Tivozanib hydrochloride - Generic Drug Details

What are the generic drug sources for tivozanib hydrochloride and what is the scope of patent protection?

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

Tivozanib hydrochloride has fifty-five patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for tivozanib hydrochloride

International Patents:	55
US Patents:	3
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for tivozanib hydrochloride

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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 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	212904-002	Mar 10, 2021		RX	Yes	Yes
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-001	Mar 10, 2021		RX	Yes	No	6,821,987		Y	Y
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	7,166,722		Y	Y
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-002	Mar 10, 2021		RX	Yes	Yes	6,821,987		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	212904-001	Mar 10, 2021		RX	Yes	No	11,504,365

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	2002255284
Austria	374199
Brazil	0209216
Germany	60226912
Austria	314361
Poland	367105
European Patent Office	1382604	DERIVES DE QUINOLINE AYANT UN GROUPE AZOLYLE ET DERIVES DE QUINAZOLINE (QUINOLINE DERIVATIVE HAVING AZOLYL GROUP AND QUINAZOLINE DERIVATIVE)

Supplementary Protection Certificates for tivozanib hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1559715	2018/009	Ireland		PRODUCT NAME: TIVOZANIB OR A SALT OR SOLVATE THEREOF, IN PARTICULAR, THE HYDROCHLORIDE MONOHYDRATE; 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	300927	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
1382604	600	Finland
1382604	1890013-4	Sweden		PRODUCT NAME: TIVOZANIB OR A SALT OR SOLVATE THEREOF, IN PARTICULAR, THE HYDROCHLORIDE MONOHYDRATE; REG. NO/DATE: EU/1/17/1215 20170829
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

Market Dynamics and Financial Trajectory for Tivozanib Hydrochloride

Last updated: July 28, 2025

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Introduction

Tivozanib hydrochloride, a potent and selective oral vascular endothelial growth factor receptor (VEGFR) inhibitor, has garnered significant attention in the oncology therapeutics landscape. Originally developed for the treatment of advanced renal cell carcinoma (RCC), it represents a targeted approach to tumor angiogenesis, pivotal in cancer progression. As the global oncology market evolves, understanding the market dynamics and financial trajectory of Tivozanib hydrochloride becomes critical for stakeholders deploying strategic investments, licensing agreements, or R&D focus.

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Pharmacological Profile and Clinical Development

Tivozanib operates by selectively inhibiting VEGFR-1, -2, and -3, crucial mediators in tumor angiogenesis. Its pharmacokinetic profile offers advantages, including high bioavailability and favorable safety profile compared to less selective VEGFR inhibitors. Pharmacologically, Tivozanib's potency and selectivity position it as a candidate for monotherapy or combination regimens in RCC and other VEGF-driven malignancies.

The drug's clinical trajectory has primarily involved Phase III trials for relapsed or refractory RCC, leading to regulatory submissions. A notable milestone includes its approval in the European Union in 2021, under the brand name Fotivda, signifying formal recognition of its efficacy and safety profile.

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Market Dynamics

1. Competitive Landscape

The VEGFR inhibitor market is characterized by established players like sunitinib, pazopanib, and cabozantinib, offering broad-spectrum antiangiogenic effects. Tivozanib differentiates through its selectivity, which purportedly results in lower adverse events and improved patient tolerability. Nonetheless, competition remains fierce, as existing therapies possess extensive clinical validation and market penetration.

Emerging competitors, including other selective VEGFR inhibitors or combination therapies involving immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab), threaten to erode Tivozanib's market share.

2. Regulatory and Approval Milestones

Regulatory approvals significantly influence market viability. Tivozanib's approval in Europe catalyzed commercialization efforts; however, delayed or unsuccessful submissions in other markets, notably the U.S., due to FDA concerns over clinical data, have hampered its global market penetration. Regulatory agencies demand robust evidence of superiority or added value over existing therapies, impacting its commercial trajectory.

3. Market Penetration and Adoption

Adoption in clinical practice depends on demonstrated efficacy, safety, cost-effectiveness, and physician familiarity. Tivozanib’s favorable safety profile offers a potential edge, but its uptake remains limited outside Europe. The drug's integration requires active education, evidence generation, and reimbursement support.

4. Pricing and Reimbursement

Pricing strategies are tailored to competitive positioning; Tivozanib's pricing must balance profitability with payer acceptance. Reimbursement landscape varies globally, with Europe showing more favorable pathways, whereas in the U.S., payer negotiations have posed challenges, impacting revenue streams.

5. Market Size and Growth Potential

The RCC market alone is estimated to reach USD 7-8 billion by 2025, with targeted therapies commanding premium pricing. Tivozanib’s market opportunity hinges on line-of-therapy positioning, combination indications, and expansion into other VEGFR-driven cancers. The rising prevalence of RCC worldwide bolsters the therapeutic landscape’s size and growth prospects.

