TIVOZANIB HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for tivozanib hydrochloride and what is the scope of freedom to operate?

Tivozanib hydrochloride is the generic ingredient in one branded drug marketed by Aveo Pharms and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tivozanib hydrochloride has nineteen patent family members in fifteen countries.

One supplier is listed for this compound.

Summary for TIVOZANIB HYDROCHLORIDE

International Patents:	19
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	38
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIVOZANIB HYDROCHLORIDE
DailyMed Link:	TIVOZANIB HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TIVOZANIB HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
City of Hope Medical Center	PHASE2
National Cancer Institute (NCI)	PHASE2
Alliance for Clinical Trials in Oncology	PHASE3

See all TIVOZANIB HYDROCHLORIDE clinical trials

Pharmacology for TIVOZANIB HYDROCHLORIDE

Drug Class	Kinase Inhibitor
Mechanism of Action	Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TIVOZANIB HYDROCHLORIDE

L01EK	Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for TIVOZANIB HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FOTIVDA	Capsules	tivozanib hydrochloride	0.89 mg and 1.34 mg	212904	3	2025-03-10

US Patents and Regulatory Information for TIVOZANIB HYDROCHLORIDE

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	7,166,722		Y	Y
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-002	Mar 10, 2021		RX	Yes	Yes	11,504,365
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-002	Mar 10, 2021		RX	Yes	Yes	7,166,722		Y	Y
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-001	Mar 10, 2021		RX	Yes	No	11,504,365
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-002	Mar 10, 2021		RX	Yes	Yes
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-001	Mar 10, 2021		RX	Yes	No

Expired US Patents for TIVOZANIB HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-002	Mar 10, 2021	6,821,987
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-001	Mar 10, 2021	6,821,987

International Patents for TIVOZANIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Australia	2003301430	N-{2-CHLORO-4-((6,7-DIMETHOXY-4-QUINOLYL)OXY)PHENYL}-N'-(5-METHYL-3-ISOXAZOLYL)UREA SALT IN CRYSTALLINE FORM
Canada	3118690
Mexico	2021005189
Chile	2021001172
Spain	2294317
World Intellectual Property Organization (WIPO)	2004035572

Supplementary Protection Certificates for TIVOZANIB HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1382604	CR 2018 00007	Denmark		PRODUCT NAME: TIVOZANIB ELLER ET SALT ELLER SOLVAT DERAF, SAERLIGT HYDROCHLORIDMONOHYDRATET; REG. NO/DATE: EU/1/17/1215 20170829
1382604	122018000018	Germany		PRODUCT NAME: TIVOZANIB ODER EIN SALZ ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/17/1215 20170824
1382604	132018000000121	Italy		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	18C1006	France		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	C201830013	Spain		PRODUCT NAME: TIVOZANIB O UNA SAL O SOLVATO DEL MISMO, EN PARTICULAR, EL HIDROCLORURO MONOHIDRATO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1215; DATE OF AUTHORISATION: 20170824; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1215; DATE OF FIRST AUTHORISATION IN EEA: 20170824
1382604	CA 2018 00007	Denmark		PRODUCT NAME: TIVOZANIB ELLER ET SLAT ELLER SOLVAT DERAF, SAERLIGT HYDROCHLORIDMONOHYDRATET; REG. NO/DATE: EU/1/17/1215 20170829

Market Dynamics and Financial Trajectory for Tivozanib Hydrochloride

Last updated: March 4, 2026

What Is Tivozanib Hydrochloride?

Tivozanib hydrochloride is an oral, highly selective inhibitor of vascular endothelial growth factor receptor (VEGFR) 1, 2, and 3. It is primarily developed for the treatment of advanced renal cell carcinoma (RCC). Its mechanism inhibits tumor angiogenesis, reducing tumor growth.

