Last updated: August 12, 2026
OptiMARK in Plastic Container is gadoversetamide injection, a gadolinium-based contrast agent used for magnetic resonance imaging. Its commercial trajectory is that of a mature, low-growth product displaced by newer macrocyclic agents and affected by regulatory scrutiny over gadolinium retention and nephrogenic systemic fibrosis. FDA records identify OptiMARK as a discontinued product, and public filings do not report product-level revenue. The plastic-container presentation is a packaging configuration, not a separate active pharmaceutical ingredient or a distinct therapeutic product.
What is OptiMARK in Plastic Container?
OptiMARK contains gadoversetamide, a nonionic, linear gadolinium-based contrast agent supplied at 330.9 mg/mL, equivalent to 0.5 mmol/mL of gadolinium. It was developed for intravenous administration during MRI examinations, including imaging of the central nervous system and other body regions under the approved labeling framework. The product was supplied in single-dose plastic containers in multiple fill volumes.[1]
| Attribute |
OptiMARK in Plastic Container |
| Active ingredient |
Gadoversetamide |
| Drug class |
Gadolinium-based contrast agent |
| Chemical structure |
Linear, nonionic |
| Strength |
330.9 mg/mL; 0.5 mmol/mL gadolinium |
| Dosage form |
Intravenous injection |
| Primary use |
Contrast-enhanced MRI |
| Original U.S. NDA |
NDA 20-601 |
| Packaging |
Single-dose plastic container presentations |
| U.S. regulatory status |
Discontinued in FDA product records |
| Principal historical commercial company |
Mallinckrodt and predecessor organizations |
The plastic container supported sterile, single-use administration and reduced handling requirements compared with certain glass presentations. It did not create a separate clinical indication or materially expand the product’s patent estate.
When did OptiMARK lose exclusivity?
OptiMARK’s commercially relevant exclusivity expired long before the product’s discontinuation. The product entered the U.S. market in the late 1990s, and any original small-molecule composition or formulation exclusivity has elapsed. The product no longer has the characteristics of an actively protected branded MRI contrast agent.
FDA exclusivity for OptiMARK should be separated into three categories:
- NDA exclusivity: Any original approval-based exclusivity has expired.
- Patent exclusivity: The original patent term for the active ingredient and early formulation technology has expired or is no longer commercially decisive.
- Regulatory market status: The product is listed as discontinued, which limits the economic value of any remaining product-specific intellectual property.[2]
A discontinued NDA does not automatically mean that every patent associated with the product has expired. It does mean that surviving patent rights would have limited practical value unless a company sought to restart commercial distribution or protect a new formulation, manufacturing process, or delivery configuration.
What is the Orange Book status of OptiMARK?
OptiMARK’s Orange Book position is commercially weak because the product is discontinued and no longer operates as a major branded reference product. The Orange Book remains relevant for determining whether an approved generic applicant could rely on the historical NDA and whether any listed patents could support a Paragraph IV challenge. It is not, by itself, a measure of active commercial value.
| Orange Book issue |
Commercial assessment |
| Reference product |
Historical OptiMARK NDA |
| Active branded competition |
None of material scale identified |
| Current branded exclusivity |
Expired |
| Product-specific patent leverage |
Limited |
| Generic approval pathway |
Potentially available if an applicant can rely on the reference product and satisfy FDA requirements |
| Litigation value |
Low absent an active listed patent or commercial relaunch |
A generic applicant would need to evaluate whether the discontinued status affects the ability to use the NDA as a reference product and whether the FDA has identified a suitable reference listed drug. The practical route could involve an ANDA, a suitability petition, or another FDA pathway depending on product availability and the agency’s current regulatory treatment.[2]
Which companies challenged or replaced OptiMARK?
No active, material Paragraph IV litigation against OptiMARK is central to the product’s current commercial position. The more important competitive event was therapeutic substitution by other gadolinium-based contrast agents.
Macrocyclic competitors
The principal competitive pressure came from macrocyclic agents, including:
- Gadobutrol, marketed as Gadavist in the United States.
- Gadoterate meglumine, marketed as Dotarem.
- Gadoteridol, marketed as ProHance.
Macrocyclic agents generally form more stable complexes with gadolinium than linear agents. Hospitals and radiology groups increasingly favored macrocyclic products as concerns grew about gadolinium retention and the risk profile of linear agents.
