ISOVUE-128 Drug Patent Profile

When do Isovue-128 patents expire, and what generic alternatives are available?

Isovue-128 is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in ISOVUE-128 is iopamidol. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iopamidol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Isovue-128

A generic version of ISOVUE-128 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

Summary for ISOVUE-128

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	20
Patent Applications:	3,526
DailyMed Link:	ISOVUE-128 at DailyMed

Recent Clinical Trials for ISOVUE-128

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
NYU Langone Health	N/A
M.D. Anderson Cancer Center	N/A
National Cancer Institute (NCI)	N/A

See all ISOVUE-128 clinical trials

Pharmacology for ISOVUE-128

Drug Class	Radiographic Contrast Agent
Mechanism of Action	X-Ray Contrast Activity

US Patents and Regulatory Information for ISOVUE-128

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	ISOVUE-128	iopamidol	INJECTABLE;INJECTION	018735-005	Oct 21, 1986		DISCN	No	No

International Patents for ISOVUE-128

See the table below for patents covering ISOVUE-128 around the world.

Country	Patent Number	Title	Estimated Expiration
Switzerland	608189
Canada	1046082	DERIVES DE L'ACIDE TRIIODO-2,4,6 ISOPHTHALIQUE (DERIVATIVES OF 2,4,6-TRIIODO-ISOPHTHALIC ACID)
Austria	349449
Bulgaria	26512
Norway	145096
United Kingdom	1472050

ISOVUE-128 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of ISOVUE-128

Introduction

ISOVUE-128, a formulation of Iopamidol Injection, is a widely used contrast medium in medical imaging. It is utilized in various diagnostic procedures, including angiography, computed tomographic (CT) imaging, and intravenous excretory urography. Here, we delve into the market dynamics and financial trajectory of ISOVUE-128.

Market Indications and Usage

ISOVUE-128 is indicated for several medical imaging procedures, including:

• Angiography throughout the cardiovascular system
• Peripheral venography (phlebography)
• Adult and pediatric intravenous excretory urography
• Intravenous adult and pediatric contrast enhancement of computed tomographic (CECT) head and body imaging[2][3].

This broad range of indications positions ISOVUE-128 as a versatile and essential tool in diagnostic medicine.

Market Demand

The demand for ISOVUE-128 is driven by the increasing need for advanced diagnostic imaging in healthcare. With the rise in chronic diseases, such as cardiovascular conditions and cancers, the requirement for precise and detailed imaging has grown significantly. This trend is expected to continue, fueled by an aging population and advancements in medical technology.

Competitive Landscape

The market for contrast media is competitive, with several players offering similar products. However, ISOVUE-128 stands out due to its stability, aqueous and nonpyrogenic nature, and its approval for multidose use in the form of the ISOVUE Imaging Bulk Package. This bulk package option improves sustainability, reduces costs associated with contrast waste, and enhances resource efficiency[4].

Financial Performance

Revenue and Pricing

ISOVUE-128 is a significant revenue generator for its manufacturer, Bracco Diagnostics Inc. The pricing of ISOVUE-128 can vary depending on the volume and concentration of the solution. For example, a 20 mL vial of ISOVUE-200 (which is similar in formulation to ISOVUE-128) can cost around $132[5].

Cost Efficiency

The introduction of the ISOVUE Imaging Bulk Package has been a strategic move to reduce costs and improve efficiency. This multidose option allows for on-demand dosing, reducing waste and the overall cost per patient. This approach not only benefits healthcare providers financially but also aligns with sustainability goals[4].

Regulatory Environment

ISOVUE-128 is regulated by stringent safety and efficacy standards. It has been approved by the FDA for various indications and is manufactured in compliance with OSHA HCS guidelines. The safety data sheet highlights its stability under normal conditions and the absence of dangerous reactions with other substances[1][2].

Pharmacokinetics and Safety Profile

The pharmacokinetics of iopamidol, the active ingredient in ISOVUE-128, show that it does not significantly bind to serum or plasma proteins and does not cross the blood-brain barrier. This profile contributes to its safety and efficacy in diagnostic imaging. The contrast agent is primarily excreted through the kidneys, with optimal contrast visualization occurring within minutes of administration[2][3].

Market Trends and Innovations

The market for contrast media is evolving with technological advancements and changing healthcare needs. The trend towards sustainability and cost efficiency is evident in the development of bulk packaging solutions like ISOVUE Imaging Bulk Package. Additionally, the integration of advanced imaging techniques, such as dynamic CT scanning, enhances the diagnostic capabilities of ISOVUE-128[3][4].

Key Takeaways

• Broad Indications: ISOVUE-128 is used in a wide range of diagnostic imaging procedures.
• Competitive Advantage: The ISOVUE Imaging Bulk Package offers cost efficiency and sustainability.
• Regulatory Compliance: Strict adherence to FDA and OSHA guidelines ensures safety and efficacy.
• Pharmacokinetics: Iopamidol’s favorable pharmacokinetic profile supports its use in various imaging procedures.
• Market Trends: The market is driven by the need for advanced diagnostic tools and sustainable practices.

FAQs

What are the primary indications for ISOVUE-128?

ISOVUE-128 is indicated for angiography, peripheral venography, intravenous excretory urography, and contrast enhancement of computed tomographic (CECT) head and body imaging.

How does the ISOVUE Imaging Bulk Package benefit healthcare providers?

The ISOVUE Imaging Bulk Package reduces costs associated with contrast waste, improves sustainability, and allows for on-demand dosing, making it a more efficient and cost-effective option.

What are the key pharmacokinetic properties of iopamidol in ISOVUE-128?

Iopamidol does not significantly bind to serum or plasma proteins, does not cross the blood-brain barrier, and is primarily excreted through the kidneys.

How does ISOVUE-128 enhance diagnostic imaging?

ISOVUE-128 enhances diagnostic imaging by increasing x-ray absorption, allowing for better visualization of tissues and lesions, particularly when used in dynamic CT scanning techniques.

What are the regulatory standards that ISOVUE-128 must comply with?

ISOVUE-128 must comply with FDA regulations and OSHA HCS guidelines to ensure safety and efficacy.

Sources

1. Medline: Safety Data Sheet - Isovue 128, 200, 250, 300, 370 solutions.
2. FDA: ISOVUE® (Iopamidol Injection) - accessdata.fda.gov.
3. FDA: ISOVUE® (Iopamidol Injection) - accessdata.fda.gov (2023 update).
4. ISOVUE: ISOVUE - ISOVUE.
5. St. Anthony Hospital Pendleton: Financial Data - Sheet1.