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FOTIVDA Drug Patent Profile

When do Fotivda patents expire, and what generic alternatives are available?

Fotivda is a drug marketed by Aveo Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-five patent family members in twenty-six countries.

The generic ingredient in FOTIVDA is tivozanib hydrochloride. One supplier is listed for this compound. Additional details are available on the tivozanib hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Fotivda

Fotivda will be eligible for patent challenges on March 10, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 10, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FOTIVDA

International Patents:	55
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	2
Patent Applications:	388
Drug Prices:	Drug price information for FOTIVDA
What excipients (inactive ingredients) are in FOTIVDA?	FOTIVDA excipients list
DailyMed Link:	FOTIVDA at DailyMed

See drug prices for FOTIVDA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FOTIVDA

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

212904

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FOTIVDA

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

Sponsor	Phase
Genentech, Inc.	Phase 1/Phase 2
Aveo Oncology Pharmaceuticals	Phase 1/Phase 2
University of Florida	Phase 1/Phase 2

See all FOTIVDA clinical trials

Pharmacology for FOTIVDA

Drug Class	Kinase Inhibitor
Mechanism of Action	Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FOTIVDA

L01EK	Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for FOTIVDA

FOTIVDA is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting FOTIVDA

FDA Regulatory Exclusivity protecting FOTIVDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-001	Mar 10, 2021		RX	Yes	No			Y	Y
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-002	Mar 10, 2021		RX	Yes	Yes			Y	Y
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-001	Mar 10, 2021		RX	Yes	No
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-002	Mar 10, 2021		RX	Yes	Yes
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-001	Mar 10, 2021		RX	Yes	No
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-001	Mar 10, 2021		RX	Yes	No			Y	Y

International Patents for FOTIVDA

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1070649
Japan	3763414
Denmark	1382604
South Korea	100879669
Brazil	0209216
Taiwan	I324154

Supplementary Protection Certificates for FOTIVDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1559715	2018/009	Ireland		PRODUCT NAME: TIVOZANIB OR A SALT OR SOLVATE THEREOF, IN PARTICULAR, THE HYDROCHLORIDE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1215 20170829
1382604	CA 2018 00007	Denmark		PRODUCT NAME: TIVOZANIB ELLER ET SLAT ELLER SOLVAT DERAF, SAERLIGT HYDROCHLORIDMONOHYDRATET; REG. NO/DATE: EU/1/17/1215 20170829
1382604	2018C/008	Belgium		PRODUCT NAME: TIVOZANIB, OF EEN ZOUT OF SOLVAAT HIERVAN, IN HET BIJZONDER HET HYDROCHLORIDEMONOHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1215 20170829
1382604	600	Finland
1382604	122018000018	Germany		PRODUCT NAME: TIVOZANIB ODER EIN SALZ ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/17/1215 20170824
1382604	C201830013	Spain		PRODUCT NAME: TIVOZANIB O UNA SAL O SOLVATO DEL MISMO, EN PARTICULAR, EL HIDROCLORURO MONOHIDRATO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1215; DATE OF AUTHORISATION: 20170824; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1215; DATE OF FIRST AUTHORISATION IN EEA: 20170824