Other linear agents
OptiMARK also competed with other linear contrast agents, including:
- Gadopentetate dimeglumine, marketed historically as Magnevist.
- Gadodiamide, marketed historically as Omniscan.
- Gadoxetate disodium, marketed as Eovist or Primovist for liver imaging.
The competitive effect was not limited to price. It involved formulary policy, renal-risk management, radiologist preference, procurement contracts, and institutional policies governing gadolinium exposure.
How did FDA safety regulation affect OptiMARK demand?
FDA safety communications materially weakened the market position of linear gadolinium agents. The FDA required class-wide labeling changes addressing gadolinium retention and strengthened warnings concerning nephrogenic systemic fibrosis. The agency identified greater retention with linear agents than with macrocyclic agents and required updated patient and health-care-provider information.[3]
OptiMARK also carried historical relevance to nephrogenic systemic fibrosis risk. Gadoversetamide was generally avoided or restricted in patients with severe renal impairment because impaired renal clearance increases exposure to gadolinium and the associated safety concern.[1]
The commercial consequences were direct:
- Hospitals revised MRI contrast formularies.
- Macrocyclic agents gained preference in patients with renal impairment.
- Procurement teams used safety differentiation in contracting decisions.
- Linear agents faced lower utilization even when their acquisition price was competitive.
- Product-specific demand became concentrated in legacy accounts and price-sensitive settings.
The regulatory environment did not require a market-wide withdrawal of all linear agents. It did, however, reduce their strategic value relative to macrocyclic alternatives.
What formulations are protected by OptiMARK patents?
The principal commercial formulation is an aqueous intravenous solution containing gadoversetamide and excipients used to maintain product stability and tonicity. The plastic container is a packaging presentation rather than a separate formulation class.
Potential historical intellectual-property categories included:
- Gadoversetamide composition and chemical structure.
- Aqueous injectable formulations.
- Concentration and dosing configurations.
- Manufacturing and purification processes.
- Container-closure systems.
- MRI contrast-enhancement methods.
These categories do not have equal commercial importance. Composition patents would have been the strongest early barriers, but those rights are no longer a meaningful defense against competition. Formulation and packaging patents could have created narrower protection, yet their value would depend on claim scope, expiration, enforceability, and whether competitors could use alternative containers or excipients.
There is no current indication that the plastic-container presentation provides an enforceable, market-blocking barrier against competing gadolinium products. A rival could generally compete with a different container configuration if it met FDA requirements for sterility, extractables, leachables, stability, and container-closure integrity.
What is the financial trajectory of OptiMARK?
OptiMARK’s product-level revenue trajectory is not publicly disclosed in the available historical filings. Mallinckrodt reported financial results at broader business-segment levels and did not consistently identify OptiMARK revenue as a separate line item.[4]
The product’s likely economic trajectory can be divided into four phases:
| Period |
Financial profile |
Main drivers |
| Launch and early adoption |
Growth product |
MRI expansion, branded contrast pricing, hospital adoption |
| Mature branded period |
Stable or declining revenue |
Established use, competitive products, limited differentiation |
| Post-safety scrutiny |
Accelerating decline |
Linear-agent concerns, renal restrictions, macrocyclic substitution |
| Discontinuation period |
Minimal or zero continuing branded revenue |
Portfolio rationalization, weak demand, limited strategic value |
The product likely generated its strongest economics before the contrast-agent market shifted toward macrocyclic products. After that shift, profitability would have been pressured by lower volume, contracting discounts, manufacturing overhead, regulatory maintenance costs, and the absence of a defensible premium price.
Revenue exposure for the historical manufacturer
OptiMARK was not a large disclosed revenue driver in the public financial reporting of its historical manufacturer. Mallinckrodt’s filings emphasized broader specialty pharmaceutical and specialty generics operations. The company’s reported revenue and earnings were influenced by other products, including controlled substances, specialty pharmaceuticals, and hospital products.[4]
That reporting structure indicates that OptiMARK had limited standalone investor relevance. Its discontinuation would have been unlikely to alter consolidated company revenue materially, although it could have reduced portfolio complexity and eliminate costs related to manufacturing, quality systems, regulatory maintenance, and distribution.
How strong is the OptiMARK patent estate?
