FOTIVDA Drug Patent Profile

Which patents cover Fotivda, and when can generic versions of Fotivda launch?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FOTIVDA

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

International Patents for FOTIVDA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2019375972
Brazil	112021008606
Canada	3118690
Chile	2021001172

Supplementary Protection Certificates for FOTIVDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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	300927	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME

FOTIVDA (Tevinebascam): Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

FOTIVDA (tevinebascam) is an oral small-molecule inhibitor approved for the treatment of adult patients with locally advanced or metastatic renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. Since its U.S. FDA approval in December 2021, FOTIVDA has positioned itself within a competitive oncology landscape characterized by a growing RCC market, evolving treatment protocols, and increasing demand for targeted therapies. This report evaluates the current market dynamics, projective financial trajectories, and identifies potential investment opportunities, risks, and strategic considerations surrounding FOTIVDA.

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1. Market Overview and Dynamics

1.1 Renal Cell Carcinoma (RCC): Size and Growth

Key Data Points	Details
Global RCC Market Size (2022)	$5.1 billion (expected to reach $8.2 billion by 2030, CAGR 6.2%)[1]
U.S. RCC Incidence (2023)	Approx. 81,180 new cases; 14,890 deaths (SEER, 2023)
Key Demographics	Peak incidence in 60-70-year-olds; male predominance (2:1)

The RCC market is driven by rising incidence, enhanced detection via imaging, and increasing awareness.

1.2 Therapeutic Landscape

Treatment Modality	Market Share (2022)	Notes
Anti-angiogenic agents	45%	VEGF inhibitors, e.g., sunitinib, pazopanib
Immune checkpoint inhibitors	35%	Nivolumab, pembrolizumab combination therapies
mTOR inhibitors	15%	Everolimus
Targeted small-molecule inhibitors	5%	Includes FOTIVDA and others

Key Point: FOTIVDA enters a landscape dominated by VEGF and immune checkpoint inhibitors, with increasing adoption of combination therapies.

1.3 Regulatory and Clinical Positioning

• Approval Details: FDA approved FOTIVDA in December 2021.
• Indication: Treatment of adult patients with locally advanced or metastatic RCC following anti-angiogenic therapy.
• Clinical Data: Phase 3 TIVO-3 trial demonstrated a median progression-free survival (PFS) of 5.6 months versus 3.7 months for placebo (hazard ratio 0.66, p<0.001). Overall survival data are mature with ongoing analysis.

1.4 Competitive Positioning

Competitor	Key Drug(s)	Market Share	Strengths	Weaknesses
Cabozantinib	Cabometyx	~22%	Multi-kinase inhibition, metastasis targeting	Side-effect profile
Axitinib	Inlyta	~13%	High selectivity	Resistance issues
Nivolumab + Ipilimumab	Opdivo + Yervoy	~20%	Durable responses	Higher cost, immune-related adverse events
Lenvatinib + Everolimus		~8%	Combination efficacy	Toxicity

FOTIVDA's positioning hinges on its efficacy in pre-treated RCC and the niche it can carve following anti-angiogenic therapy.

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2. Financial Trajectory and Investment Perspective

2.1 Current Sales and Revenue

Financial Metrics	2022	2023 (Projected)	Notes
Revenues (USD millions)	~$150	~$300	Based on initial uptake and reimbursement coverage
Prescription Volume	8,000+ units	20,000+ units	Approximate annual growth rate of 50%

2.2 Revenue Drivers

• Market Penetration: Expanding from early adopters to broader oncologist networks.
• Pricing Strategy: Established via competitive pricing aligned with advanced RCC treatments (~$10,000/month in US).
• Reimbursement Dynamics: Favorable coverage under major insurers, including Medicare and commercial payers.
• Pipeline and Label Expansion: Potential for broader line treatment approval and combination therapy synergies.

2.3 Cost Structure and Profitability

Cost Component	% of Revenue	Notes
R&D Investment	10-15%	Ongoing clinical trials and pipeline expansion
Marketing & Sales	20-25%	Specialty sales forces targeting oncologists
Manufacturing	5-10%	Scale economies reducing per-unit costs
Operating Expenses	40-50%	Infrastructure, administration

Projected gross margin approaches 70-75%, assuming economies of scale and stable supply chain.

