IOPROMIDE - Generic Drug Details

What are the generic drug sources for iopromide and what is the scope of patent protection?

Iopromide is the generic ingredient in six branded drugs marketed by Bayer Hlthcare and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for iopromide. One supplier is listed for this compound.

Summary for IOPROMIDE

US Patents:	0
Tradenames:	6
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	12
Patent Applications:	4,296
What excipients (inactive ingredients) are in IOPROMIDE?	IOPROMIDE excipients list
DailyMed Link:	IOPROMIDE at DailyMed

Recent Clinical Trials for IOPROMIDE

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

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

See all IOPROMIDE clinical trials

Pharmacology for IOPROMIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for IOPROMIDE

V08AB	Watersoluble, nephrotropic, low osmolar X-ray contrast media
V08A	X-RAY CONTRAST MEDIA, IODINATED
V08	CONTRAST MEDIA
V	Various

US Patents and Regulatory Information for IOPROMIDE

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 300	iopromide	INJECTABLE;INJECTION	020220-002	May 10, 1995		RX	Yes	Yes
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
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-003	Mar 12, 2004		DISCN	Yes	No
Bayer Hlthcare	ULTRAVIST 240	iopromide	INJECTABLE;INJECTION	020220-003	May 10, 1995		DISCN	Yes	No
Bayer Hlthcare	ULTRAVIST 300 IN PLASTIC CONTAINER	iopromide	INJECTABLE;INJECTION	020220-005	Nov 18, 2008		DISCN	Yes	No
Bayer Hlthcare	ULTRAVIST 150	iopromide	INJECTABLE;INJECTION	020220-004	May 10, 1995		DISCN	Yes	No

Expired US Patents for IOPROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ULTRAVIST 370	iopromide	INJECTABLE;INJECTION	020220-001	May 10, 1995
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-003	Mar 12, 2004
Bayer Hlthcare	ULTRAVIST 300	iopromide	INJECTABLE;INJECTION	020220-002	May 10, 1995
Bayer Hlthcare	ULTRAVIST 240	iopromide	INJECTABLE;INJECTION	020220-003	May 10, 1995
Bayer Hlthcare	ULTRAVIST 150	iopromide	INJECTABLE;INJECTION	020220-004	May 10, 1995
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

IOPROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Iopromide

Introduction to Iopromide

Iopromide is a non-ionic, low osmolar iodinated contrast agent used in various radiological diagnostic procedures. It is approved by regulatory bodies such as the FDA and Health Canada under the brand name ULTRAVIST. Iopromide is utilized in procedures like computed tomography (CT), intra-arterial digital subtraction angiography (IA-DSA), cerebral and peripheral arteriography, and more[5].

Market Size and Growth

The global market for iopromide is anticipated to experience significant growth over the coming years. Here are some key metrics:

• Current Market Size: The global iopromide API market was valued at US$ 139 million in 2023[1].
• Forecasted Market Size: It is expected to reach US$ 181.3 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.4% during the forecast period of 2024-2030[1].
• Broader Contrast Media Market: The overall contrast media market, which includes iopromide, is projected to reach USD 6.59 billion by 2029, growing at a CAGR of 7.44% from 2024 to 2029[2].

Key Drivers of Growth

Several factors are driving the growth of the iopromide market:

Increasing Incidence of Chronic Diseases

The rising prevalence of chronic diseases such as cancer, cardiovascular diseases, and other conditions necessitates more diagnostic procedures. For instance, the high prevalence of circulatory diseases and the increasing number of cancer cases globally are expected to drive the demand for contrast media like iopromide[2].

Advancements in Diagnostic Techniques

Advancements in imaging technologies and the increasing use of image-guided procedures are boosting the demand for contrast agents. Iopromide's safety profile, with its non-ionic and low osmolality characteristics, makes it a preferred choice for these procedures[2].

Regulatory Approvals and Product Launches

Recent approvals and launches of generic and branded contrast media agents, such as the FDA approval of Iopromide-300 and -370 (Ultravist) in June 2023, are also driving market growth[2].