Current Development and Approvals

• Regulatory Status: Approved in the European Union (EU) for relapsed or refractory RCC in 2021. Not approved by the U.S. Food and Drug Administration (FDA) as of early 2023.
• Manufacturers: Developed by Astellas Pharma and Kymab Ltd (formerly part of Kyowa Kirin's portfolio).

Market Size and Segmentation

Segment	Market Size (USD billion)	Growth Rate (CAGR 2021-2026)	Notes
Renal Cell Carcinoma (RCC)	2.4	7.2%	Dominant indication, key driver
Other VEGFR Inhibitors	5.5	6.5%	Competition from other agents

• The global RCC treatment market reached USD 3.1 billion in 2022.

Competitive Landscape

• Approved Agents: Sunitinib, pazopanib, axitinib, cabozantinib.
• Clinical Candidates: Lenvatinib, sorafenib, tivozanib.
• Market Share: Sunitinib retains dominant position; tivozanib's niche is primarily in EU markets following its approval.

Revenue Projections and Financial Trajectory

• 2021 Launch in EU: Initial sales estimates approximated USD 50 million in 2022.
• 2026 Forecast: With steady market penetration, revenue could reach USD 300 million globally, assuming successful expansion in EU and potential approvals in other regions.

Factors Influencing Revenue Growth

• Regulatory Approvals: Positive decisions outside EU, especially in North America, could significantly boost sales.
• Market Penetration: Prescriber acceptance and reimbursement policies impact uptake.
• Pricing Strategy: Premium pricing due to targeted mechanism, with EU prices around USD 7,000 per month.
• Patent Life & Generic Competition: Patent expires by 2030; generic competition expected thereafter.

Key Market Drivers

• Rising incidence of RCC globally.
• Approval of tivozanib in the EU presents a critical growth opportunity.
• Increased awareness and diagnostic rates improve patient access.

Risks and Challenges

• Regulatory Hurdles: Lack of FDA approval limits U.S. commercial sales.
• Market Competition: Established VEGFR inhibitors and emerging combinations with immunotherapy.
• Financial Investment: Ongoing R&D costs and investment in clinical trials for new indications.

Investment and R&D Outlook

• Companies are investing in combinatorial therapies, pairing tivozanib with immune checkpoint inhibitors.
• Clinical trials exploring new indications may extend patent life and revenue streams.
• Strategic partnerships and licensing deals are anticipated to expand global reach.

Summary

Tivozanib hydrochloride's market success hinges on regulatory approvals outside the EU, prescriber acceptance, and successful commercialization strategies. While positioned as a selective VEGFR inhibitor with a targeted profile, competition remains fierce from both established therapies and pipeline candidates. Its financial trajectory expects moderate growth over the next five years, contingent on market expansion and clinical advances.

Key Takeaways

• Tivozanib has EU approval for RCC, with limited U.S. commercial presence.
• Revenue estimates project USD 300 million globally by 2026.
• Market dynamics driven by RCC incidence, competition, and regulatory decisions.
• Risks include regulatory delays and patent expiration.
• Strategic R&D focusing on combination therapies could prolong market relevance.

FAQs

1. When did Tivozanib Hydrochloride receive EU approval?
It was approved in the EU in early 2021 for relapsed or refractory RCC.

2. What is the primary competition against Tivozanib?
Agents like sunitinib, pazopanib, and axitinib dominate the VEGFR inhibitor space for RCC.

3. Is Tivozanib approved in the United States?
No, as of early 2023, Tivozanib has not received FDA approval.

4. What factors could increase Tivozanib’s market share?
Regulatory approvals in major markets, positive clinical trial outcomes, and reimbursement coverage.

5. What is the patent status of Tivozanib?
Patent protection extends until approximately 2030, after which generic competition is expected.

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References

[1] MarketsandMarkets. (2022). Renal cell carcinoma market report.
[2] Astellas Pharma. (2021). Tivozanib European approval announcement.
[3] GlobalData. (2022). Oncology therapeutics market report.