FOTIVDA Drug Patent Profile

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 and one Paragraph IV challenge.

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 was eligible for patent challenges on March 10, 2025.

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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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
Drug Prices:	Drug price information for FOTIVDA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FOTIVDA
What excipients (inactive ingredients) are in FOTIVDA?	FOTIVDA excipients list
DailyMed Link:	FOTIVDA at DailyMed

See drug prices for FOTIVDA

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

212904

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
Aveo Oncology Pharmaceuticals	Phase 1/Phase 2
University of Florida	Phase 1/Phase 2
Genentech, Inc.	Phase 1/Phase 2

See all FOTIVDA clinical trials

Pharmacology for FOTIVDA

Drug Class	Kinase Inhibitor
Mechanism of Action	Tyrosine Kinase Inhibitors

Paragraph IV (Patent) Challenges for FOTIVDA

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 FOTIVDA

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

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.

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			Y	Y
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-002	Mar 10, 2021		RX	Yes	Yes			Y	Y
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-001	Mar 10, 2021		RX	Yes	No
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
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-001	Mar 10, 2021		RX	Yes	No			Y	Y
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-002	Mar 10, 2021		RX	Yes	Yes

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
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-002	Mar 10, 2021

International Patents for FOTIVDA

See the table below for patents covering FOTIVDA around the world.

Country	Patent Number	Title	Estimated Expiration
China	1273466
Canada	2445333	DERIVES DE QUINOLINE ET DE QUINAZOLINE AYANT UN GROUPE AZOLYLE (QUINOLINE DERIVATIVES AND QUINAZOLINE DERIVATIVES HAVING AZOLYL GROUP)
Japan	3602513
European Patent Office	1652847	Dérivés de quinoline et quinazoline pour le traitement de tumeurs (Quinoline and quinazoline derivatives for the treatment of tumors)
Israel	282869
Mexico	PA03009662	DERIVADOS DE QUINOLINA Y DERIVADOS DE QUINAZOLINA QUE TIENEN GRUPOS AZOLILO. (QUINOLINE DERIVATIVE HAVING AZOLYL GROUP AND QUINAZOLINE DERIVATIVE.)
Israel	158459

Supplementary Protection Certificates for FOTIVDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	600	Finland
1382604	2018C/008	Belgium		PRODUCT NAME: TIVOZANIB, OF EEN ZOUT OF SOLVAAT HIERVAN, IN HET BIJZONDER HET HYDROCHLORIDEMONOHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1215 20170829
1382604	300927	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
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
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	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 the Pharmaceutical Drug: FOTIVDA

Last updated: July 27, 2025

Introduction

FOTIVDA (tivozanib), developed by Aveo Oncology, has established itself within the oncology landscape as a selective inhibitor targeting vascular endothelial growth factor receptors (VEGFR-1, VEGFR-2, and VEGFR-3). It primarily addresses advanced renal cell carcinoma (RCC), a cancer subtype with persistent unmet needs despite existing therapies. This analysis examines the current market environment, competitive positioning, regulatory landscape, and the financial trajectory of FOTIVDA, offering strategic insights for stakeholders.

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Market Landscape and Demand Drivers

The global renal cell carcinoma market is projected to grow at a CAGR of approximately 5-7% through 2030, driven by increasing incidence rates, early diagnosis, and expanding therapeutic options (source: MarketsandMarkets). The rising prevalence of RCC—estimated at over 400,000 new cases annually worldwide—creates sustained demand for effective targeted therapies like FOTIVDA (globally, RCC comprises roughly 2-3% of all adult cancers).

FOTIVDA's role in the landscape is as a targeted anti-angiogenic agent, specifically indicated for advanced or metastatic RCC. It offers distinct advantages owing to its selective VEGFR inhibition, which potentially minimizes off-target toxicities. The drug is positioned as a monotherapy option following previous treatments, including cytokines and other tyrosine kinase inhibitors (TKIs).

The therapeutic pathway for RCC has evolved, with immune checkpoint inhibitors (e.g., nivolumab, pembrolizumab) and combination regimens gaining prominence. Despite this, FOTIVDA’s unique mechanism offers niche positioning, especially for patients intolerant to immunotherapy or those with specific molecular profiles.

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Regulatory and Clinical Milestones

FOTIVDA received FDA approval in August 2021 for adult patients with relapsed or refractory RCC following prior systemic therapy, based on pivotal phase 3 trial results demonstrating progression-free survival (PFS) benefits (notably, a median PFS of 5.6 months compared to 1.8 months for everolimus). It also received regulatory approvals in the European Union and Japan, enhancing its geographic footprint.

Continued clinical development includes trials in combination with immune therapies, seeking to broaden therapeutic indications and improve efficacy endpoints such as overall survival (OS). These developments could fortify FOTIVDA’s market position if positive outcomes materialize.

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Competitive Landscape and Market Share

FOTIVDA operates within a highly competitive market. First-line treatments for RCC include immunotherapy-based combinations such as nivolumab plus ipilimumab, and TKIs like pazopanib and sunitinib. These agents often set the benchmark for efficacy and tolerability (source: NCCN Guidelines).

In the second-line setting, drugs like cabozantinib, axitinib, and everolimus dominate. FOTIVDA’s advantage lies in its selective VEGFR inhibition, which might translate into a differentiated safety profile, potentially appealing to specific patient subsets.

