ISOVUE-M 200 Drug Patent Profile

When do Isovue-m 200 patents expire, and what generic alternatives are available?

Isovue-m 200 is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in ISOVUE-M 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-m 200

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

Summary for ISOVUE-M 200

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	20
Patent Applications:	3,767
What excipients (inactive ingredients) are in ISOVUE-M 200?	ISOVUE-M 200 excipients list
DailyMed Link:	ISOVUE-M 200 at DailyMed

Recent Clinical Trials for ISOVUE-M 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-M 200 clinical trials

Pharmacology for ISOVUE-M 200

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

US Patents and Regulatory Information for ISOVUE-M 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-M 200	iopamidol	INJECTABLE;INJECTION	018735-001	Dec 31, 1985	AP1	RX	Yes	Yes

Expired US Patents for ISOVUE-M 200

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	ISOVUE-M 200	iopamidol	INJECTABLE;INJECTION	018735-001	Dec 31, 1985	4,001,323

International Patents for ISOVUE-M 200

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

Country	Patent Number	Title	Estimated Expiration
Japan	S5182236	MIZUNIIYOSEINO 2 4 66 TORYOODOOISOFUTARUSANAMIDORUINO SEIHO
Poland	96082
U.S.S.R.	628813	METHOD OF PRODUCING AMIDES OF 5-OXYPROPYLAMINO-2,4,6-TRIIODOISOPHTALIC ACID
Japan	S5642581

ISOVUE-M 200 Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for ISOVUE-M 200

Introduction to ISOVUE-M 200

ISOVUE-M 200, a formulation of iopamidol, is a nonionic radiopaque contrast medium used in various medical imaging procedures. It is manufactured by Bracco Diagnostics Inc. and has been a staple in the diagnostic imaging market for several decades.

Indications and Usage

ISOVUE-M 200 is indicated for intrathecal administration in adult neuroradiology, including myelography (lumbar, thoracic, cervical, and total columnar), and for contrast enhancement of computed tomographic (CECT) cisternography and ventriculography. It is also used for thoraco-lumbar myelography in children over the age of two years[1][3].

Market Segmentation

The market for ISOVUE-M 200 can be segmented based on the type of procedure, patient demographics, and geographical regions.

Procedure-Based Segmentation

• Myelography: This is a significant segment, especially for diagnosing spinal cord and nerve root disorders.
• Computed Tomographic Imaging: ISOVUE-M 200 is used to enhance CT imaging of the head and body, particularly in areas that are difficult to visualize.
• Angiography: Although ISOVUE-M 200 is not primarily used for angiography, its formulations are used in various vascular procedures[2][3].

Patient Demographics

• Adults: The primary user group for ISOVUE-M 200 in neuroradiology.
• Pediatrics: Used for thoraco-lumbar myelography in children over two years old.

Geographical Segmentation

• Global Presence: ISOVUE-M 200 is available in multiple countries, with manufacturing sites in Germany, Italy, and the USA[1].

Competitive Landscape

The contrast media market is competitive, with several other nonionic contrast agents available.

Key Competitors

• Omnipaque (iohexol): Another widely used nonionic contrast medium.
• Gadavist (gadobutrol): Used for MRI contrast enhancement but also competes in the broader diagnostic imaging market.
• Generic Alternatives: With the approval of generic versions of iopamidol, competition from generic manufacturers like Hainan Poly is increasing[4].

Financial Performance

Revenue Trends

• ISOVUE-M 200 has been a consistent revenue generator for Bracco Diagnostics Inc. due to its wide range of indications and established market presence.
• The revenue is influenced by the volume of procedures, pricing strategies, and competition from generic alternatives.

Pricing Strategies

• The pricing of ISOVUE-M 200 is competitive, with considerations for the cost of production, regulatory approvals, and market demand.
• Generic versions may offer lower pricing, which could impact the market share of the branded product[4].

