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FOTIVDA

NDA

TIVOZANIB HYDROCHLORIDE | N212904 | AVEO PHARMACEUTICALS INC

2 strengths2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Active (2)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

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2038

2039

2040

Today

7166722

Nov. 16, 2028

11504365

Nov. 5, 2039

NCE

Mar. 10, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents (3 active) from PACER

Case	Court	Filed	Status	Judge
AVEO Pharmaceuticals, Inc. v. Glenmark Pharmaceuticals Inc. USA et al 1:2025cv00735 3 patentsANDA 220307tivozanib hydrochloride	D. Del.	2025-06-13	Active	—
AVEO Pharmaceuticals, Inc. v. Hetero USA Inc. et al 1:2025cv00639 3 patentsANDA 220437tivozanib hydrochloride	D. Del.	2025-05-23	Active	—
AVEO Pharmaceuticals, Inc. v. Somerset Therapeutics, LLC et al 1:2025cv00560 3 patentsANDA 220384tivozanib hydrochloride	D. Del.	2025-05-07	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Fotivda (2023)

Total Spending

$102.3M

Total Claims

3,638

Beneficiaries

923

Avg Cost/Unit

$1365.09

Spending Trend

$22.5M(2021)→$72.7M(2022)→$102.3M(2023)

YoY Change:+7.2%

5yr CAGR:+7.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

SYNTHON BVTIVOZANIB HYDROCHLORIDE MONOHYDRATE

DMF 402892024

VALARY LAB PRIVATE LTDTIVOZANIB HYDROCHLORIDE MONOHYDRATE

DMF 408062024

ALIVUS LIFE SCIENCES LTDTIVOZANIB HYDROCHLORIDE

DMF 409922024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Feb 6, 2025	SUPPL -3	View Letter (PDF)
Aug 8, 2024	SUPPL -2	View Letter (PDF)
Mar 11, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 0.89MG BASE

RLD

2 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Mar 10, 2021

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7166722	Nov 16, 2028	—	Yes	Yes	—	—
11504365	Nov 5, 2039	—	—	—		—

Exclusivities (1)

Code	Date	Status
NCE	Mar 10, 2026	Expired

#002 — EQ 1.34MG BASE

RLD

2 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Mar 10, 2021