ISOVUE-250 Drug Patent Profile

When do Isovue-250 patents expire, and what generic alternatives are available?

Isovue-250 is a drug marketed by Bracco and is included in two NDAs.

The generic ingredient in ISOVUE-250 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-250

A generic version of ISOVUE-250 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

Summary for ISOVUE-250

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	20
Patent Applications:	3,767
Drug Prices:	Drug price information for ISOVUE-250
DailyMed Link:	ISOVUE-250 at DailyMed

See drug prices for ISOVUE-250

Recent Clinical Trials for ISOVUE-250

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-250 clinical trials

Pharmacology for ISOVUE-250

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

US Patents and Regulatory Information for ISOVUE-250

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	ISOVUE-250	iopamidol	INJECTABLE;INJECTION	018735-007	Jul 6, 1992	AP	RX	Yes	Yes
Bracco	ISOVUE-250	iopamidol	INJECTABLE;INJECTION	020327-002	Oct 12, 1994		DISCN	Yes	No

Expired US Patents for ISOVUE-250

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	ISOVUE-250	iopamidol	INJECTABLE;INJECTION	018735-007	Jul 6, 1992
Bracco	ISOVUE-250	iopamidol	INJECTABLE;INJECTION	020327-002	Oct 12, 1994

International Patents for ISOVUE-250

See the table below for patents covering ISOVUE-250 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-250 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ISOVUE-250

Introduction

ISOVUE-250, a nonionic radiopaque contrast medium, is a crucial diagnostic tool in medical imaging. It is used for various angiographic and computed tomographic (CT) procedures. Understanding the market dynamics and financial trajectory of ISOVUE-250 is essential for stakeholders, including healthcare providers, investors, and pharmaceutical companies.

Market Overview

The global contrast agents market, which includes ISOVUE-250, is driven by several key factors:

Increasing Demand for Diagnostic Procedures

The rising incidence of cardiovascular diseases, cancers, and other conditions that require advanced diagnostic imaging drives the demand for contrast agents like ISOVUE-250. Procedures such as angiography, ventriculography, and CT scans are becoming more common, contributing to the growth of this market[4].

Technological Advancements

Advancements in imaging technologies, such as improved CT scanners and MRI machines, enhance the effectiveness of contrast agents. This technological progress increases the accuracy and precision of diagnostic imaging, further boosting the demand for ISOVUE-250[5].

Regulatory Environment

Regulatory approvals and guidelines play a significant role in the market dynamics of ISOVUE-250. The drug is approved for various indications, including angiography throughout the cardiovascular system and CT head and body imaging. Compliance with regulatory standards ensures the safety and efficacy of the product, which is crucial for its market acceptance[2][5].

Competitive Landscape

The contrast agents market is competitive, with several players offering similar products. ISOVUE-250 competes with other nonionic contrast agents such as Omnipaque and Visipaque.

Market Share

ISOVUE-250 holds a significant share in the nonionic contrast agents market due to its wide range of indications and its stability, aqueous, sterile, and nonpyrogenic formulation. The brand's reputation and the extensive use in various medical procedures contribute to its market share[4].

Competitive Strategies

To maintain its market position, Bracco Diagnostics, the manufacturer of ISOVUE-250, employs several strategies. These include continuous research and development to improve the product, strategic partnerships with healthcare providers, and robust marketing efforts to increase awareness among medical professionals.

Financial Performance

The financial performance of ISOVUE-250 is influenced by several factors:

Revenue Growth

The revenue generated by ISOVUE-250 has seen steady growth over the years, driven by the increasing demand for diagnostic imaging procedures. The product's wide range of indications and its use in both adult and pediatric patients contribute to its revenue growth[4].

Cost Structure

The cost structure for ISOVUE-250 includes manufacturing costs, research and development expenses, marketing expenditures, and regulatory compliance costs. Efficient management of these costs is crucial for maintaining profitability.

Pricing Strategies

Pricing strategies for ISOVUE-250 are influenced by market conditions, competition, and regulatory environments. The product is generally priced competitively to ensure market penetration while maintaining profitability.