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Financial Trajectory

1. Revenue Projections

Following its European approval, initial revenues are expected to be modest, constrained by limited geographic availability and competitive pressures. Over 5-7 years, revenues could increase substantially with broader approvals, increased physician adoption, and expansion into combination treatments. Revenue estimates vary, with potential to reach hundreds of millions USD annually in a high-adoption scenario.

2. R&D and Commercial Investment

Significant investments are directed towards Phase IV studies, post-marketing surveillance, and trials exploring combination regimens. These investments, while increasing near-term expenditures, aim to support market expansion and solidify clinical efficacy data.

3. Licensing and Strategic Alliances

Collaborations with biotech firms, oncology research consortia, and pharmaceutical companies can accelerate market penetration. Licensing agreements can offset R&D costs and provide alternative revenue streams, impacting the financial trajectory positively.

4. Competitive Pricing and Market Penetration Strategies

Pricing strategies, reimbursement negotiations, and physician education directly influence revenue realization. Entry into new markets or indications could serve as substantial revenue catalysts, provided approval pathways are navigated efficiently.

5. Patent and Intellectual Property Considerations

Patent protection ensures market exclusivity for a defined period, crucial for recouping R&D investments. Expiry timelines and potential patent litigations could impact long-term revenues, emphasizing the importance of strategic patent management.

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Regulatory and Market Challenges

Regulatory hurdles, such as the FDA rejection in 2020 due to insufficient evidence of superiority, underscore the importance of robust clinical data. Market dynamics will continue to be shaped by evolving guidelines, approval timelines, and competitor strategies. Additionally, healthcare systems’ shift towards combination therapies might dilute monotherapy sales unless Tivozanib demonstrates additive or synergistic benefits.

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Future Outlook

The outlook hinges on successful clinical trial outcomes, regulatory approvals across major regions, and strategic commercial activities. Innovations such as biomarker-driven patient selection or optimized combination regimens with immunotherapies could unlock new market segments. The potential to extend indications beyond RCC to other neovascularized tumors offers additional revenue pathways.

Given the competitive landscape, Tivozanib’s financial trajectory will depend on its clinical positioning, market access strategies, and ability to innovate within a rapidly evolving oncology therapeutics space.

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Key Takeaways

• Market Entry and Differentiation: Tivozanib’s selectivity offers a safety advantage but faces stiff competition from broader-spectrum VEGFR inhibitors. Differentiation through efficacy, safety, and combination potential is vital.
• Regulatory Strategy: Navigating regulatory pathways remains critical. Successful approval in key markets like the U.S. could catalyze accelerated revenues, whereas setbacks may delay commercialization.
• Revenue Growth Factors: Broader approvals, clinician adoption, pricing strategies, and successful indications expansion are crucial drivers.
• Investment Focus: Continued R&D investments into combination therapies and biomarker-enriched trials could enhance long-term market potential.
• Competitive Dynamics: The active landscape necessitates strategic licensing, partnerships, and innovation to maintain or grow market share.

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FAQs

1. What are the major competitors of Tivozanib in the RCC market?
Major competitors include sunitinib, pazopanib, cabozantinib, and axitinib—all broad-spectrum VEGFR inhibitors with entrenched market positions and extensive clinical data supporting their use.

2. What challenges has Tivozanib faced in gaining regulatory approval?
The primary challenge was the FDA’s rejection in 2020, citing insufficient evidence of superiority over existing treatments, necessitating further trials to demonstrate added benefit.

3. How does Tivozanib’s safety profile influence its market potential?
Its favorable safety profile, characterized by fewer severe adverse events, could incentivize adoption, especially among patients intolerant to other VEGFR inhibitors, providing a competitive edge if clinical efficacy is maintained.

4. What markets offer the greatest growth potential for Tivozanib?
Europe provides an established regulatory environment, with significant market penetration potential. The U.S. remains a high-priority target pending regulatory approval; emerging markets with increasing RCC prevalence also present growth opportunities.

5. What strategic initiatives could enhance Tivozanib’s financial outlook?
Securing broad regulatory approvals, expanding indications through clinical trials, fostering partnerships, implementing value-based pricing, and investing in physician education are vital strategies to optimize its financial trajectory.

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References

1. [1] European Medicines Agency (EMA). Fotivda (tivozanib) European Public Assessment Report.
2. [2] U.S. Food and Drug Administration (FDA). Tivozanib New Drug Application rejection.
3. [3] Global Data (2022). RCC Therapeutics Market Report.
4. [4] ClinicalTrials.gov. Tivozanib clinical trial portfolio.
5. [5] IQVIA. Oncology Market Insights Report (2022).