Tivozanib hydrochloride - Generic Drug Details

What are the generic drug sources for tivozanib hydrochloride and what is the scope of patent protection?

Tivozanib hydrochloride is the generic ingredient in one branded drug marketed by Aveo Pharms and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tivozanib hydrochloride has fifty-five patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for tivozanib hydrochloride

International Patents:	55
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	35
Patent Applications:	750
DailyMed Link:	tivozanib hydrochloride at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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 tivozanib hydrochloride

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

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

See all tivozanib hydrochloride clinical trials

Pharmacology for tivozanib hydrochloride

Drug Class	Kinase Inhibitor
Mechanism of Action	Tyrosine Kinase Inhibitors

US Patents and Regulatory Information for tivozanib hydrochloride

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	212904-002	Mar 10, 2021		RX	Yes	Yes
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

Expired US Patents for tivozanib hydrochloride

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

International Patents for tivozanib hydrochloride

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1559715	SEL DE N- {2-CHLORO-4-[(6,7-DIMETHOXY-4-QUINOLYL)OXY]PHENYL} -N'-(5-METHYL-3-ISOXAZOLYL)UREE SOUS FORME CRISTALLINE (N-{2-CHLORO-4-[(6,7-DIMETHOXY-4-QUINOLYL)OXY]PHENYL}-N'-(5-METHYL-3-ISOXAZOLYL)UREA SALT IN CRYSTALLINE FORM)
South Africa	200307861	Quinoline derivative having azolyl group and quinazoline derivative.
China	1273466

Supplementary Protection Certificates for tivozanib hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1382604	132018000000121	Italy		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
1382604	18C1006	France		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	1890013-4	Sweden		PRODUCT NAME: TIVOZANIB OR A SALT OR SOLVATE THEREOF, IN PARTICULAR, THE HYDROCHLORIDE MONOHYDRATE; REG. NO/DATE: EU/1/17/1215 20170829