2.4 Forecasted Market Share and Revenue Growth

Year	Projected Market Share	Estimated Revenue (USD millions)	Key Assumptions
2023	2-3%	$300	Launch momentum, initial adoption
2024	5-7%	$600	Increased clinician familiarity, expanded indications
2025	10%	$1.2 billion	Capitation-driven growth, possibly in combination therapies

Note: Achieving these figures depends on clinical validation, market access, and payer acceptance.

2.5 Investment Risks and Challenges

• Intense Competition: Existing franchises hold dominant market shares.
• Regulatory Hurdles: Future approvals depend on ongoing trials.
• Market Penetration: Adoption accelerated by clinical guidelines integration.
• Pricing Pressures: Potential for reimbursement constraints.
• Pipeline Dependence: Reliance on pipeline success for sustained growth.

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3. Strategic Considerations for Investors

3.1 Growth Opportunities

• Combination Therapy Approval: Potential to combine FOTIVDA with immune checkpoint inhibitors, expanding indications.
• Geographic Expansion: Entry into EU, Asia, and other markets.
• Broader Oncology Indications: Exploration in other tumor types reliant on similar pathways.

3.2 Partnership and Licensing Deals

The company’s strategy to partner with biopharma giants for co-development and commercialization could accelerate growth and reduce risk.

3.3 Pipeline Development and R&D

Focus on expanding the clinical footprint with trials targeting:

Indications	Status	Expected Completion	Potential Impact
Non-RCC tumors	Phase 2	2024-2025	Diversify revenue streams
Combination studies	Ongoing	2024	Enhance efficacy and market adoption

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4. Comparison Table: FOTIVDA vs. Major Competitors

Attribute	FOTIVDA	Cabozantinib (Cabometyx)	Axitinib (Inlyta)	Nivolumab + Ipilimumab	Lenvatinib + Everolimus
Approval Year	2021	2016	2012	2018	2018
Mode of Action	Tyrosine kinase inhibitor	Multi-kinase inhibitor	VEGFR inhibitor	Immune checkpoint	Multi-kinase + mTOR
Key Indication	RCC post-therapy	RCC	RCC	RCC	RCC
1st-line Use	No	Yes	Yes	Yes	Yes
Median PFS	5.6 months	8.2 months	6.7 months	Data mature	7.4 months
Common Side Effects	Fatigue, hypertension	Diarrhea, hypertension	Hypertension, fatigue	Immune-related	Hypertension, proteinuria

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5. FAQs

Q1: What is the primary differentiator for FOTIVDA in the RCC market?
A: Its approval for patients post-anti-angiogenic therapy positions it as a targeted option for a specific niche, filling an unmet need in second-line RCC treatment.

Q2: What are the main risks for investors considering FOTIVDA?
A: Market saturation by existing therapies, slow uptake due to clinician familiarity with competitors, regulatory challenges, and potential pricing or reimbursement constraints.

Q3: How does FOTIVDA’s efficacy compare to leading competitors?
A: Phase 3 data indicate median PFS comparable to other TKIs, but head-to-head data are absent. Its niche is primarily second-line, where it competes on tolerability and safety.

Q4: What is the outlook for FOTIVDA's pipeline expansion?
A: Pending clinical trials may broaden its therapeutic scope, including potential in other solid tumors, which could significantly alter its market trajectory.

Q5: How should investors evaluate FOTIVDA’s growth potential?
A: Focus on clinical validation, market access strategies, partnership developments, and pipeline progress, aligning these with RCC market trends and competitive positioning.

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Key Takeaways

• FOTIVDA holds a strategic niche as a second-line RCC therapy in a growing and competitive market.
• Its commercial success hinges on clinician adoption, reimbursement, and pipeline expansion.
• Revenue projections suggest substantial growth potential, but face headwinds from entrenched competitors.
• Strategic collaborations and clinical development are vital for sustainability.
• The expanding RCC market, along with potential in combination therapies and new indications, offers pathways for value creation.

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References

[1] Grand View Research. (2022). Renal Cell Carcinoma Market Size, Share & Trends Analysis.
[2] SEER Program. (2023). Cancer Statistics Review.
[3] FDA. (2021). FOTIVDA (tevinebascam) approval documents.
[4] EvaluatePharma. (2022). World Preview of Oncology Drugs Market.
[5] ClinicalTrials.gov. (2023). FOTIVDA clinical trial data and pipeline information.