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Last Updated: November 2, 2024

FYARRO Drug Patent Profile


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Which patents cover Fyarro, and what generic alternatives are available?

Fyarro is a drug marketed by Aadi and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and fifty patent family members in thirty-two countries.

The generic ingredient in FYARRO is sirolimus. There are twenty-one drug master file entries for this compound. Eighteen 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:150
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 68
Clinical Trials: 1
Patent Applications: 2,713
Drug Prices: Drug price information for FYARRO
What excipients (inactive ingredients) are in FYARRO?FYARRO excipients list
DailyMed Link:FYARRO at DailyMed
Drug patent expirations by year for FYARRO
Drug Prices for FYARRO

See drug prices for FYARRO

Recent Clinical Trials for FYARRO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Mirati Therapeutics Inc.Phase 1/Phase 2
Aadi Bioscience, Inc.Phase 1/Phase 2

See all FYARRO clinical trials

Pharmacology for FYARRO

US Patents and Regulatory Information for FYARRO

FYARRO is protected by six US patents and two FDA Regulatory Exclusivities.

Patents protecting FYARRO

Prion free nanoparticle compositions and methods of making thereof
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Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug
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Methods of treating epithelioid cell tumors comprising administering a composition comprising nanoparticles comprising an mTOR inhibitor and an albumin
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Patented Use: TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC MALIGNANT PERIVASCULAR EPITHELIOID CELL TUMOR (PECOMA) WITH A DOSE BETWEEN ABOUT 56 MG/M2 AND ABOUT 100 MG/M2 ADMINISTERED ON DAYS 1 AND 8 OF A 21-DAY CYCLE


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Nanoparticle comprising rapamycin and albumin as anticancer agent
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Patented Use: TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC MALIGNANT PERIVASCULAR EPITHELIOID CELL TUMOR (PECOMA)

FDA Regulatory Exclusivity protecting FYARRO

NEW PRODUCT
Exclusivity Expiration: ⤷  Sign Up

FOR THE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC MALIGNANT PERIVASCULAR EPITHELIOID CELL TUMOR (PECOMA)
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aadi FYARRO sirolimus POWDER;INTRAVENOUS 213312-001 Nov 22, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aadi FYARRO sirolimus POWDER;INTRAVENOUS 213312-001 Nov 22, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for FYARRO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pfizer Europe MA EEIG Rapamune sirolimus EMEA/H/C/000273
Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued., , Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.,
Authorised no no no 2001-03-13
Plusultra pharma GmbH Hyftor sirolimus EMEA/H/C/005896
Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.
Authorised no no yes 2023-05-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for FYARRO

See the table below for patents covering FYARRO around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2008109163 ⤷  Sign Up
European Patent Office 3417859 NANOPARTICULE COMPRENANT DE LA RAPAMYCINE ET DE L'ALBUMINE EN TANT QU'AGENT ANTI-CANCÉREUX (NANOPARTICLE COMPRISING RAPAMYCIN AND ALBUMIN AS ANTICANCER AGENT) ⤷  Sign Up
Portugal 3313401 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FYARRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0763039 18/2008 Austria ⤷  Sign Up PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0648494 C300055 Netherlands ⤷  Sign Up 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
0401747 25/2001 Austria ⤷  Sign Up PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: LI 5524301 20000926
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.