ULTRAVIST 370 Drug Patent Profile

Which patents cover Ultravist 370, and when can generic versions of Ultravist 370 launch?

Ultravist 370 is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in ULTRAVIST 370 is iopromide. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the iopromide profile page.

Summary for ULTRAVIST 370

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	11
Patent Applications:	2,584
DailyMed Link:	ULTRAVIST 370 at DailyMed

Recent Clinical Trials for ULTRAVIST 370

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

Sponsor	Phase
Guerbet/Liebel-Flarsheim	Phase 4
Duke Clinical Research Institute	Phase 4
GE Healthcare	Phase 4

See all ULTRAVIST 370 clinical trials

Pharmacology for ULTRAVIST 370

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

US Patents and Regulatory Information for ULTRAVIST 370

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	ULTRAVIST 370	iopromide	INJECTABLE;INJECTION	020220-001	May 10, 1995		RX	Yes	Yes

Expired US Patents for ULTRAVIST 370

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ULTRAVIST 370	iopromide	INJECTABLE;INJECTION	020220-001	May 10, 1995	4,364,921

International Patents for ULTRAVIST 370

See the table below for patents covering ULTRAVIST 370 around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	2909439
Yugoslavia	61780
Spain	491254
South Africa	8001350

ULTRAVIST 370 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ULTRAVIST 370

Overview of ULTRAVIST 370

ULTRAVIST 370, an iodinated contrast agent, is widely used in medical imaging procedures such as computed tomography (CT) scans, angiography, and other radiologic examinations. It is manufactured by Bayer AG, a global pharmaceutical and life sciences company.

Global Export Trends

Export Volume and Growth

From March 2023 to February 2024, the global exports of ULTRAVIST saw a total of 394 shipments, marking a 4% growth rate compared to the preceding twelve months. However, in February 2024 alone, there was a significant decline with 15 export shipments, representing a year-on-year decrease of 59% and a sequential decrease of 48% from January 2024[1].

Key Exporters and Importers

Germany leads the world in ULTRAVIST exports, followed by India and Turkey. The primary importers of ULTRAVIST are Argentina, India, and Colombia. This distribution highlights the global demand for this contrast agent, particularly in regions with growing healthcare needs[1].

Market Dynamics

Regional Sales Performance

The sales performance of ULTRAVIST varies by region. For instance, while Bayer's overall sales in the Asia/Pacific region have seen fluctuations, the demand for contrast agents like ULTRAVIST remains steady due to the increasing need for diagnostic imaging in these markets[2].

Competitive Landscape

ULTRAVIST competes with other iodinated contrast agents such as iohexol and iopamidol. Clinical trials have shown that ULTRAVIST provides comparable or superior visualization ratings in various radiologic procedures, which helps maintain its market position[5].

Financial Performance

Revenue and Sales

Bayer's financial reports indicate that the company's pharmaceutical segment, which includes ULTRAVIST, has experienced mixed results. While the overall sales for Bayer's pharmaceutical division have shown growth, the specific revenue from ULTRAVIST is influenced by factors such as pricing, volume, and regional demand. For example, in the third quarter of 2024, Bayer reported a decline in sales in some regions, partly due to currency fluctuations and portfolio adjustments[2].

Profit Margins and EBITDA

The EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization) for Bayer's pharmaceutical segment has seen fluctuations. In the third quarter of 2024, the EBITDA margin before special items was 24.3%, indicating the segment's profitability despite challenges. The financial performance of ULTRAVIST specifically would be a subset of these broader pharmaceutical segment metrics[2].

Pricing and Cost Analysis

Export Pricing

The export prices of ULTRAVIST vary based on the volume and presentation of the product. For instance, shipments of ULTRAVIST 370 in 100ml vials have been priced around $2,170 per 100 units, while larger volumes such as 500ml presentations are priced differently, reflecting economies of scale[1].

Production and Distribution Costs

Bayer's overall research and development expenses, as well as capital expenditures, impact the pricing strategy for ULTRAVIST. In 2024, Bayer reported increased research and development expenses, which could influence the production costs and subsequently the pricing of ULTRAVIST[2].

Clinical and Diagnostic Use

Pharmacokinetics and Pharmacodynamics

ULTRAVIST 370 is characterized by its rapid peak iodine plasma levels immediately following intravenous injection, with levels falling within 5 to 10 minutes due to dilution in vascular and extravascular fluid compartments. This pharmacokinetic profile makes it effective for various diagnostic procedures[5].

Clinical Trials and Efficacy

Clinical trials have demonstrated that ULTRAVIST 370 provides excellent visualization ratings in procedures such as coronary arteriography, left ventriculography, and aortography. These trials have shown that ULTRAVIST is comparable to or sometimes superior to other contrast agents like iohexol and iopamidol[5].

Future Outlook

Market Growth Potential

The demand for diagnostic imaging is expected to grow, driven by increasing healthcare needs and advancements in medical technology. This trend suggests a positive outlook for ULTRAVIST 370, especially in emerging markets where access to advanced diagnostic tools is expanding.

Regulatory and Competitive Factors

The future financial trajectory of ULTRAVIST will also be influenced by regulatory changes, competitive dynamics, and the introduction of new contrast agents. Bayer's strategic focus on innovation and portfolio management will be crucial in maintaining ULTRAVIST's market position.

Key Takeaways

• Global Export Trends: ULTRAVIST exports have shown a mixed performance, with overall growth but significant monthly fluctuations.
• Market Dynamics: The product competes with other iodinated contrast agents and maintains its market position through clinical efficacy.
• Financial Performance: The financial metrics for ULTRAVIST are part of Bayer's broader pharmaceutical segment, showing mixed results due to various market and economic factors.
• Pricing and Cost Analysis: Pricing varies by volume and presentation, influenced by production and distribution costs.
• Clinical and Diagnostic Use: ULTRAVIST 370 is effective in various diagnostic procedures due to its pharmacokinetic profile.

FAQs

What are the primary regions for ULTRAVIST exports?

The primary regions for ULTRAVIST exports are Argentina, India, and Colombia, with Germany, India, and Turkey being the top exporters[1].

How does ULTRAVIST 370 compare to other contrast agents?

ULTRAVIST 370 has been shown to provide comparable or superior visualization ratings to other iodinated contrast agents like iohexol and iopamidol in clinical trials[5].

What factors influence the pricing of ULTRAVIST 370?

The pricing of ULTRAVIST 370 is influenced by factors such as volume, presentation, production costs, and distribution expenses[1].

What is the pharmacokinetic profile of ULTRAVIST 370?

ULTRAVIST 370 has rapid peak iodine plasma levels immediately following intravenous injection, with levels falling within 5 to 10 minutes due to dilution in vascular and extravascular fluid compartments[5].

How does Bayer's overall financial performance impact ULTRAVIST 370?

Bayer's overall financial performance, including sales, EBITDA, and research and development expenses, influences the financial trajectory and pricing strategy for ULTRAVIST 370[2].

Sources

1. Volza.com: Ultravist Exports from World - Volza.com
2. Bayer AG: Quarterly Statement Third Quarter of 2024 - Bayer AG
3. AnnualReports.com: Science For A Better Life - Bayer Annual Report 2006
4. PharmaCompass.com: Ultravist 370 - PharmaCompass.com
5. FDA: ULTRAVIST - accessdata.fda.gov