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:	1,720
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
GEHC (Sponsor)	Phase 4
Guerbet	Phase 4
Bracco (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	022066-002	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

International Patents for OMNISCAN

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

Country	Patent Number	Title	Estimated Expiration
Germany	3590496
Germany	3590578	Paramagnetische Diamid-DTPA-Kontrastmittel für MR-Tomographie
European Patent Office	0200750	DIESTER-DTPA-PARAMAGNETIC CONTRAST AGENTS FOR MRI IMAGING, APPARATUS AND METHODS
European Patent Office	0203962	DIAMIDE-DTPA-PARAMAGNETIC CONTRAST AGENTS FOR MR IMAGING, APPARATUS AND METHODS
United Kingdom	2177086	DIESTER-DTPA-PARAMAGNETIC CONTRAST AGENTS FOR MRI IMAGING, APPARATUS AND METHODS

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 (gadoteridol) market dynamics and financial trajectory: exclusivity, competition, contracting trends, and revenue exposure

Last updated: July 30, 2026

OMNISCAN (gadoteridol) is a gadolinium-based contrast agent (GBCA) used in MRI. Commercial dynamics are shaped by (1) GBCA class-wide utilization linked to imaging volumes, (2) product-level formulary access and group purchasing organization (GPO) contracting, and (3) regulatory and safety-driven substitution dynamics across GBCAs. Financial trajectory is primarily determined by long-run MRI demand, competitive positioning among other macrocyclic GBCAs, and share shifts tied to price and contracting.

Which market dynamics drive OMNISCAN revenue growth or decline?

OMNISCAN is sold as a GBCA for MRI contrast enhancement. The revenue line moves with four interlocking forces: procedure volume, payer and provider contracting, GBCA safety and label-driven usage patterns, and supply continuity.

What role does MRI procedure volume play?

GBCA revenue is a function of MRI utilization (outpatient and hospital), protocol intensity (contrast use rates), and dose per procedure. In practice, OMNISCAN share responds to imaging growth more than to any on-label expansion, because GBCA indications are typically stable and address diagnostic enhancement rather than new disease categories.

How do formularies and GPO contracts affect OMNISCAN?

GBCA products are routinely standardized through health-system formularies and GPO pricing. Those mechanisms typically produce:

• Preferential placement for a small subset of GBCAs, often favoring macrocyclic agents.
• Aggressive annual contract renewals that shift share between competitors based on net price.
• Rebate and bundling strategies that can reduce realized margins even when list prices hold.

How do GBCA safety and substitution patterns influence OMNISCAN?

The GBCA market has shifted materially toward macrocyclic agents and away from linear agents after regulatory actions and risk communication around gadolinium retention. OMNISCAN is gadoteridol, a macrocyclic GBCA, which supports baseline competitiveness versus linear agents. Within the macrocyclic class, substitution is usually driven by contracting and procurement economics rather than new clinical differentiation.

What supply and manufacturing continuity risks matter?

GBCA manufacturing is sensitive to sterile fill-finish capacity and quality controls. Any supply interruption can produce temporary share loss even if the product remains the preferred contract option.

How has OMNISCAN performed financially: pricing, demand, and share trajectory?

Publicly available, high-resolution revenue-by-year metrics for OMNISCAN are typically limited. GBCA brands with niche differentiation often do not publish full standalone financials at the brand level; results are more commonly embedded in corporate segment disclosures. As a result, the best business-grade readout is indirect: market contracting shifts, utilization trends for MRI contrast agents, and share movement within the macrocyclic GBCA basket.

What financial signals track GBCA brand trajectory in practice?

For OMNISCAN, monitoring should focus on:

• Net pricing and contract outcomes with large hospital systems and radiology groups.
• Mix effects tied to outpatient imaging growth, higher MRI volume, and protocol changes.
• Competitive substitution into preferred macrocyclic alternatives based on net cost.
• Inventory and supply stability during periods of manufacturing constraints across the class.

How does the macrocyclic GBCA basket affect OMNISCAN margins?

Macrocyclic GBCA products often compete on net price under tendering. This compresses margins and pushes revenue growth toward volume rather than pricing. When imaging volume grows, branded macrocyclic agents can maintain revenue; when volume plateaus, price concessions decide the winner.

What is the competitive landscape for OMNISCAN and where is price pressure coming from?

OMNISCAN competes with other GBCA products used for MRI enhancement. Competition is usually across the macrocyclic GBCA subset and depends on:

• Hospital formulary status
• GPO contract placement
• Rebate structures
• Tender-driven procurement
• Supply continuity

Which substitutes most directly pressure OMNISCAN?

The most direct competitive substitutes are other macrocyclic GBCAs. In a contracting environment, the “lowest net cost per MRI exam” typically wins, all else equal.

How do competitors use tendering and contracting?

Competitors often pursue:

• Multi-year GPO commitments with escalators tied to volume thresholds
• Contract revisions after annual price reviews
• Pharmacy benefit manager or hospital pharmacy tendering strategies
• Promotional incentives targeted at radiology purchasing committees

When does OMNISCAN face generic or biosimilar-style entry risks?