Market penetration is contingent on multiple factors:

• Physician Adoption: Convincing clinicians of FOTIVDA's efficacy, safety, and ease of use.
• Reimbursement and Pricing: Negotiations with payers influence prescribing patterns.
• Combination Strategies: Integrating FOTIVDA with immune checkpoint inhibitors could unlock greater demand, especially if clinical data demonstrate superior outcomes.

Current market share remains modest but is expected to expand with ongoing clinical success and increased awareness.

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Pricing Strategies and Commercial Performance

FOTIVDA’s pricing aligns with premium targeted therapies, with estimated wholesale acquisition costs (WAC) around $15,000–$16,000 per month (sources: FDA label and market reports). Reimbursement coverage from Medicare, Medicaid, and private insurers is pivotal for access, influencing revenue realization.

Early commercial data indicate a steady uptake in the US and select European markets. Market access negotiations and formulary placements are ongoing, with emphasis on demonstrating cost-effectiveness in the context of evolving RCC treatment algorithms.

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Financial Trajectory and Revenue Projections

FOTIVDA's financial outlook hinges on several key factors:

• Market Penetration Rate: Assumed gradual increase as clinical validation and awareness grow.
• Geographic Expansion: Additional approvals in Asia and other territories can substantially augment revenue streams.
• Clinical Pipeline: New indications or combination regimens, pending trial success, might significantly boost sales volume.

Based on current data, Aveo Oncology projects revenues in the low hundreds of millions within the next three to five years. For instance, if FOTIVDA captures 10-15% of the second-line RCC market in the US and Europe—estimated at approximately $1 billion—we can anticipate revenues of $100–$150 million initially, with potential for growth.

Cost of goods sold (COGS), marketing, and R&D obligations influence net margins. With optimized commercialization strategies, EBITDA margins could improve over time, supporting reinvestment into pipeline development or further trials.

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Regulatory and Market Risks

Key risks include:

• Market Competition: Entry of new agents and combination therapies could erode FOTIVDA’s market share.
• Clinical Outcomes: Failure to demonstrate superior efficacy or safety in ongoing trials might limit market adoption.
• Pricing Pressures: Payer pushback on drug pricing could impact revenue margins.
• Regulatory Delays: Longer approval timelines or additional data requests can hinder market expansion.

However, FOTIVDA’s differentiated profile supports its positioning, especially if ongoing studies reveal compelling benefits.

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Strategic Opportunities for Growth

To enhance FOTIVDA’s financial trajectory, Aveo Oncology should pursue:

• Combination Therapies: Accelerate trials combining FOTIVDA with immune checkpoint inhibitors.
• Geographic Expansion: Target emerging markets with high RCC incidence and favorable regulatory environments.
• Real-World Evidence Generation: Collect post-market data to demonstrate efficacy, safety, and cost-effectiveness to payers.
• Market Education: Increase outreach targeting oncologists and healthcare providers to bolster adoption.

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Key Takeaways

1. FOTIVDA’s niche positioning in RCC provides growth potential amid intense competition. Its selective VEGFR inhibition offers a favorable safety profile, appealing to specific patient populations.

2. Regulatory milestones and ongoing clinical trials are pivotal to expanding indications and improving its market share. Positive results could trigger commercialization in combination therapies, unlocking higher revenue.

3. Pricing strategies and reimbursement negotiations significantly influence commercial success. Currently priced at premium levels, FOTIVDA’s revenue depends on payer acceptance and formulary inclusion.

4. Market dynamics are shaped by evolving treatment standards, notably the rise of immunotherapy combinations, necessitating strategic adaptation. FOTIVDA’s future growth hinges on effective integration with emerging therapeutic landscapes.

5. Financial projections indicate steady revenue growth over the next 3-5 years, contingent upon successful clinical and regulatory progress. Scalability through geographic expansion and combination regimens remains critical.

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FAQs

1. What distinguishes FOTIVDA from other RCC therapies?
FOTIVDA’s selective VEGFR inhibition aims to provide targeted anti-angiogenic effects with potentially fewer off-target toxicities, offering a treatment alternative post-failure of initial therapies and possibly a better tolerability profile.

2. How does FOTIVDA compare in efficacy to current first-line RCC treatments?
FOTIVDA is approved for relapsed or refractory RCC, not as a first-line agent. While direct head-to-head data are limited, its clinical trials demonstrate significant PFS benefits. Future studies combining it with immunotherapies could alter its positioning.

3. What are the primary challenges facing FOTIVDA’s commercial growth?
The main challenges include stiff competition from immunotherapy-based regimens, payer reimbursement hurdles, and the evolving RCC treatment landscape favoring combination therapies.

4. How might ongoing clinical trials influence FOTIVDA’s market trajectory?
Successful trials of FOTIVDA combined with checkpoint inhibitors could significantly broaden its indications, increase demand, and elevate its market share.

5. What strategic actions can Aveo Oncology take to maximize FOTIVDA’s commercial potential?
The company should focus on accelerating clinical development, expanding geographic access, optimizing pricing strategies, and investing in educational initiatives to increase clinician awareness.

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References

[1] MarketsandMarkets, "Renal Cell Carcinoma Market," 2022.
[2] FDA. FOTIVDA (tivozanib) prescribing information, 2021.
[3] NCCN Guidelines, Kidney Cancer (2023).
[4] Aveo Oncology. FOTIVDA clinical development pipeline updates, 2023.
[5] Industry reports, "Global RCC Treatment Market," 2022.