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Last Updated: July 16, 2024

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FOTIVDA Drug Patent Profile


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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

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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
Drug Prices for FOTIVDA

See drug prices for FOTIVDA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FOTIVDA
Generic Entry Date for FOTIVDA*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
NDA:
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

SponsorPhase
Aveo Oncology PharmaceuticalsPhase 1/Phase 2
University of FloridaPhase 1/Phase 2
Genentech, Inc.Phase 1/Phase 2

See all FOTIVDA clinical trials

Pharmacology for FOTIVDA
Drug ClassKinase Inhibitor
Mechanism of ActionTyrosine 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

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

International Patents for FOTIVDA

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

Country Patent Number Title Estimated Expiration
Russian Federation 2283841 АЗОЛИЛЬНЫЕ ПРОИЗВОДНЫЕ ХИНОЛИНА И ХИНАЗОЛИНА, СОДЕРЖАЩАЯ ИХ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ИХ ПРИМЕНЕНИЕ И СПОСОБ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ (AZOLYL QUINOLINE AND QUINAZOLINE DERIVATIVES, PHARMASEUTICAL COMPOSITION CONTAINING THE SAME, USES THEREOF AND METHOD FOR TREATMENT OF DISEASES) ⤷  Sign Up
Brazil 112021008606 uso de tivozanibe para tratar indivíduos com câncer refratário ⤷  Sign Up
Hong Kong 1070649 ⤷  Sign Up
Spain 2256466 ⤷  Sign Up
Denmark 1559715 ⤷  Sign Up
Poland 209822 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FOTIVDA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1382604 CA 2018 00007 Denmark ⤷  Sign Up PRODUCT NAME: TIVOZANIB ELLER ET SLAT ELLER SOLVAT DERAF, SAERLIGT HYDROCHLORIDMONOHYDRATET; REG. NO/DATE: EU/1/17/1215 20170829
1559715 2018/009 Ireland ⤷  Sign Up PRODUCT NAME: TIVOZANIB OR A SALT OR SOLVATE THEREOF, IN PARTICULAR, THE HYDROCHLORIDE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1215 20170829
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 122018000018 Germany ⤷  Sign Up PRODUCT NAME: TIVOZANIB ODER EIN SALZ ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/17/1215 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
1382604 300927 Netherlands ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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