Market Segmentation

By Type

The iopromide market is segmented into original drugs and generic drugs. The generic segment is expected to grow as more generic versions of iopromide enter the market, increasing competition and reducing prices[1].

By Application

Iopromide is used in various medical settings, including hospitals and clinics. Its applications range from CT scans and arteriography to excretory urography and phlebography[5].

By Region

The Asia-Pacific region is expected to be one of the fastest-growing markets for contrast media, including iopromide, due to increasing healthcare expenditures and a growing patient population. North America, however, remains the largest market due to high healthcare spending and a high prevalence of chronic diseases[2].

Competitive Landscape

Major Players

The iopromide market is dominated by several key players:

• Bayer: Known for its brand ULTRAVIST.
• Stellite: Another significant player in the iopromide API market.
• Haichang Pharmaceutical: Also a major player in this segment[1].

Strategic Alliances

Strategic alliances and partnerships among key players are crucial for market growth. For example, GE Healthcare's agreement with Sociedad Quimica y Minera de Chile SA to ensure the availability of iodine for X-ray and CT procedures globally is a significant move in this direction[2].

Financial Trajectory

Revenue Forecast

The global iopromide API market is expected to grow from US$ 139 million in 2023 to US$ 181.3 million by 2030, with a CAGR of 4.4% during the forecast period[1].

Pricing Dynamics

The pricing of iopromide and other contrast media is influenced by the number of competitors in the market. As more generic versions enter the market, prices are expected to decline. However, prices remain above long-run marginal costs until there are 8 or more competitors[3].

Regional Market Insights

North America

North America is expected to contribute significantly to the market's growth due to the high prevalence of chronic diseases and increasing healthcare expenditures. The region has seen frequent approvals and launches of new contrast media agents, further driving market growth[2].

Asia-Pacific

The Asia-Pacific region is anticipated to be one of the fastest-growing markets, driven by increasing healthcare spending and a growing patient population.

Challenges and Opportunities

Regulatory Environment

Changes in regulatory policies can impact the market. For instance, increased scrutiny of generic drug applications by the FDA can raise the cost of obtaining approvals, potentially affecting market dynamics[3].

Clinical Advancements

Advancements in the safety and efficacy of iodinated contrast media, such as iopromide, present opportunities for growth. The non-ionic and low osmolality characteristics of iopromide make it a safer option, driving its adoption in various diagnostic procedures[2].

Key Takeaways

• The global iopromide API market is expected to grow at a CAGR of 4.4% from 2024 to 2030.
• The market is driven by increasing chronic disease incidence, advancements in diagnostic techniques, and regulatory approvals.
• Major players include Bayer, Stellite, and Haichang Pharmaceutical.
• The Asia-Pacific region is expected to be a significant growth area, while North America remains the largest market.
• Pricing dynamics are influenced by the number of competitors, with prices declining as more generic versions enter the market.

FAQs

What is the current market size of the global iopromide API market?

The global iopromide API market was valued at US$ 139 million in 2023[1].

What is the forecasted growth rate of the iopromide API market?

The iopromide API market is expected to grow at a CAGR of 4.4% from 2024 to 2030[1].

Who are the major players in the iopromide API market?

The major players include Bayer, Stellite, and Haichang Pharmaceutical[1].

What are the key drivers of the iopromide market?

Key drivers include the increasing incidence of chronic diseases, advancements in diagnostic techniques, and regulatory approvals[2].

How does the number of competitors affect the pricing of iopromide?

Prices decline as more competitors enter the market, but remain above long-run marginal costs until there are 8 or more competitors[3].

Sources

1. Global Iopromide API Market Research Report 2024 - Valuates Reports
2. Contrast Media Market Report: Size, Share, Growth Analysis - Mordor Intelligence
3. Generic Drug Industry Dynamics - Federal Trade Commission
4. Iopromide Market Research Report 2032 - Dataintelo
5. Iopromide: Uses, Interactions, Mechanism of Action - DrugBank Online