ULTRAVIST (PHARMACY BULK) Drug Patent Profile

Which patents cover Ultravist (pharmacy Bulk), and what generic alternatives are available?

Ultravist (pharmacy Bulk) is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in ULTRAVIST (PHARMACY BULK) 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 (PHARMACY BULK)

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	11
Patent Applications:	2,584
DailyMed Link:	ULTRAVIST (PHARMACY BULK) at DailyMed

Recent Clinical Trials for ULTRAVIST (PHARMACY BULK)

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

Sponsor	Phase
Duke Clinical Research Institute	Phase 4
GE Healthcare	Phase 4
Bayer	Phase 4

See all ULTRAVIST (PHARMACY BULK) clinical trials

US Patents and Regulatory Information for ULTRAVIST (PHARMACY BULK)

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 (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-003	Mar 12, 2004		DISCN	Yes	No
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-001	Sep 20, 2002		RX	Yes	Yes
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-002	Sep 20, 2002		RX	Yes	Yes

Expired US Patents for ULTRAVIST (PHARMACY BULK)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-003	Mar 12, 2004
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-001	Sep 20, 2002
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-002	Sep 20, 2002

International Patents for ULTRAVIST (PHARMACY BULK)

See the table below for patents covering ULTRAVIST (PHARMACY BULK) around the world.

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

ULTRAVIST (PHARMACY BULK) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ULTRAVIST (Pharmacy Bulk)

Overview of ULTRAVIST

ULTRAVIST, a brand of iopromide, is an iodine-based contrast agent used in various medical imaging procedures. It is available in different strengths, including 240 mgI/mL, 300 mgI/mL, and 370 mgI/mL, and is utilized for procedures such as computed tomography (CT), angiography, and recently approved for contrast-enhanced mammography (CEM)[2][4][5].

Global Export Market

Export Volume and Growth

From March 2023 to February 2024, the world exported 394 shipments of ULTRAVIST, marking a 4% growth rate compared to the preceding twelve months. However, there was a significant year-on-year decline of 59% in February 2024 compared to February 2023, and a sequential decline 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 include Argentina, India, and Colombia. The product is exported globally to over 65 countries, with detailed information available on over 280 active global buyers[1].

Pricing and Financial Aspects

Export Pricing

The pricing of ULTRAVIST varies based on the strength and volume of the product. For example, a shipment of ULTRAVIST 370 mgI/mL in 100 mL vials can cost around $2,170.62 for 100 units, while a bulk package of ULTRAVIST 300 mgI/mL in 500 mL bottles can cost approximately $48,538.66 for 190 units[1].

Market Trends and Costs

The pharmaceutical market, including contrast agents like ULTRAVIST, is influenced by broader trends such as changes in drug pricing models and the introduction of new treatments. The removal of the Average Manufacturer Price cap (AMP Cap) under the American Rescue Plan Act of 2021 has significant downstream effects on commercial drug pricing, including potential increases in average wholesale prices (AWP) by 13% to 17% annually from 2023 to 2025[3].

Clinical Use and Approval

FDA Approval

ULTRAVIST has recently been approved by the FDA for contrast-enhanced mammography (CEM), making it the only contrast agent indicated for this purpose. This approval expands its use in breast imaging, combining digital mammography with the administration of ULTRAVIST to visualize known or suspected breast lesions[5].

Pharmacokinetics and Pharmacodynamics

ULTRAVIST is characterized by its rapid excretion, with 97% of the dose excreted unchanged in urine within a short period. It is dialyzable and does not undergo significant metabolism. The drug's pharmacokinetics are affected by renal function, with reduced clearance and prolonged half-life in patients with impaired renal function[2].

Adverse Reactions and Safety

Postmarketing Experience

ULTRAVIST has been associated with various adverse reactions, including cardiac disorders, respiratory issues, and skin reactions. These reactions are reported voluntarily, making it challenging to estimate their frequency or establish a causal relationship to drug exposure[4].

Market Expansion and Competitive Landscape

Emerging Modalities

The approval for CEM represents a significant expansion of ULTRAVIST's market, positioning it uniquely in the breast imaging sector. This emerging modality combines digital mammography with contrast agents, enhancing the detection and visualization of breast lesions[5].

Global Buyers and Suppliers

Prominent buyers of ULTRAVIST include companies like BAYER S A, BAYER ZYDUS PHARMA PRIVATE LIMITED, and BAYER DE MEXICO S A DE C V. The use of advanced matching features by platforms like Volza helps identify suitable partners based on billions of shipping invoices and over 20 parameters[1].

Financial Projections and Trends

Commercial Drug Trends

The pharmaceutical industry is experiencing rising costs driven by novel treatments and changes in pricing models. For ULTRAVIST, the financial trajectory will likely be influenced by these broader trends, including potential increases in AWP and shifts in generic dispensing rates. However, as a specialized contrast agent with unique approvals, ULTRAVIST may maintain a strong market position despite these changes[3].

Key Takeaways

• Global Export Growth: ULTRAVIST exports have shown a 4% growth rate over the past year, despite recent declines.
• Pricing Variability: The cost of ULTRAVIST varies significantly based on strength and volume.
• FDA Approval: Recent FDA approval for CEM has expanded ULTRAVIST's clinical use.
• Pharmacokinetics: The drug is characterized by rapid urinary excretion and is dialyzable.
• Adverse Reactions: Various adverse reactions have been reported, highlighting the need for careful patient monitoring.
• Market Expansion: The approval for CEM positions ULTRAVIST uniquely in the breast imaging market.

FAQs

What is ULTRAVIST used for?

ULTRAVIST is an iodine-based contrast agent used in medical imaging procedures such as CT scans, angiography, and recently approved for contrast-enhanced mammography (CEM)[2][5].

Who are the main exporters of ULTRAVIST?

Germany, India, and Turkey are the top exporters of ULTRAVIST[1].

What is the recent FDA approval for ULTRAVIST?

The FDA has approved ULTRAVIST for contrast-enhanced mammography (CEM), making it the only contrast agent indicated for this purpose[5].

How is ULTRAVIST excreted from the body?

ULTRAVIST is primarily excreted unchanged in urine, with 97% of the dose excreted within a short period[2].

What are the potential adverse reactions associated with ULTRAVIST?

ULTRAVIST has been associated with various adverse reactions, including cardiac disorders, respiratory issues, and skin reactions[4].

How does the removal of the AMP Cap affect ULTRAVIST pricing?

The removal of the AMP Cap could lead to increases in average wholesale prices (AWP) and affect the overall financial trajectory of ULTRAVIST and other pharmaceuticals[3].

Sources

1. Volza.com: Ultravist Exports from World - Volza.com
2. FDA: Ultravist - accessdata.fda.gov
3. Milliman: Commercial drug trends: 2024 release - Milliman
4. FDA: ULTRAVIST Imaging Bulk Package - accessdata.fda.gov
5. Biospace: FDA approves Bayer's Ultravist® (iopromide) injection for contrast-enhanced mammography