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
Patent Applications:	21
Drug Prices:	Drug price information 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
University of Florida	Phase 1/Phase 2
Genentech, Inc.	Phase 1/Phase 2
Aveo Oncology Pharmaceuticals	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	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

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	6,821,987
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-002	Mar 10, 2021	6,821,987

International Patents for FOTIVDA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20040015143
European Patent Office	3876934	UTILISATION DE TIVOZANIB POUR TRAITER DES SUJETS ATTEINTS D'UN CANCER RÉFRACTAIRE (USE OF TIVOZANIB TO TREAT SUBJECTS WITH REFRACTORY CANCER)
Russian Federation	2003134376

Supplementary Protection Certificates for FOTIVDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	600	Finland
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 FOTIVDA

Introduction to FOTIVDA

FOTIVDA, known chemically as tivozanib, is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) developed by AVEO Oncology. It is specifically approved for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies[1][3][4].

FDA Approval and Market Entry

After a long and challenging journey, FOTIVDA received FDA approval on March 10, 2021, marking a significant milestone for AVEO Oncology. This approval was based on the positive results of the Phase 3 TIVO-3 trial, which compared tivozanib to Bayer’s Nexavar. The trial demonstrated that FOTIVDA delayed cancer progression for a median of 5.6 months, compared to 3.9 months for Nexavar, and showed a higher response rate to treatment[4].

Commercial Launch and Sales Performance

The commercial launch of FOTIVDA began in the last week of March 2021, with initial net product revenue of $1.1 million from distributor orders. By the end of the first quarter, all distributors had placed reorders for the second quarter, indicating early commercial success. As of April 30, 2021, 49 prescriptions had been filled, and 75 samples had been requested and delivered[3].

By the second quarter of 2022, FOTIVDA's U.S. net product revenue had increased significantly, reaching $25.0 million, a 24% growth compared to the first quarter of 2022. This growth trajectory continued, with total revenue for the second quarter of 2022 being approximately $25.3 million, a substantial increase from $7.6 million in the second quarter of 2021[1].

Market Position and Competitive Advantage

FOTIVDA holds a unique position in the market as the only drug specifically approved for the treatment of relapsed or refractory advanced RCC in the third-line setting. Its safety profile and tolerability are key selling points, particularly when compared to other treatments like Nexavar. The drug's inclusion in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines further solidifies its market position[1][3][4].

Financial Guidance and Projections

AVEO Oncology has provided robust financial guidance for FOTIVDA. For the full year 2022, the company reaffirmed its U.S. net product revenue guidance for FOTIVDA at $100.0 million to $110.0 million. Commercial expenses were expected to be approximately $50.0 million, with general and administrative expenses remaining around $20.0 million for the year. Research and development expenses were reduced to $50.0 million, focusing on clinical development programs that expand the commercial opportunity of tivozanib and position other product candidates for partnering opportunities[1].

Cash and Funding

As of June 30, 2022, AVEO reported $77.2 million in cash, cash equivalents, and marketable securities. This financial position, combined with expected net product revenues from FOTIVDA sales, is expected to support the company's operations for more than 12 months from the date of the Quarterly Report on Form 10-Q[1].

In the first quarter of 2021, AVEO strengthened its balance sheet by adding approximately $78.1 million through various financial transactions, including a loan agreement with Hercules Capital and a public offering of common stock[2][3].

Research and Development

AVEO Oncology is actively involved in clinical trials to further establish FOTIVDA's efficacy and expand its indications. The Phase 3 TiNivo-2 trial, which combines FOTIVDA with OPDIVO (nivolumab), is on track to complete patient enrollment in the second quarter of 2023. This trial is part of a broader strategy to leverage partnerships for funding the development of pipeline assets while retaining North American oncology commercial rights[1].

Market Size and Potential

The U.S. market for relapsed or refractory advanced RCC therapy is substantial, estimated to be over $1.7 billion, with $1.3 billion in the second line and $480 million in the third and fourth lines. Given FOTIVDA's unique approval status and positive clinical trial results, the drug is poised to capture a significant share of this market[5].

Challenges and Opportunities

Despite the positive market dynamics, the launch of FOTIVDA has faced some challenges, including a protracted launch curve compared to pre-COVID times. However, the company remains optimistic about the drug's commercial potential, citing its safety profile, tolerability, and the lack of other approved treatments in the third-line setting[5].

Industry Expert Insights

Analysts such as Andrew Berens from SVB Leerink have highlighted FOTIVDA's potential to carve a meaningful niche in its approved setting. The drug's safety record and tolerability are seen as key advantages, and projections suggest peak sales could reach $417 million[4].

Key Takeaways

• FDA Approval: FOTIVDA received FDA approval on March 10, 2021, for the treatment of relapsed or refractory advanced RCC.
• Commercial Success: The drug has shown significant growth in sales, with a 24% increase in U.S. net product revenue from Q1 to Q2 2022.
• Market Position: FOTIVDA is the only drug specifically approved for third-line RCC treatment, offering a unique market position.
• Financial Guidance: AVEO expects FOTIVDA U.S. net product revenue to be between $100.0 million to $110.0 million for the full year 2022.
• Research and Development: Ongoing clinical trials, including the Phase 3 TiNivo-2 trial, aim to expand FOTIVDA's indications and commercial potential.
• Market Potential: The U.S. market for relapsed or refractory advanced RCC therapy is estimated to be over $1.7 billion.

FAQs

Q: What is FOTIVDA, and what is it used for? A: FOTIVDA (tivozanib) is an oral VEGFR TKI used for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

Q: When did FOTIVDA receive FDA approval? A: FOTIVDA received FDA approval on March 10, 2021.

Q: What are the key advantages of FOTIVDA over other treatments? A: FOTIVDA's safety profile, tolerability, and its status as the only approved drug in the third-line RCC setting are its key advantages.

Q: What are the financial projections for FOTIVDA in 2022? A: AVEO expects FOTIVDA U.S. net product revenue to be between $100.0 million to $110.0 million for the full year 2022.

Q: What ongoing clinical trials are significant for FOTIVDA? A: The Phase 3 TiNivo-2 trial, which combines FOTIVDA with OPDIVO (nivolumab), is a significant ongoing trial aimed at expanding FOTIVDA's commercial opportunity.

Cited Sources

1. AVEO Oncology Reports Second Quarter 2022 Financial Results - AVEO Oncology.
2. AVEO Oncology Reports First Quarter 2021 Financial Results and Provides Business Update - Business Wire.
3. AVEO Oncology Reports First Quarter 2021 Financial Results and Provides Business Update - AVEO Oncology.
4. Aveo's tivozanib, now approved as Fotivda, will hit the market after years of setbacks - FiercePharma.
5. AVEO PHARMACEUTICALS, INC. - Annual Reports - AnnualReports.com.

Last updated: 2024-12-17