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Last Updated: May 19, 2022

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 two patents protecting this drug.

This drug has forty-six patent family members in twenty-four 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:46
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 99
Clinical Trials: 2
Patent Applications: 1,110
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 Generic Entry Opportunity 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

US Patents and Regulatory Information for FOTIVDA

FOTIVDA is protected by two US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FOTIVDA is See Plans and Pricing.

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

Quinoline derivatives and quinazoline derivatives having azolyl group
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting FOTIVDA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Aveo Pharms FOTIVDA tivozanib hydrochloride CAPSULE;ORAL 212904-002 Mar 10, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Aveo Pharms FOTIVDA tivozanib hydrochloride CAPSULE;ORAL 212904-001 Mar 10, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Aveo Pharms FOTIVDA tivozanib hydrochloride CAPSULE;ORAL 212904-001 Mar 10, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aveo Pharms FOTIVDA tivozanib hydrochloride CAPSULE;ORAL 212904-002 Mar 10, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Germany 60226912 See Plans and Pricing
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) See Plans and Pricing
South Korea 100879669 See Plans and Pricing
Japan 2003012668 QUINOLIN DERIVATIVE HAVING AZOLYL GROUP AND QUINAZOLIN DERIVATIVE See Plans and Pricing
Australia 2002255284 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FOTIVDA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1382604 CR 2018 00007 Denmark See Plans and Pricing PRODUCT NAME: TIVOZANIB ELLER ET SALT ELLER SOLVAT DERAF, SAERLIGT HYDROCHLORIDMONOHYDRATET; REG. NO/DATE: EU/1/17/1215 20170829
1382604 122018000018 Germany See Plans and Pricing PRODUCT NAME: TIVOZANIB ODER EIN SALZ ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/17/1215 20170824
1382604 CA 2018 00007 Denmark See Plans and Pricing PRODUCT NAME: TIVOZANIB ELLER ET SLAT ELLER SOLVAT DERAF, SAERLIGT HYDROCHLORIDMONOHYDRATET; REG. NO/DATE: EU/1/17/1215 20170829
1382604 18C1006 France See Plans and Pricing 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 600 Finland See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
AstraZeneca
Mallinckrodt
McKesson
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.