ISOVUE-200 Drug Patent Profile

Which patents cover Isovue-200, and when can generic versions of Isovue-200 launch?

Isovue-200 is a drug marketed by Bracco and is included in two NDAs.

The generic ingredient in ISOVUE-200 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-200

A generic version of ISOVUE-200 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

Summary for ISOVUE-200

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	20
Patent Applications:	3,675
Drug Prices:	Drug price information for ISOVUE-200
DailyMed Link:	ISOVUE-200 at DailyMed

See drug prices for ISOVUE-200

Recent Clinical Trials for ISOVUE-200

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

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

See all ISOVUE-200 clinical trials

Pharmacology for ISOVUE-200

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

US Patents and Regulatory Information for ISOVUE-200

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	ISOVUE-200	iopamidol	INJECTABLE;INJECTION	018735-006	Jul 7, 1987	AP2	RX	Yes	Yes
Bracco	ISOVUE-200	iopamidol	INJECTABLE;INJECTION	020327-001	Oct 12, 1994		DISCN	No	No

Expired US Patents for ISOVUE-200

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	ISOVUE-200	iopamidol	INJECTABLE;INJECTION	020327-001	Oct 12, 1994	4,001,323

International Patents for ISOVUE-200

See the table below for patents covering ISOVUE-200 around the world.

Country	Patent Number	Title	Estimated Expiration
Bulgaria	26512
Denmark	567475
Germany	2547789	5-HYDROXYPROPIONYLAMINO-2,4,6-TRIJOD- ISOPHTHALSAEURE-BIS-(DIHYDROXYPROPYLAMIDE) VERFAHREN ZU IHRER HERSTELLUNG UND DIESE ENTHALTENDE ROENTGENKONTRASTMITTEL
Philippines	12321	WATER-SOLUBLE,NON-IONIXING DERIVATIVES OF 2,4,6-TRIIODO-ISOPHTHALIC ACID
Yugoslavia	40448

Market Dynamics and Financial Trajectory for ISOVUE-200

Introduction

ISOVUE-200, a nonionic radiopaque contrast medium, is a crucial component in various medical imaging procedures. Understanding its market dynamics and financial trajectory is essential for stakeholders, including healthcare providers, pharmaceutical companies, and investors.

Market Indications and Usage

ISOVUE-200 is indicated for a wide range of diagnostic procedures, including angiography throughout the cardiovascular system, cerebral and peripheral arteriography, coronary arteriography, ventriculography, pediatric angiocardiography, and intravenous excretory urography. It is also used for contrast enhancement in computed tomographic (CECT) head and body imaging[1][3][4].

Competitive Landscape

The market for contrast media is competitive, with several other nonionic and ionic contrast agents available. However, ISOVUE-200 stands out due to its stability, aqueous formulation, and nonpyrogenic properties. The introduction of the ISOVUE Imaging Bulk Package, which allows for multidose use, has enhanced its market position by improving sustainability, reducing costs associated with contrast waste, and offering a compliant multidose contrast option[2].

Pricing and Cost Considerations

The cost of ISOVUE-200 can vary depending on the pharmacy and location. For instance, a supply of 2000 milliliters of ISOVUE-200 41% injectable solution can cost around $680 for cash payments[5].

Financial Trajectory

Revenue Generation

The revenue generated by ISOVUE-200 is influenced by its widespread use in diagnostic imaging. Given its broad indications, it is a staple in many radiology departments. The financial performance of ISOVUE-200 is likely to remain strong due to the consistent demand for high-quality contrast media in medical imaging.

Cost Savings and Efficiency

The ISOVUE Imaging Bulk Package has introduced significant cost savings by reducing waste and allowing for on-demand dosing. This multidose format can help healthcare facilities manage their resources more efficiently, which can positively impact the financial trajectory of the product.

Market Expansion

The versatility of ISOVUE-200 in various imaging procedures, including CECT head and body imaging, contributes to its market expansion. As medical imaging technologies advance and the need for precise diagnostics increases, the demand for ISOVUE-200 is expected to grow.

Regulatory Environment

ISOVUE-200 is FDA-approved, which ensures compliance with stringent safety and efficacy standards. The regulatory approval process and ongoing monitoring by regulatory bodies like the FDA are critical for maintaining market confidence and ensuring the product's continued availability[1][3][4].

Manufacturing and Supply Chain

ISOVUE-200 is manufactured by Bracco Diagnostics Inc. at multiple locations, including Germany and Italy. A robust supply chain ensures consistent availability, which is crucial for maintaining market share and financial stability[2].

Patient and Healthcare Provider Preferences

Healthcare providers prefer ISOVUE-200 due to its stability, ease of use, and minimal side effects. Patient safety and comfort are also enhanced by the nonionic nature of the contrast medium, which tends to have fewer adverse reactions compared to ionic contrast agents.

Technological Advancements

Advancements in imaging technologies, such as dynamic computed tomographic imaging, have further enhanced the utility of ISOVUE-200. These technologies allow for better visualization and diagnostic precision, which can drive increased usage and revenue[1][3][4].

Key Takeaways

• Broad Indications: ISOVUE-200 is used in a wide range of diagnostic imaging procedures.
• Cost Efficiency: The ISOVUE Imaging Bulk Package offers significant cost savings and resource efficiency.
• Regulatory Compliance: FDA approval ensures safety and efficacy.
• Market Expansion: Growing demand for precise diagnostics drives market growth.
• Patient and Provider Preferences: Preferred due to stability, ease of use, and minimal side effects.

FAQs

What are the primary indications for ISOVUE-200?

ISOVUE-200 is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography, ventriculography, and intravenous excretory urography, as well as for contrast enhancement in CECT head and body imaging[1][3][4].

How does the ISOVUE Imaging Bulk Package benefit healthcare facilities?

The ISOVUE Imaging Bulk Package improves sustainability, reduces costs associated with contrast waste, and offers a compliant multidose contrast option, allowing for more efficient use of resources[2].

What is the typical cost of ISOVUE-200?

The cost for ISOVUE-200 41% injectable solution can be around $680 for a supply of 2000 milliliters, depending on the pharmacy[5].

Is ISOVUE-200 FDA-approved?

Yes, ISOVUE-200 is FDA-approved, ensuring compliance with stringent safety and efficacy standards[1][3][4].

How is ISOVUE-200 excreted from the body?

ISOVUE-200 is primarily excreted through the kidneys. In patients with normal renal function, the cumulative urinary excretion is approximately 35-40% at 60 minutes and 90% or more in the 72- to 96-hour period after administration[1][3][4].

Sources

1. ISOVUE® (Iopamidol Injection) - accessdata.fda.gov
2. ISOVUE - ISOVUE
3. ISOVUE® (Iopamidol Injection) - accessdata.fda.gov
4. iopamidol injection, solution ISOVUE 200 - DailyMed
5. Isovue-200 Prices, Coupons, Copay Cards & Patient Assistance