OMNISCAN Drug Patent Profile

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

Omniscan is a drug marketed by Ge Healthcare and is included in two NDAs.

The generic ingredient in OMNISCAN is gadodiamide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gadodiamide profile page.

Summary for OMNISCAN

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	6
Patent Applications:	1,376
Drug Prices:	Drug price information for OMNISCAN
What excipients (inactive ingredients) are in OMNISCAN?	OMNISCAN excipients list
DailyMed Link:	OMNISCAN at DailyMed

See drug prices for OMNISCAN

Recent Clinical Trials for OMNISCAN

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

Sponsor	Phase
IQVIA (Sponsor)	Phase 4
Bayer AG (Sponsor)	Phase 4
GEHC (Sponsor)	Phase 4

See all OMNISCAN clinical trials

Pharmacology for OMNISCAN

Drug Class	Paramagnetic Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity

US Patents and Regulatory Information for OMNISCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	022066-001	Sep 5, 2007		DISCN	Yes	No
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	022066-002	Sep 5, 2007		DISCN	Yes	No
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123-001	Jan 8, 1993		RX	Yes	Yes

Expired US Patents for OMNISCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123-001	Jan 8, 1993
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	022066-001	Sep 5, 2007
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123-001	Jan 8, 1993
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123-001	Jan 8, 1993
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	022066-002	Sep 5, 2007
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	022066-002	Sep 5, 2007

International Patents for OMNISCAN

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

Country	Patent Number	Title	Estimated Expiration
Canada	1240679	SELS COMPLEXES PARAMAGNETIQUES, PROCEDE DE PREPARATION ET UTILISATION DANS LES DIAGNOSTICS PAR RMN (PARAMAGNETIC COMPLEX SALTS, THEIR PREPARATION, AND THEIR USE IN NMR-DIAGNOSTICS)
South Africa	8205313
New Zealand	219079	METAL COMPLEX SALTS AND DIAGNOSTIC PREPARATIONS FOR USE IN NMR DIAGNOSIS
Japan	S5829718	DRUG FOR AFFECTING ALLIVIATION TIME ON NMR-DIAGNOSIS, MANUFACTURE AND PHYSIOLOGICALLY ACCEPTABLE COMPLEX SALT
Japan	2556627
Singapore	83689
Japan	H0768193

Supplementary Protection Certificates for OMNISCAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0071564	SPC/GB93/060	United Kingdom
0216511	94C0015	Belgium		PRODUCT NAME: GADODIAMIDE; NAT. REGISTRATION NO/DATE: NL 19253 19940425; FIRST REGISTRATION: GB - 0637/0015 19920925

OMNISCAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Omniscan

Introduction

Omniscan, also known as gadodiamide, is a gadolinium-based contrast agent (GBCA) widely used in magnetic resonance imaging (MRI) to detect and visualize lesions. Understanding the market dynamics and financial trajectory of Omniscan is crucial for stakeholders, including manufacturers, healthcare providers, and investors.

Market Overview

Usage and Applications

Omniscan is utilized in contrasted MRI procedures to enhance the visibility of internal body structures. It is particularly useful in diagnosing conditions such as tumors, vascular diseases, and inflammatory diseases[4].

Competitive Landscape

The market for GBCAs is competitive, with several other agents available, including both linear and macrocyclic types. Omniscan, being a linear GBCA, faces competition from macrocyclic agents like ProHance, which are often considered safer due to lower gadolinium retention in the body[1].

Safety and Regulatory Considerations

Biological Effects and Safety Concerns

Recent studies have highlighted the differences in safety profiles between linear and macrocyclic GBCAs. Omniscan has been shown to cause significant perturbations in the metabolic homeostasis of mice, particularly affecting the brain, cerebellum, and liver. This is in contrast to macrocyclic agents like ProHance, which do not significantly alter the metabolome[1].

Regulatory Implications

The safety concerns associated with Omniscan could lead to stricter regulatory oversight. Manufacturers may need to invest in research and development to create safer alternatives or to mitigate the adverse effects of existing agents. This could impact the market share and financial performance of Omniscan.

Financial Performance

Pricing and Revenue

Omniscan is priced competitively in the market. For instance, the cost per milliliter of Omniscan solution can range from $6.49 to $7.02 USD, depending on the packaging and supplier[4].

Market Share and Sales

Despite the safety concerns, Omniscan remains a widely used GBCA due to its established presence in the market. However, the growing preference for macrocyclic agents could erode its market share over time.

Manufacturer Strategies

GE Healthcare

GE Healthcare, one of the primary manufacturers of Omniscan, has been focusing on corporate transformation and strategic investments. While the company has achieved growth in its medical business, it must navigate the challenges posed by the safety profile of Omniscan. This might involve investing in R&D to develop safer GBCAs or diversifying its product portfolio[2].

Impact of Research and Development

Development of New GBCAs

Research aimed at developing new GBCAs with lower general toxicity is ongoing. This could lead to the introduction of new products that might replace or complement Omniscan in the market. Such developments are crucial for maintaining market relevance and addressing safety concerns[1].

Market Trends and Future Outlook

Shifts in Consumer Preferences

Healthcare providers and patients are increasingly aware of the safety differences between linear and macrocyclic GBCAs. This awareness is likely to drive a shift towards safer alternatives, potentially reducing the demand for Omniscan.

Economic Factors

The financial performance of Omniscan will also be influenced by broader economic factors, such as healthcare spending and the availability of alternative diagnostic tools. Early diagnosis and minimally invasive treatments, which are areas where GBCAs are crucial, are expected to continue growing, but the specific demand for Omniscan may decline[2].

Key Takeaways

• Safety Concerns: Omniscan's safety profile, particularly its higher gadolinium retention, is a significant concern that could impact its market share.
• Regulatory Oversight: Stricter regulations may force manufacturers to invest in safer alternatives.
• Market Competition: The preference for macrocyclic GBCAs is increasing, posing a competitive threat to Omniscan.
• Financial Performance: Pricing and revenue are influenced by market share, regulatory environment, and consumer preferences.
• Research and Development: Ongoing research to develop safer GBCAs is critical for the long-term viability of the product.

FAQs

What is Omniscan used for?

Omniscan, or gadodiamide, is used as a contrast agent in MRI procedures to detect and visualize lesions within the body.

What are the safety concerns associated with Omniscan?

Omniscan has been shown to cause significant metabolic perturbations, particularly affecting the brain, cerebellum, and liver, due to higher gadolinium retention compared to macrocyclic agents.

How does Omniscan compare to other GBCAs?

Omniscan is a linear GBCA, which generally has a higher risk of gadolinium retention compared to macrocyclic agents like ProHance.

What is the impact of regulatory oversight on Omniscan?

Stricter regulations could force manufacturers to invest in safer alternatives, potentially reducing the market share of Omniscan.

What are the future prospects for Omniscan in the market?

The future prospects for Omniscan are uncertain due to growing safety concerns and the increasing preference for macrocyclic GBCAs. Manufacturers may need to develop safer alternatives to maintain market relevance.

Sources

1. Comparison of the biological effects of gadodiamide (Omniscan) and gadoteridol (ProHance) in healthy mice. RSC Advances, 2023.
2. Integrated Report 2021. Olympus Global, 2021.
3. Shifting drug markets in North America - a global crisis in the making? PubMed, 2023.
4. Gadodiamide: Uses, Interactions, Mechanism of Action. DrugBank.
5. Convocation Notice of the 9th Ordinary General Meeting of Shareholders. Daiichi Sankyo, 2014.