2026

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.

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Summary for FYARRO
International Patents:167
US Patents:7
Applicants:1
NDAs:1

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

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

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