For small-molecule drugs like gadoteridol, there is no biosimilar framework. The entry risk is generic, typically driven by:

• Patent expiration and the availability of ANDA pathways (for traditional small molecules)
• Exclusivity periods under FDA Orange Book listings
• Patent litigation outcomes that determine launch timing

What patent and exclusivity factors determine generic launch timing?

Generic risk for OMNISCAN depends on the Orange Book patent estate and any unexpired exclusivities listed for gadoteridol products. Launch timing is further constrained by:

• Court injunctions or settlements following Paragraph IV challenges
• Switching and contracting friction: even if a generic is approved, adoption can lag due to formulary processes and quality system validation

What is the Orange Book status of OMNISCAN and what patents protect it?

The Orange Book status is the decisive source for:

• Listed drug substance and drug product patents
• Approval and exclusivity codes
• Expiration dates tied to patent terms and exclusivity windows

How many patents are listed for OMNISCAN?

A reliable patent count and expiry timetable must be pulled from the FDA Orange Book listing for OMNISCAN/gadoteridol by strength and dosage form. Without a listing-specific patent table, it is not possible to produce an accurate “how many patents” figure or a defensible expiry schedule.

What formulation and method-of-use IP could block substitution?

For GBCA products, the practical blockers are typically:

• Drug product formulation and composition patents
• Manufacturing process or sterile fill-related patents
• Indication-specific method-of-use patents (less common for GBCA exposure patterns, but possible)

What patent litigation or settlement activity has shaped OMNISCAN market entry?

Patent litigation shapes GBCA competition primarily through:

• Paragraph IV filings and court outcomes
• “Design-around” product changes (concentration, container closure, or excipients) that preserve patent position
• Settlement agreements that impose delayed launches or noninfringement covenants

How do settlements affect revenue trajectory?

Even when a generic enters late, settlements can extend the incumbent’s net pricing power through:

• Contract retention before generics are approved for tendering
• Continued procurement of the incumbent during the litigation hold period

How does FDA regulatory status affect OMNISCAN demand and payer coverage?

FDA regulatory status influences demand through:

• Ongoing safety communications that change prescribing behavior
• Label updates that affect clinical protocols
• Distribution continuity and product availability

What FDA milestones matter for GBCA brands?

For market dynamics, the relevant milestones are:

• Initial NDA approvals and any supplement approvals
• Label revisions tied to safety communications on gadolinium retention
• Postmarketing requirements that affect supply or manufacturing operations

What gross-to-net and contracting economics determine OMNISCAN profitability?

GBCA brands typically face:

• High rebate pressure and tender-driven net pricing
• Margin sensitivity to annual contract renegotiations
• Cost of goods volatility tied to sterile packaging and manufacturing yields

What drives OMNISCAN net price down?

Net price decreases are usually caused by:

• Winning competitor tenders based on price and service levels
• Increased purchasing leverage from large hospital groups
• PBM-style contracting structures when applicable

What offsets net price compression?

Potential offsets include:

• Contract wins at favorable pricing tiers
• Supply reliability that prevents switches away from the incumbent
• Preferred formulary placement within macrocyclic-only protocols

What generic entry scenarios could change OMNISCAN market share?

Generic share shifts in GBCAs often follow a pattern: approval is followed by formulary evaluation, then limited adoption, then expansion as quality and supply validation completes.

Scenario framing for market impact

• Early adoption scenario: Generic approved with no major formulary friction, leading to rapid share loss.
• Delayed adoption scenario: Contracting lags and incumbent retains volume, limiting generic impact in the first 12 to 24 months.
• Limited adoption scenario: Generic launches but does not win preferred tender placement due to net price or service terms.

Key Takeaways

• OMNISCAN revenue is driven more by MRI utilization, contrast use rates, and contracting outcomes than by major clinical changes.
• Competitive pressure is primarily within the macrocyclic GBCA class and is contract-driven, producing net price compression risk.
• Patent and FDA Orange Book status determine generic entry timing, but a defensible patent-by-patent expiry schedule requires Orange Book listing data by strength and dosage form.
• Litigation and settlements can extend the incumbent’s share and net pricing power, with adoption friction often delaying generic market share erosion.

FAQs

1. How do macrocyclic GBCA contracting trends determine OMNISCAN formulary status?
2. What drives net price changes for gadoteridol across large hospital systems and radiology groups?
3. What patent-expiration mechanics most affect generic entry for gadoteridol products?
4. How does MRI procedure growth versus contrast utilization rate change OMNISCAN’s revenue exposure?
5. What supply continuity factors influence GBCA brand share stability during manufacturing disruptions?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (FDA database).
2. U.S. Food and Drug Administration. FDA Drug Safety Communications related to gadolinium-based contrast agents and gadolinium retention (FDA website).
3. FDA. Prescribing Information for OMNISCAN (gadoteridol) (FDA label repository).