FYARRO Drug Patent Profile

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 five patents protecting this drug.

This drug has one hundred and forty-nine 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 8^th, 2014.

Summary for FYARRO

International Patents:	149
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	1
Patent Applications:	3,445
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FYARRO
What excipients (inactive ingredients) are in FYARRO?	FYARRO excipients list
DailyMed Link:	FYARRO at DailyMed

See drug prices for FYARRO

Recent Clinical Trials for FYARRO

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

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

See all FYARRO clinical trials

Pharmacology for FYARRO

Drug Class	Kinase Inhibitor mTOR Inhibitor Immunosuppressant
Mechanism of Action	Protein Kinase Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

Anatomical Therapeutic Chemical (ATC) Classes for FYARRO

L01EG	Mammalian target of rapamycin (mTOR) kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AH	Mammalian target of rapamycin (mTOR) kinase inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for FYARRO

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

Patents protecting FYARRO

FDA Regulatory Exclusivity protecting FYARRO

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
Aadi	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes
Aadi	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes			Y

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

International Patents for FYARRO

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

Country	Patent Number	Title	Estimated Expiration
Spain	2764100
Slovenia	2419732
Russian Federation	2483714	НАНОЧАСТИЦА, СОДЕРЖАЩАЯ РАПАМИЦИН И АЛЬБУМИН, В КАЧЕСТВЕ ПРОТИВОРАКОВОГО АГЕНТА (NANOPARTICLE, CONTAINING RAPAMYCIN AND ALBUMIN AS ANTI-CANCER AGENT)

Supplementary Protection Certificates for FYARRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0648494	24/2001	Austria		PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: LI 5524301 20000926
0648494	SPC/GB01/037	United Kingdom		PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313
0648494	C300055	Netherlands		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