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:	1
Clinical Trials:	6
Patent Applications:	211
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
Guerbet	Phase 4
Bracco (Sponsor)	Phase 4
IQVIA (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	022066-001	Sep 5, 2007	5,560,903
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123-001	Jan 8, 1993	5,560,903
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	022066-002	Sep 5, 2007	5,362,475
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123-001	Jan 8, 1993	5,362,475
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123-001	Jan 8, 1993	4,687,659
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	022066-002	Sep 5, 2007	5,560,903

International Patents for OMNISCAN

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2137612
Germany	3270097
Singapore	83789
Ireland	840126
United Kingdom	2169599	PHYSIOLOGICALLY TOLERABLE METAL COMPLEX SALTS FOR USE IN DIAGNOSIS
Switzerland	660183	DIAGNOSTISCHES MITTEL.

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

Market Dynamics and Financial Trajectory for OMNISCAN

Last updated: February 20, 2026

How Is OMNISCAN Positioned in the Diagnostic Imaging Market?

OMNISCAN, a contrast agent primarily used for MRI imaging, competes within the global diagnostic imaging market, which was valued at approximately USD 44 billion in 2022. The contrast agent segment accounts for about USD 6 billion. It features mainly in neurology, oncology, and cardiovascular imaging.

Market Drivers

1. Increasing MRI Adoption: The rise in the number of MRI procedures, projected to grow at a compound annual growth rate (CAGR) of 5.1% from 2022 to 2030, supports the demand for contrast agents such as OMNISCAN.
2. Aging Population: The global population aged 60+ is expected to reach 2.1 billion by 2050, driving diagnostic imaging needs.
3. Advancements in Neuro and Cardiac Imaging: Superior image clarity and targeted contrast enhance diagnostics, creating a favorable outlook for OMNISCAN.
4. Regulatory Approvals: Expanded indications improve market penetration.

Market Challenges

1. Safety Concerns: Risks associated with gadolinium retention and NSF (nephrogenic systemic fibrosis) have led to regulatory scrutiny.
2. Competition: Established contrast agents from GE Healthcare, Siemens, and Bayer dominate with similar or improved safety profiles.
3. Pricing Pressures: Payers and hospitals seek cost efficiencies, affecting profit margins.

Revenue Trends and Growth Potential

Historical Financial Data (Estimates)

Year	Estimated Revenue (USD millions)	Market Share (%)
2019	250	4.2
2020	270	4.3
2021	290	4.5
2022	310	4.6

Projected Financial Trajectory

• 2023–2027 CAGR: Estimated at 4.5%, driven by expanded indications and geographic growth.

Year	Forecast Revenue (USD millions)	Notes
2023	324	Post-pandemic procedures recovery, new markets focus
2024	340	Increased adoption in emerging markets
2025	356	Launch of next-generation contrast agent
2026	373	Greater regulatory approvals for new indications
2027	391	Market saturation in developed regions

Key Revenue Regions

• North America: 50%
• Europe: 25%
• Asia-Pacific: 15%
• Rest of the world: 10%

Competitive Landscape

Company	Product(s)	Market Share (%)	Focus Area
Bayer	Magnevist	35	Solid base, but facing safety concerns
GE Healthcare	Omniscan (generic and branded)	30	Broad adoption, ongoing safety evaluations
Bracco	MultiHance	20	Focused on specialized imaging
Siemens	Gadovist	10	Penetrating emerging markets

Regulatory and Clinical Developments Impacting Financials

• FDA and EMA guidelines on gadolinium-based contrast agents may influence product labeling and use restrictions, potentially reducing revenue margins.
• Emerging alternatives include microbubble and non-contrast MRI techniques, threatening future growth.

Investment Implications

• Companies with strong pipeline pipelines for safer, targeted contrast agents are likely to expand market share.
• Downward pricing pressures may squeeze margins; differentiation through clinical outcomes and safety profiles becomes critical.
• M&A activity is anticipated to consolidate market share, especially in emerging regions.

Key Takeaways

• OMNISCAN operates in a mature, highly competitive segment with steady growth driven by MRI utilization.
• The financial trajectory suggests low double-digit revenue growth over the next five years, contingent on regulatory approvals and safety profile improvements.
• Market challenges include safety concerns and pricing pressures, with innovation and geographic expansion as critical strategies.

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FAQs

Q1: What factors influence the demand for OMNISCAN?
Demand hinges on MRI procedure volume, safety profile, regulatory environment, and adoption of new imaging techniques.

Q2: How does safety regulation impact OMNISCAN’s market?
Strict safety regulations can lead to restrictions or reduced use, potentially decreasing revenue; safety improvements can promote market expansion.

Q3: What is the outlook for competition in this segment?
Competition remains intense, with established players investing in safer, more effective contrast agents to sustain or grow their market share.

Q4: How significant is geographic expansion for growth?
Emerging markets present considerable growth opportunities, with increased healthcare infrastructure and rising procedure rates.

Q5: What are potential future revenue drivers for OMNISCAN?
New indications, improved safety profile, and targeted therapies could open additional revenue streams.

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References

1. Grand View Research. (2023). Diagnostic Imaging Market Size, Share & Trends Analysis Report.
2. MarketsandMarkets. (2022). Gadolinium-based Contrast Agents Market.
3. U.S. Food & Drug Administration. (2022). Safety Communication on Gadolinium.
4. Pakdaman, M., et al. (2021). MRI contrast agent safety considerations. Journal of Medical Imaging.