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fotivda Drug Patent Profile

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When do Fotivda patents expire, and when can generic versions of Fotivda launch?

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

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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:	278
Drug Prices:	Drug price information for fotivda
What excipients (inactive ingredients) are in fotivda?	fotivda excipients list
DailyMed Link:	fotivda at DailyMed

Drug patent expirations by year for fotivda

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

Generic Entry Date for fotivda^: ⤷ Sign Up* 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
University of Florida	Phase 1/Phase 2
Genentech, Inc.	Phase 1/Phase 2
Aveo Oncology Pharmaceuticals	Phase 1/Phase 2

See all fotivda clinical trials

Pharmacology for fotivda

Drug Class	Kinase Inhibitor
Mechanism of Action	Tyrosine Kinase Inhibitors

US Patents and Regulatory Information for fotivda

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of fotivda is ⤷ Sign Up.

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

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULTS WITH MODERATE HEPATIC IMPAIRMENT AND RELAPSED OR REFRACTORY ADVANCED RENAL CELL CARCINOMA FOLLOWING TWO OR MORE PRIOR SYSTEMIC ANTI-CANCER THERAPIES WITH 1MG TIVOZANIB HCL ORALLY FOR 21 DAYS FOLLOWED BY NO DRUG FOR 7 DAYS

Quinoline derivatives and quinazoline derivatives having azolyl group
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING ADULTS WITH RELAPSED OR REFRACTORY ADVANCED RENAL CELL CARCINOMA FOLLOWING TWO OR MORE PRIOR SYSTEMIC THERAPIES BY INHIBITING THE ANGIOGENESIS OF BLOOD VESSELS WITH A VASCULAR ENDOTHELIAL GROWTH FACTOR INHIBITOR

N-{2-chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-n'-(5-methyl-3-isoxaz- olyl)urea salt in crystalline form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting fotivda

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-002	Mar 10, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-001	Mar 10, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-002	Mar 10, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-001	Mar 10, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-001	Mar 10, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	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

Expired US Patents for fotivda

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-001	Mar 10, 2021	⤷ Sign Up	⤷ Sign Up
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-002	Mar 10, 2021	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fotivda

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

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Country	Patent Number	Title	Estimated Expiration
Japan	3763414		⤷ Sign Up
Denmark	1559715		⤷ Sign Up
Japan	2003012668	QUINOLIN DERIVATIVE HAVING AZOLYL GROUP AND QUINAZOLIN DERIVATIVE	⤷ Sign Up
Norway	20034595		⤷ Sign Up
Mexico	2021005189	USO DE TIVOZANIB PARA TRATAR SUJETOS CON CANCER REFRACTARIO. (USE OF TIVOZANIB TO TREAT SUBJECTS WITH REFRACTORY CANCER.)	⤷ Sign Up
Brazil	PI0209216	derivados de quinolina e de quinazolina, composições farmacêuticas compreendendo os mesmos e seus usos	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for fotivda

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1382604	1890013-4	Sweden	⤷ Sign Up	PRODUCT NAME: TIVOZANIB OR A SALT OR SOLVATE THEREOF, IN PARTICULAR, THE HYDROCHLORIDE MONOHYDRATE; REG. NO/DATE: EU/1/17/1215 20170829
1382604	18C1006	France	⤷ Sign Up	PRODUCT NAME: TIVOZANIB OU UN DE SES SELS OU DE SES SOLVATES,EN PARTICULIER LE CHLORHYDRATE MONOHYDATE; REGISTRATION NO/DATE: EU/1/17/1215 20170829
1382604	122018000018	Germany	⤷ Sign Up	PRODUCT NAME: TIVOZANIB ODER EIN SALZ ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/17/1215 20170824
1382604	2018C/008	Belgium	⤷ Sign Up	PRODUCT NAME: TIVOZANIB, OF EEN ZOUT OF SOLVAAT HIERVAN, IN HET BIJZONDER HET HYDROCHLORIDEMONOHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1215 20170829
1382604	C201830013	Spain	⤷ Sign Up	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
1382604	132018000000121	Italy	⤷ Sign Up	PRODUCT NAME: TIVOZANIB O UN SUO SALE O SOLVATO, IN PARTICOLARE IL CLORIDRATO MONOIDRATO(FOTIVDA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1215, 20170829
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description