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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 212904


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NDA 212904 describes FOTIVDA, which is a drug marketed by Aveo Pharms and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the FOTIVDA profile page.

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.
Summary for 212904
Tradename:FOTIVDA
Applicant:Aveo Pharms
Ingredient:tivozanib hydrochloride
Patents:3
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212904
Generic Entry Date for 212904*:
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.

Pharmacology for NDA: 212904
Mechanism of ActionTyrosine Kinase Inhibitors
Suppliers and Packaging for NDA: 212904
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOTIVDA tivozanib hydrochloride CAPSULE;ORAL 212904 NDA AVEO Pharmaceuticals, Inc. 45629-089 45629-089-01 24 BOTTLE, PLASTIC in 1 CARTON (45629-089-01) / 21 CAPSULE in 1 BOTTLE, PLASTIC
FOTIVDA tivozanib hydrochloride CAPSULE;ORAL 212904 NDA AVEO Pharmaceuticals, Inc. 45629-134 45629-134-01 24 BOTTLE, PLASTIC in 1 CARTON (45629-134-01) / 21 CAPSULE in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.89MG BASE
Approval Date:Mar 10, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 10, 2026
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Try a TrialPatent Expiration:Nov 5, 2039Product Flag?Substance Flag?Delist Request?
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
Patent:⤷  Try a TrialPatent Expiration:Apr 26, 2024Product Flag?YSubstance Flag?YDelist Request?
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

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