TIVOZANIB HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for tivozanib hydrochloride and what is the scope of freedom to operate?

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:	36
Patent Applications:	750
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
M.D. Anderson Cancer Center	Phase 2
Genentech, Inc.	Phase 1/Phase 2
Aveo Oncology Pharmaceuticals	Phase 1/Phase 2

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

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	212904-001	Mar 10, 2021		RX	Yes	No
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			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			Y	Y

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
Aveo Pharms	FOTIVDA	tivozanib hydrochloride	CAPSULE;ORAL	212904-001	Mar 10, 2021

International Patents for TIVOZANIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Brazil	0209216
Japan	3763414
Belgium	2018C008
Chile	2021001172	Uso de tivozanib para tratar sujetos con cáncer refractario.
China	1543459

Supplementary Protection Certificates for TIVOZANIB HYDROCHLORIDE

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
1382604	122018000018	Germany		PRODUCT NAME: TIVOZANIB ODER EIN SALZ ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/17/1215 20170824
1382604	300927	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
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	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

TIVOZANIB HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tivozanib Hydrochloride (Fotivda)

Introduction

Tivozanib hydrochloride, marketed as Fotivda, is a significant addition to the treatment arsenal for renal cell carcinoma (RCC), particularly for patients with relapsed or refractory advanced RCC. Here, we delve into the market dynamics and financial trajectory of this drug since its launch.

FDA Approval and Market Launch

Tivozanib received FDA approval on March 10, 2021, for the treatment of adult patients with relapsed or refractory advanced RCC who have received two or more prior systemic therapies. This approval was based on data from the phase 3 TIVO-3 trial, which demonstrated a significant improvement in progression-free survival (PFS) compared to sorafenib[1].

Clinical Efficacy and Patient Benefits

The TIVO-3 trial showed that tivozanib led to a median PFS of 5.6 months, compared to 3.9 months for sorafenib, with a hazard ratio (HR) of 0.73 (P = .016). The trial also indicated that patients who previously received a checkpoint inhibitor and VEGF inhibitor, or two VEGF TKIs, derived the greatest benefit from tivozanib, with HRs of 0.55 and 0.57, respectively[1].

Market Reception and Commercial Performance

Since its launch, Fotivda has shown strong commercial performance. In the second quarter of 2022, U.S. net product revenue for Fotivda increased by 24% to $25.0 million compared to the first quarter of 2022, and by 271% compared to the second quarter of 2021. This growth is attributed to increased prescriptions and a robust commercial strategy[3].

Prescription Trends

The number of commercial prescriptions filled for Fotivda has been on the rise. In the second quarter of 2022, 1,157 commercial prescriptions were filled, representing an 18% increase from the first quarter of 2022 and a 309% increase from the second quarter of 2021[3].

Market Positioning

AVEO Oncology has been recognized for its successful commercial launch of Fotivda. The company received the “Distinguished Excellence” Award at the 28th Annual Communicator Awards for its multi-media and public relations campaign supporting the launch. Additionally, Fotivda was elevated to a Category 1 treatment for relapsed or refractory RCC patients in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines[3].

Financial Projections and Guidance

For the full year 2022, AVEO Oncology reaffirmed its U.S. net product revenue guidance for Fotivda to be between $100.0 million and $110.0 million. The company also streamlined its planned R&D spending, reducing the guidance from $60.0 million to $70.0 million to $50.0 million for 2022[3].

Revenue Growth

The revenue growth of Fotivda has been substantial. From $6.7 million in the second quarter of 2021 to $25.0 million in the second quarter of 2022, the drug has demonstrated a significant market uptake. This growth is expected to continue, driven by the drug's efficacy and the company's robust commercial strategy[3].

Research and Development (R&D) Initiatives

AVEO Oncology is continuing to invest in clinical development programs to expand the commercial opportunity of tivozanib. One notable initiative is the Phase 3 TiNivo-2 clinical trial, which is evaluating tivozanib in combination with nivolumab (OPDIVO) in patients with relapsed or refractory RCC who have progressed following prior immune checkpoint inhibitor therapy. If successful, this trial could support FDA approval of the combination therapy and expand the market opportunity for Fotivda[3].

Cost and Access Programs

To ensure patient access, AVEO Oncology has implemented the AVEO ACE assistance program. This program is designed to optimize patient access and help patients navigate their treatment journey, reflecting the company's commitment to the RCC community[1].

Stability and Quality Assurance

Tivozanib hydrochloride has demonstrated good chemical and physical stability under various conditions, including light exposure and temperature excursions. This stability is crucial for maintaining the drug's efficacy and ensuring patient safety[4].

Industry Recognition and Awards

AVEO Oncology's commercial launch of Fotivda has been recognized by industry experts. The company received an award for its commercial launch and was praised for its multi-media and public relations campaign, indicating strong market acceptance and execution[3].

Future Outlook

The future outlook for tivozanib hydrochloride is promising. With ongoing clinical trials and a strong commercial performance, the drug is poised to continue its market dominance in the RCC treatment landscape. The potential approval of the combination therapy with nivolumab could further expand its market opportunity.

Potential Expansion into New Indications

AVEO Oncology is also exploring other potential indications for tivozanib, such as its use in combination with other therapies for different types of cancer. This strategic approach could further diversify the drug's revenue streams and solidify its position in the oncology market[3].

Key Takeaways

• FDA Approval: Tivozanib received FDA approval in March 2021 for relapsed or refractory advanced RCC.
• Clinical Efficacy: Demonstrated significant improvement in PFS compared to sorafenib.
• Commercial Performance: Strong revenue growth with $25.0 million in U.S. net product revenue in Q2 2022.
• Market Positioning: Elevated to Category 1 treatment in NCCN guidelines and recognized for commercial launch excellence.
• Financial Projections: Full-year 2022 revenue guidance of $100.0 million to $110.0 million.
• R&D Initiatives: Ongoing clinical trials, including the Phase 3 TiNivo-2 trial.
• Cost and Access Programs: AVEO ACE assistance program to optimize patient access.

FAQs

What is tivozanib hydrochloride used for?

Tivozanib hydrochloride, marketed as Fotivda, is used for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) who have received two or more prior systemic therapies.

When was tivozanib approved by the FDA?

Tivozanib was approved by the FDA on March 10, 2021.

What are the key findings from the TIVO-3 trial?

The TIVO-3 trial showed that tivozanib led to a significant improvement in progression-free survival (PFS) compared to sorafenib, with a median PFS of 5.6 months versus 3.9 months, respectively.

How has the commercial performance of Fotivda been since its launch?

Fotivda has shown strong commercial performance, with U.S. net product revenue increasing by 24% in Q2 2022 compared to Q1 2022 and by 271% compared to Q2 2021.

What are the ongoing R&D initiatives for tivozanib?

AVEO Oncology is conducting the Phase 3 TiNivo-2 clinical trial to evaluate tivozanib in combination with nivolumab in patients with relapsed or refractory RCC.

Sources

1. Urology Times: "Tivozanib officially launched in US kidney cancer market"
2. RxStrategies: "Clinical Insights: April 6, 2021"
3. AVEO Oncology: "AVEO Oncology Reports Second Quarter 2022 Financial Results"
4. FDA: "212904Orig1s000 - accessdata.fda.gov"