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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 213312


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NDA 213312 describes FYARRO, which is a drug marketed by Aadi Sub and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the FYARRO profile page.

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.
Summary for 213312
Tradename:FYARRO
Applicant:Aadi Sub
Ingredient:sirolimus
Patents:7
Pharmacology for NDA: 213312
Mechanism of ActionProtein Kinase Inhibitors
mTOR Inhibitors
Physiological EffectDecreased Immunologic Activity
Medical Subject Heading (MeSH) Categories for 213312
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Suppliers and Packaging for NDA: 213312
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FYARRO sirolimus POWDER;INTRAVENOUS 213312 NDA Aadi Bioscience 80803-153 80803-153-50 1 VIAL, SINGLE-USE in 1 CARTON (80803-153-50) / 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength100MG/VIAL
Approval Date:Nov 22, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 22, 2028
Regulatory Exclusivity Use:FOR THE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC MALIGNANT PERIVASCULAR EPITHELIOID CELL TUMOR (PECOMA)
Patent:10,206,887Patent Expiration:Apr 15, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:10,705,070Patent Expiration:Mar 5, 2036Product Flag?YSubstance Flag?Delist Request?

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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