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 two patents protecting this drug and one Paragraph IV challenge.

This drug has nineteen patent family members in fifteen 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 November 16, 2028. 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:	19
US Patents:	2
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

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 two US patents and one FDA Regulatory Exclusivity.

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
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			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	212904-002	Mar 10, 2021		RX	Yes	Yes			Y	Y

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
Austria	396988
Chile	2021001172
Japan	2010077131	AZOLYL GROUP-BEARING QUINOLINE DERIVATIVE AND QUINAZOLINE DERIVATIVE
World Intellectual Property Organization (WIPO)	2004035572
Belgium	2018C008
Brazil	112021008606
Poland	209822

Supplementary Protection Certificates for FOTIVDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1382604	122018000018	Germany		PRODUCT NAME: TIVOZANIB ODER EIN SALZ ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/17/1215 20170824
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	300927	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
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	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	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	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

Market Dynamics and Financial Trajectory for FOTIVDA

Last updated: February 25, 2026

What is FOTIVDA’s Current Market Position?

FOTIVDA (tivozanib) is an oral tyrosine kinase inhibitor developed by AVEO Pharmaceuticals. It targets vascular endothelial growth factor receptors (VEGFRs) 1, 2, and 3. Approved in the U.S. in March 2021 for advanced renal cell carcinoma (RCC) after two prior systemic therapies, its market position relies heavily on its clinical profile and regulatory approvals.

What Are the Key Market Drivers?

Clinical Data and Regulatory Status

• Approval: FDA approved FOTIVDA for adult patients with relapsed or refractory advanced RCC.
• Efficacy: Phase III trial (TIVO-3) showed improved median progression-free survival (PFS) of 5.6 months versus 3.9 months for the sorafenib comparator.[1]
• Side Effect Profile: FOTIVDA exhibits a manageable safety profile, with fewer hypertension and hand-foot syndrome cases compared to competitors.

Competitive Landscape

• FOTIVDA faces competition from other VEGFR inhibitors such as sunitinib, axitinib, and cabozantinib.
• Market dominance by pembrolizumab + axitinib combination therapy with regulatory approval in first-line settings reduces second-line growth prospects.

Market Penetration Strategies

• Focus on relapsed RCC patients who have failed prior therapies.
• Collaborations with key oncology centers and patient advocacy groups.

Market Challenges

• Limited approved indications restrict revenue streams.
• Competition from combination immunotherapy regimens, which are becoming standard initial treatments.

How Does FOTIVDA’s Financial Trajectory Look?

Revenue Generation

• Initial Sales: Expected moderate initial uptake due to niche second-line indication.
• Sales Assumptions: Based on analyst estimates, FOTIVDA’s 2022 sales approached $10 million, with projected annual growth rates of 30-50% over the next five years following increased awareness and expanded indications.[2]

Cost Structure

• Development costs were approximately $250 million (including clinical trials and regulatory expenses).
• Manufacturing costs are relatively low, as Tivozanib is an oral small molecule drug.

Profitability Outlook

• Current gross margins estimated at 70% due to high drug price points and low production costs.
• Break-even expected within 3-4 years, contingent on market penetration and competitive pressures.

Revenue Risks

• Market saturation due to existing therapies.
• Entry of biosimilars or new competitors reducing price premiums.
• Potential approval for additional indications (e.g., other solid tumors) could expand revenue.

Expansion Opportunities

• Pending Phase II trial results in other cancers, such as soft tissue sarcoma.
• Collaborations with pharmaceutical companies to develop combination regimens.

What Are the Key Market Trends Influencing FOTIVDA?

• Move toward combination therapies: Checkpoint inhibitors with VEGFR inhibitors are preferred first-line treatments.
• Growing RCC patient population: Estimated at more than 400,000 worldwide, with an annual incidence rate of 4.5 per 100,000 globally.[3]
• Regulatory shifts: Accelerated approval pathways and off-label use influence sales patterns.

How Do Market and Financial Factors Differ by Region?

Region	Market Size (USD)	Regulatory Environment	Competitive Intensity	FOTIVDA Position
North America	$1.2 billion	Well-established, rapid approval processes	High	Recently launched, niche player
Europe	$700 million	Moderate to strict, evolving guidelines	Moderate	Market entry in 2022, cautious uptake
Asia-Pacific	$600 million	Varies by country, slower approvals	High	Limited presence, growing interest

What Is the Outlook for FOTIVDA’s Long-term Success?

• Dominant in a specific niche (second-line RCC), but market expansion depends on approval for new indications.
• Market growth hinges on the success of Phase II trials in other cancer types and partnerships.
• Competitive pressures from emerging therapies may limit long-term pricing power and market share.

Key Takeaways

• FOTIVDA is positioned as a second-line treatment for RCC with moderate initial sales. Growth prospects depend heavily on clinical expansion and increasing adoption.
• Competition from combination immunotherapy regimens affects its market penetration.
• Revenue forecasts suggest steady growth, with annual increases of 30-50% over the next five years, assuming successful clinical development and regulatory approvals.
• Regional market differences influence sales trajectories, especially considering varying approval timelines and competitive landscapes.
• Cost structure favors profitability at high sales volumes, but market challenges may cap long-term growth.

FAQs

1. Will FOTIVDA gain approval for other indications?
Potentially, if ongoing Phase II trials in other cancers show positive results, regulatory approval could follow, increasing its market footprint.

2. How does FOTIVDA compare price-wise with competitors?
Its price per treatment course is estimated around $9,000–$12,000, comparable to other targeted RCC therapies but subject to regional pricing regulations and negotiations.

3. What are the main barriers to expanding FOTIVDA’s market?
Primarily, competition from immunotherapy combinations and limited current indications restrict growth.

4. How sensitive is FOTIVDA’s financial outlook to regulatory delays?
Delays in approval for new indications or regions could slow revenue growth, impacting projected profitability.

5. Are there partnership or licensing opportunities for FOTIVDA?
Yes. Collaborations with larger pharma companies for combination therapies or new indications could accelerate market penetration.

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References

1. European Medicines Agency. (2021). Tivozanib approved for advanced RCC.
2. AVEO Pharmaceuticals. (2023). Financial report Q2.
3. International Agency for Research on Cancer. (2021). Global Cancer Statistics.

[1] European Medicines Agency. (2021). Tivozanib approval document.
[2] AVEO Pharmaceuticals. (2023). Q2 financial statement.
[3] International Agency for Research on Cancer. (2021). Global cancer data.