ISOVUE-300 Drug Patent Profile

Which patents cover Isovue-300, and what generic alternatives are available?

Isovue-300 is a drug marketed by Bracco and is included in two NDAs.

The generic ingredient in ISOVUE-300 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-300

A generic version of ISOVUE-300 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

Summary for ISOVUE-300

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
DailyMed Link:	ISOVUE-300 at DailyMed

Recent Clinical Trials for ISOVUE-300

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-300 clinical trials

Pharmacology for ISOVUE-300

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

US Patents and Regulatory Information for ISOVUE-300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	018735-002	Dec 31, 1985	AP	RX	Yes	Yes
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	020327-003	Oct 12, 1994		RX	Yes	Yes

Expired US Patents for ISOVUE-300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	018735-002	Dec 31, 1985	4,001,323
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	020327-003	Oct 12, 1994	4,001,323

International Patents for ISOVUE-300

See the table below for patents covering ISOVUE-300 around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	1472050
Yugoslavia	315575
Canada	1046082	DERIVES DE L'ACIDE TRIIODO-2,4,6 ISOPHTHALIQUE (DERIVATIVES OF 2,4,6-TRIIODO-ISOPHTHALIC ACID)
Germany	2547789	5-HYDROXYPROPIONYLAMINO-2,4,6-TRIJOD- ISOPHTHALSAEURE-BIS-(DIHYDROXYPROPYLAMIDE) VERFAHREN ZU IHRER HERSTELLUNG UND DIESE ENTHALTENDE ROENTGENKONTRASTMITTEL
Argentina	211853	PROCEDIMIENTO PARA LA PREPARACION DE LAS NUEVAS BIS-(DIHIDROXIPROPI-AMIDAS)DE ACIDO 5-HIDROXIPROPIONILAMINO-2,4,6-TRIYODOISOFTALICO FACILMENTE SOLUBLES EN AGUA

Market Dynamics and Financial Trajectory for ISOVUE-300

Introduction

ISOVUE-300, a formulation of the contrast agent iopamidol, is widely used in medical imaging procedures to enhance the visibility of organs, tissues, and blood vessels. Understanding the market dynamics and financial trajectory of ISOVUE-300 is crucial for stakeholders, including healthcare providers, investors, and pharmaceutical companies.

Market Overview

The global contrast agents market is driven by the increasing demand for diagnostic imaging procedures, advancements in medical technology, and the rising incidence of chronic diseases. ISOVUE-300, with its various indications, plays a significant role in this market.

Indications and Uses

ISOVUE-300 is indicated for a range of intravascular procedures, including peripheral arteriography, cerebral arteriography, excretory urography, and intravenous contrast enhancement in computed tomography (CT) of the head and body[1][2].

Competitive Landscape

The contrast agents market is highly competitive, with several key players offering similar products. ISOVUE-300 competes with other iopamidol formulations like ISOVUE-200 and ISOVUE-370, as well as products from other manufacturers such as Visipaque and Omnipaque.

Radiopacity and Accuracy

Studies have shown that ISOVUE-370 provides the highest radiopacity and most accurate aneurysm measurements, while ISOVUE-300 may underestimate aneurysmal dimensions. However, ISOVUE-300 remains a viable option due to its stability and efficacy in various procedures[5].

Market Demand

The demand for ISOVUE-300 is influenced by several factors:

Increasing Diagnostic Procedures

The rise in diagnostic imaging procedures due to an aging population and the increasing prevalence of chronic diseases drives the demand for contrast agents like ISOVUE-300.

Technological Advancements

Advancements in CT and other imaging technologies enhance the need for high-quality contrast agents, further boosting the demand for ISOVUE-300.

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in the market dynamics. ISOVUE-300 has been approved for various indications, which supports its market presence[1][2].

Financial Performance

The financial performance of ISOVUE-300 is tied to the overall sales and revenue generated by its manufacturer, Bracco Diagnostics.

Revenue Streams

ISOVUE-300 generates revenue through sales to hospitals, imaging centers, and other healthcare facilities. The product is available in various volumes, including 500 mL, which caters to different procedural needs[3].

Pricing Strategy

The pricing of ISOVUE-300 is competitive, considering the market presence of other contrast agents. The cost-effectiveness and the specific indications for which it is used influence its pricing strategy.

Challenges and Opportunities

Safety and Adverse Reactions

ISOVUE-300, like other contrast agents, can cause adverse reactions. Severe cutaneous adverse reactions (SCAR) and other side effects are potential challenges that affect its market dynamics[4].

Pediatric and Geriatric Use

The product's use in pediatric and geriatric populations presents both opportunities and challenges. Special precautions and dosages are required for these groups, which can impact market growth[1].

Market Trends

Personalized Medicine

The trend towards personalized medicine may influence the use of ISOVUE-300, as healthcare providers seek tailored diagnostic solutions for individual patients.

Cost Containment

Efforts to contain healthcare costs can impact the sales of ISOVUE-300, as healthcare providers may opt for more cost-effective alternatives.

Key Players and Partnerships

Bracco Diagnostics, the manufacturer of ISOVUE-300, plays a significant role in the market. Partnerships with healthcare providers, research institutions, and other pharmaceutical companies can enhance the product's market presence.

Future Outlook

Technological Innovations

Future innovations in imaging technologies and contrast agents could either complement or compete with ISOVUE-300, influencing its market trajectory.

Regulatory Changes

Changes in regulatory environments can significantly impact the market dynamics of ISOVUE-300. Continuous compliance with regulatory standards is crucial for maintaining market share.

Key Takeaways

• ISOVUE-300 is a widely used contrast agent with multiple indications.
• The market is driven by increasing diagnostic procedures and technological advancements.
• Competitive landscape includes other iopamidol formulations and products from different manufacturers.
• Safety and regulatory compliance are critical factors.
• Future outlook is influenced by technological innovations and regulatory changes.

FAQs

What are the primary indications for ISOVUE-300?

ISOVUE-300 is indicated for peripheral arteriography, cerebral arteriography, excretory urography, and intravenous contrast enhancement in CT of the head and body[1][2].

How does ISOVUE-300 compare to other contrast agents in terms of radiopacity?

ISOVUE-300 has lower radiopacity compared to ISOVUE-370 but is still effective for various diagnostic procedures. It may underestimate aneurysmal dimensions compared to ISOVUE-370[5].

What are the potential side effects of ISOVUE-300?

ISOVUE-300 can cause severe cutaneous adverse reactions (SCAR) and other side effects. Special precautions are necessary, especially in pediatric and geriatric populations[1][4].

Who is the primary manufacturer of ISOVUE-300?

The primary manufacturer of ISOVUE-300 is Bracco Diagnostics[3].

How does the regulatory environment impact the market dynamics of ISOVUE-300?

Regulatory approvals and compliance are crucial for the market presence of ISOVUE-300. Changes in regulatory standards can significantly impact its market trajectory[1][2].

Sources

1. Product Monograph ISOVUE® (iopamidol) - Health Canada
2. iopamidol injection, solution ISOVUE 200 - DailyMed
3. Isovue®-300 Iopamidol 61% Injection 500 mL - McKesson
4. 300 ISOVUE®-370 - FDA
5. Differences in radiopacity among CT contrast agents and their impact on aneurysm measurements - Wiley Online Library