Regulatory Environment

FDA Approvals

• ISOVUE-M 200 was approved by the FDA in 1987, with subsequent approvals for different formulations and strengths[4].

Safety and Efficacy

• The product is subject to strict regulatory oversight, with ongoing monitoring for safety and efficacy. Adverse reactions and drug interactions are closely tracked[1][2].

Safety and Adverse Reactions

Common Adverse Reactions

• Headache, nausea, vomiting, and musculoskeletal pain are among the most frequent adverse reactions reported[1][2].

Contraindications

• Intrathecal administration of corticosteroids with iopamidol is contraindicated. Myelography should not be performed in the presence of significant local or systemic infection[1].

Pharmacokinetics and Excretion

Elimination Half-Life

• The elimination half-life of iopamidol is approximately two hours in normal subjects, with no significant metabolism or biotransformation occurring. It is primarily excreted through the kidneys[2].

Generic Availability

Impact on Market Dynamics

• The approval of generic versions of iopamidol has introduced competition, potentially affecting the market share and pricing of ISOVUE-M 200. Generic alternatives may attract price-sensitive customers, especially in regions with stringent healthcare budgets[4].

Manufacturing and Supply Chain

Manufacturing Sites

• ISOVUE-M 200 is manufactured at multiple sites, including BIPSO GmbH in Germany, Patheon Italia S.p.A. in Italy, and S. M. Farmaceutici SRL in Italy[1].

Market Growth Prospects

Increasing Demand for Diagnostic Imaging

• The demand for diagnostic imaging procedures is increasing due to an aging population and the need for early disease detection. This trend is expected to drive the market for contrast media like ISOVUE-M 200.

Technological Advancements

• Advances in imaging technologies, such as improved CT and MRI machines, may enhance the utility and demand for contrast agents like ISOVUE-M 200.

Challenges and Opportunities

Competition from New Technologies

• Emerging technologies in diagnostic imaging, such as contrast-free imaging techniques, could pose a challenge to traditional contrast agents.
• Personalized Medicine: The trend towards personalized medicine may create opportunities for tailored contrast agents, although this is still in the early stages of development.

Key Takeaways

• Established Market Presence: ISOVUE-M 200 has a strong market presence due to its wide range of indications and long history of use.
• Competitive Landscape: The market is competitive, with both branded and generic alternatives available.
• Regulatory Compliance: Strict regulatory oversight ensures safety and efficacy.
• Growing Demand: Increasing demand for diagnostic imaging procedures is expected to drive market growth.
• Technological Advancements: Advances in imaging technologies may enhance the utility of ISOVUE-M 200.

FAQs

1. What are the primary indications for ISOVUE-M 200?

   • ISOVUE-M 200 is indicated for intrathecal administration in adult neuroradiology, including myelography and contrast enhancement of computed tomographic (CECT) cisternography and ventriculography[1].

2. Can ISOVUE-M 200 be used in pediatric patients?

   • Yes, ISOVUE-M 200 is used for thoraco-lumbar myelography in children over the age of two years[1].

3. What are the common adverse reactions associated with ISOVUE-M 200?

   • Common adverse reactions include headache, nausea, vomiting, and musculoskeletal pain[1][2].

4. Is ISOVUE-M 200 available in generic form?

   • Yes, generic versions of iopamidol have been approved and are available in the market[4].

5. How is ISOVUE-M 200 excreted from the body?

   • ISOVUE-M 200 is primarily excreted through the kidneys, with an elimination half-life of approximately two hours in normal subjects[2].

Cited Sources

1. Bracco Diagnostics Inc. - ISOVUE-M® 200, 300 (Iopamidol Injection) INDICATION[1].
2. Drugs.com - Isovue: Package Insert / Prescribing Information[2].
3. RxList - Isovue-M (Iopamidol Injection): Side Effects, Uses, Dosage[3].
4. Drugs.com - Generic Isovue-200 Availability[4].