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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FOTIVDA
*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 |
|---|---|
| Genentech, Inc. | Phase 1/Phase 2 |
| Aveo Oncology Pharmaceuticals | Phase 1/Phase 2 |
| University of Florida | Phase 1/Phase 2 |
Pharmacology for FOTIVDA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Tyrosine 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
| Aveo Pharms | FOTIVDA | tivozanib hydrochloride | CAPSULE;ORAL | 212904-002 | Mar 10, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Austria | 314361 | ⤷ Sign Up | |
| Norway | 2018005 | ⤷ Sign Up | |
| Japan | 3602513 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2004035572 | ⤷ Sign Up | |
| Norway | 326325 | ⤷ Sign Up | |
| European Patent Office | 1652847 | Dérivés de quinoline et quinazoline pour le traitement de tumeurs (Quinoline and quinazoline derivatives for the treatment of tumors) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FOTIVDA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 2018C/008 | Belgium | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | 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 | 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 |
| 1382604 | 600 | Finland | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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