Indications and Usage

ISOVUE-250 is indicated for a variety of diagnostic procedures, which significantly impacts its market dynamics and financial trajectory.

Angiography

ISOVUE-250 is widely used for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography, and ventriculography. This broad range of angiographic applications contributes substantially to its market demand[2][4].

Computed Tomographic Imaging

The product is also used for contrast enhancement of computed tomographic (CECT) head and body imaging. This includes refining diagnostic precision in areas of the brain and detecting lesions in various body parts, further expanding its market reach[5].

Safety and Efficacy

The safety and efficacy of ISOVUE-250 are critical factors in its market success.

Adverse Reactions

While ISOVUE-250 is generally well-tolerated, it can cause adverse reactions such as allergic reactions and renal impairment in some patients. Managing these risks through proper patient selection and monitoring is essential for maintaining market confidence[2][5].

Clinical Trials and Studies

Continuous clinical trials and studies to evaluate the safety and efficacy of ISOVUE-250 help in reinforcing its market position. Positive outcomes from these studies can lead to expanded indications and increased usage.

Patient Counseling and Education

Patient counseling and education are vital components of the market strategy for ISOVUE-250.

Patient Information

Providing clear and comprehensive patient information about the benefits and risks of ISOVUE-250 helps in building trust and ensuring compliance. This includes informing patients about potential side effects and the importance of follow-up care[2].

Healthcare Provider Education

Educating healthcare providers about the proper use, dosages, and precautions associated with ISOVUE-250 is crucial. This ensures that the product is used effectively and safely, which in turn enhances its market reputation.

Storage and Handling

The storage and handling of ISOVUE-250 are important for maintaining its efficacy and safety.

Pharmacy Bulk Packages

ISOVUE-250 is available in pharmacy bulk packages, which allows for multiple single-dose preparations. Proper storage and handling procedures must be followed to ensure the sterility and stability of the product[2][5].

Key Takeaways

• Market Growth: The demand for ISOVUE-250 is driven by the increasing need for diagnostic imaging procedures.
• Competitive Landscape: ISOVUE-250 competes with other nonionic contrast agents but holds a significant market share due to its wide range of indications.
• Financial Performance: Revenue growth is steady, influenced by the product's extensive use in various medical procedures.
• Safety and Efficacy: Continuous clinical trials and studies reinforce the safety and efficacy of ISOVUE-250.
• Patient and Provider Education: Clear patient information and healthcare provider education are essential for the safe and effective use of the product.

Frequently Asked Questions

Q: What are the primary indications for ISOVUE-250? A: ISOVUE-250 is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography, and ventriculography, as well as for CT head and body imaging[2][4].

Q: Is ISOVUE-250 suitable for intrathecal use? A: No, ISOVUE-250 is not for intrathecal use. It is specifically designed for intravascular administration[2][5].

Q: What are the common side effects of ISOVUE-250? A: Common side effects include allergic reactions and renal impairment. Proper patient selection and monitoring are essential to manage these risks[2][5].

Q: How is ISOVUE-250 stored and handled? A: ISOVUE-250 is available in pharmacy bulk packages and must be stored and handled according to specific guidelines to maintain sterility and stability[2][5].

Q: What is the role of ISOVUE-250 in computed tomographic imaging? A: ISOVUE-250 is used for contrast enhancement of computed tomographic (CECT) head and body imaging, helping to refine diagnostic precision and detect lesions in various body parts[5].

Sources Cited

1. Drugs.com: ISOVUE (lopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intravascular administration[1].
2. Drugs.com: ISOVUE 250 (Iopamidol Injection) is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, pediatric angiocardiography, selective visceral arteriography and aortography, peripheral venography (phlebography), and adult and pediatric intravenous excretory urography[2].
3. McKesson: ISOVUE®-250 Iopamidol 51% Injection 200 mL by Bracco Diagnostics[3].
4. Bracco Diagnostics: ISOVUE®-200, -250, -300, -370 (Iopamidol Injection) INDICATION[4].
5. FDA: ISOVUE (lopamidol Injection) enhances computed tomographic brain imaging through augmentation of radiographic efficiency[5].