FOTIVDA Drug Patent Profile
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
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-four 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
Summary for FOTIVDA
| International Patents: | 54 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 116 |
| Clinical Trials: | 2 |
| Patent Applications: | 1,638 |
| Drug Prices: | Drug price information for FOTIVDA |
| What excipients (inactive ingredients) are in FOTIVDA? | FOTIVDA excipients list |
| DailyMed Link: | FOTIVDA at DailyMed |
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
| Sponsor | Phase |
|---|---|
| University of Florida | Phase 1/Phase 2 |
| Genentech, Inc. | Phase 1/Phase 2 |
| Aveo Oncology Pharmaceuticals | Phase 1/Phase 2 |
Pharmacology for FOTIVDA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Tyrosine Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for FOTIVDA
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 ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting FOTIVDA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Aveo Pharms | FOTIVDA | tivozanib hydrochloride | CAPSULE;ORAL | 212904-002 | Mar 10, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Aveo Pharms | FOTIVDA | tivozanib hydrochloride | CAPSULE;ORAL | 212904-001 | Mar 10, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for FOTIVDA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Aveo Pharms | FOTIVDA | tivozanib hydrochloride | CAPSULE;ORAL | 212904-001 | Mar 10, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Aveo Pharms | FOTIVDA | tivozanib hydrochloride | CAPSULE;ORAL | 212904-002 | Mar 10, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FOTIVDA
See the table below for patents covering FOTIVDA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Eurasian Patent Organization | 202191273 | ПРИМЕНЕНИЕ ТИВОЗАНИБА ДЛЯ ЛЕЧЕНИЯ СУБЪЕКТОВ С РЕФРАКТЕРНЫМ РАКОМ | ⤷ Try a Trial |
| Israel | 158459 | ⤷ Try a Trial | |
| Germany | 60316590 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FOTIVDA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1382604 | 122018000018 | Germany | ⤷ Try a Trial | PRODUCT NAME: TIVOZANIB ODER EIN SALZ ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/17/1215 20170824 |
| 1382604 | 2018C/008 | Belgium | ⤷ Try a Trial | PRODUCT NAME: TIVOZANIB, OF EEN ZOUT OF SOLVAAT HIERVAN, IN HET BIJZONDER HET HYDROCHLORIDEMONOHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1215 20170829 |
| 1382604 | 18C1006 | France | ⤷ Try a Trial | 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 |
| >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:
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2023 - 2024
NCE-1 Patent Challenge Dates 2023 - 2024
DrugChatter - AI-based answers to questions about drugs
RxJam - Trigger-based marketing for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
Follow DrugPatentWatch:
