AMIPAQUE Drug Patent Profile

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

Amipaque is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in AMIPAQUE is metrizamide. There is one drug master file entry for this compound. Additional details are available on the metrizamide profile page.

Summary for AMIPAQUE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	14
Patent Applications:	3
DailyMed Link:	AMIPAQUE at DailyMed

US Patents and Regulatory Information for AMIPAQUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-003	Sep 12, 1983		DISCN	No	No
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-004	Sep 12, 1983		DISCN	No	No
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for AMIPAQUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-001	Approved Prior to Jan 1, 1982	3,701,771
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-002	Approved Prior to Jan 1, 1982	3,701,771

International Patents for AMIPAQUE

See the table below for patents covering AMIPAQUE around the world.

Country	Patent Number	Title	Estimated Expiration
France	2053037
Canada	935153	2,4,6-TRIIODOBENZOYL AMINES USED AS X-RAY CONTRAST AGENTS
Norway	129093

AMIPAQUE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Amipaque

Introduction

Amipaque, a non-ionic contrast medium, was a significant breakthrough in the field of radiology, particularly in the late 1960s. Developed by Nyegaard & Co., this innovation marked a crucial milestone in Norway's pharmaceutical history. Here, we will delve into the market dynamics and financial trajectory of Amipaque, highlighting its development, market impact, and the economic factors that influenced its success.

Development and Breakthrough

Amipaque was the result of extensive research and development by Nyegaard & Co., particularly by the company's contrast media team. The breakthrough came in 1969, building on the long-term experience with the older product Isopaque and leveraging an international network of researchers and clinicians[5].

Market Entry and Initial Impact

The introduction of Amipaque was a game-changer in radiology. It was the first non-ionic contrast medium that could be safely used in the full spinal canal, the brain's liquid-filled spaces, and the circulatory system. This versatility and safety profile made it an immediate success, filling a niche that larger corporations had not addressed[5].

Market Dynamics

Competitive Landscape

When Amipaque entered the market, it faced limited competition from existing ionic contrast media, which had more severe side effects. Nyegaard & Co.'s strategic focus on a niche use and the input from international experts helped the company to establish a strong market presence quickly. The lack of direct competitors in the non-ionic contrast medium segment allowed Amipaque to capture a significant market share[5].

Pricing Strategy

Given its innovative nature and the lack of direct competition, Amipaque was likely priced at a premium. The value it offered in terms of safety and efficacy justified higher prices, which contributed to its financial success. This pricing strategy is consistent with the economic principles of innovation, where new products with significant value can command higher prices until competition increases[3].

Regulatory Environment

The regulatory environment played a crucial role in the success of Amipaque. The approval process for new medical products is stringent, and Nyegaard & Co.'s ability to navigate this process efficiently was key. Regulatory approvals not only validated the safety and efficacy of Amipaque but also provided a competitive advantage by limiting entry for potential competitors[4].

Financial Trajectory

Initial Revenue and Growth

The financial performance of Amipaque was robust from its inception. The product's unique benefits and the lack of competition led to rapid adoption in the medical community. As a result, Nyegaard & Co. saw significant revenue growth in the early years following the product's launch. This growth was driven by both the increasing number of procedures using Amipaque and the premium pricing strategy[5].

Market Expansion and Penetration

As Amipaque gained acceptance globally, Nyegaard & Co. expanded its market reach. The company's international network and partnerships facilitated this expansion, allowing Amipaque to become a standard in radiology departments worldwide. This market penetration further solidified the product's financial performance and contributed to the company's overall revenue growth[5].

Long-Term Sustainability

The long-term financial sustainability of Amipaque was ensured by its continued innovation and improvement. Nyegaard & Co. continued to invest in research and development, enhancing the product and maintaining its competitive edge. This approach helped Amipaque to remain a market leader even as competition began to emerge in the non-ionic contrast medium segment[5].

Economic Implications

Value Creation

Amipaque created significant value for patients, healthcare providers, and the company itself. The product's safety profile and efficacy reduced the risk of adverse reactions, which in turn reduced healthcare costs associated with complications. For Nyegaard & Co., the value created translated into substantial profits, justifying the high research and development investments[3].

Pricing and Competition

The pricing of Amipaque was influenced by its unique market position and the value it offered. As more non-ionic contrast media entered the market, pricing dynamics changed. However, Amipaque's early mover advantage and continued innovation allowed it to maintain a premium pricing strategy, even in a more competitive environment[4].

Key Takeaways

• Innovation and Market Need: Amipaque's success was driven by its innovative solution to a significant market need, highlighting the importance of addressing unmet medical needs.
• Pricing Strategy: The product's premium pricing was justified by its unique benefits and lack of competition, demonstrating how new products can command higher prices.
• Regulatory Environment: Efficient navigation of the regulatory approval process was crucial for Amipaque's success, emphasizing the role of regulation in pharmaceutical markets.
• Market Expansion: Global market expansion and penetration were key to Amipaque's long-term financial sustainability.
• Continuous Innovation: Ongoing investment in research and development helped maintain Amipaque's competitive edge.

FAQs

1. What made Amipaque a breakthrough in radiology? Amipaque was the first non-ionic contrast medium that could be safely used in the full spinal canal, the brain's liquid-filled spaces, and the circulatory system, offering a significant safety and efficacy advantage over existing ionic contrast media.

2. How did Nyegaard & Co. achieve market success with Amipaque? Nyegaard & Co. achieved market success through a combination of innovative research, strategic focus on a niche use, and leveraging an international network of experts.

3. What was the impact of Amipaque on the financial performance of Nyegaard & Co.? Amipaque significantly boosted Nyegaard & Co.'s revenue and profits due to its rapid adoption, premium pricing, and global market expansion.

4. How did the regulatory environment influence Amipaque's success? The regulatory environment played a crucial role by providing stringent approvals that validated Amipaque's safety and efficacy, thereby limiting competition and enhancing its market position.

5. What strategies did Nyegaard & Co. use to maintain Amipaque's market position over time? Nyegaard & Co. maintained Amipaque's market position through continuous innovation, improving the product, and expanding its global market reach.

Sources

1. Knut Sogner, "Norway's Pharmaceutical Revolution: Pursuing and Accomplishing Innovation in Nyegaard & Co., 1945-1997," Oxford University Press, 2022.
2. "Competition in Prescription Drug Markets, 2017-2022," ASPE, December 2023.
3. "The Economics of Drug Development: Pricing and Innovation in a Changing Market," NBER, October 2018.
4. "Generic Drug Industry Dynamics," Federal Trade Commission, February 2002.
5. "This Is Your Products Liability Restatement on Drugs," BrooklynWorks, accessed December 2023.