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	212904-001	Mar 10, 2021		RX	Yes	No
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			Y	Y
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			Y	Y

International Patents for tivozanib hydrochloride

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

Supplementary Protection Certificates for tivozanib hydrochloride

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