The current patent estate is weak from a commercial perspective.
| Patent-strength factor |
Assessment |
| Core composition protection |
Expired or commercially ineffective |
| New chemical entity exclusivity |
Expired |
| Formulation protection |
Narrow and likely expired or avoidable |
| Plastic-container protection |
Limited to packaging-specific claims, if any |
| Method-of-use protection |
Limited practical value for a mature MRI contrast agent |
| Manufacturing protection |
Potentially relevant only to specific processes |
| Litigation leverage |
Low |
| Relaunch protection |
Insufficient without new formulation or delivery claims |
A relaunch would face greater risk from market adoption and regulatory positioning than from direct patent infringement. A company seeking to commercialize gadoversetamide would need to address the product’s linear-agent profile, clinical positioning, supply-chain economics, and FDA requirements. Patent clearance alone would not establish a viable business case.
What generic entry risks exist for OptiMARK?
Generic entry risk is structurally high because the product’s core exclusivity has expired and the active ingredient is a conventional small molecule. The principal barriers are regulatory and commercial rather than patent-based.
Regulatory barriers
A generic or follow-on applicant would need to demonstrate:
- Pharmaceutical equivalence.
- Bioequivalence or an appropriate alternative standard for an intravenously administered product.
- Sterility and particulate control.
- Container-closure integrity.
- Stability in the proposed plastic container.
- Compatibility with MRI administration equipment.
- Compliance with labeling and renal-risk requirements.
Commercial barriers
Even if approved, a new supplier would face:
- Limited market demand for a discontinued linear agent.
- Strong institutional preference for macrocyclic agents.
- Contracting pressure from group purchasing organizations.
- Need for reliable sterile injectable manufacturing capacity.
- Potentially low volumes that do not justify dedicated production.
- Physician and hospital reluctance to return to a legacy product.
The most credible generic launch scenario would involve a low-cost supplier targeting residual demand, shortage situations, or markets where macrocyclic agents carry a material price premium. A broad return to branded-market share is unlikely without new clinical or economic differentiation.
What patent litigation affects OptiMARK?
No major current patent litigation is associated with OptiMARK’s commercial position. The product’s decline was driven primarily by market substitution, regulatory risk management, and discontinuation rather than by a high-value patent dispute.
A historical litigation review should distinguish among:
- Paragraph IV litigation over an active Orange Book patent.
- ANDA litigation involving a generic gadoversetamide applicant.
- Product-liability or safety litigation involving gadolinium retention or nephrogenic systemic fibrosis.
- Commercial disputes involving distribution or supply.
These categories have different implications. Patent litigation could delay generic entry, but safety-related claims would affect liability exposure rather than exclusivity. For OptiMARK, the dominant issue is the lack of a commercially attractive market after the product’s discontinuation.
How does OptiMARK compare with Gadavist and Dotarem?
| Factor |
OptiMARK |
Gadavist |
Dotarem |
| Active ingredient |
Gadoversetamide |
Gadobutrol |
Gadoterate meglumine |
| Molecular class |
Linear, nonionic |
Macrocyclic |
Macrocyclic |
| Current market position |
Discontinued or inactive |
Active branded product |
Active branded product |
| Safety positioning |
Weaker in current formulary environment |
Stronger macrocyclic positioning |
Stronger macrocyclic positioning |
| Patent relevance |
Historical, low current value |
Commercially material during exclusivity |
Commercially material during exclusivity |
| Hospital demand |
Legacy or minimal |
Broad |
Broad |
| Price strategy |
Generic or discontinued economics |
Brand and contract pricing |
Brand and contract pricing |
Gadavist and Dotarem benefited from the market’s preference for macrocyclic agents. OptiMARK’s lower strategic value reflects both its discontinued status and its less favorable positioning in a market increasingly focused on gadolinium stability and retention.
What is the geographic coverage of OptiMARK?
OptiMARK was marketed in the United States and had international commercial relevance under the gadoversetamide name, although country-specific availability and status varied. Drug approval, packaging, labeling, reimbursement, and discontinuation decisions were jurisdiction-specific.
The United States remains the most important jurisdiction for assessing:
- FDA approval status.
- Orange Book treatment.
- Generic approval pathways.
- U.S. patent expiration.
- Product discontinuation.
- Hospital purchasing behavior.
European and other international markets applied separate regulatory frameworks. Their treatment of gadolinium agents also shifted toward macrocyclic products, limiting the ability to preserve global demand through geographic diversification.
What manufacturing and intellectual-property barriers remain?
The principal manufacturing barrier is sterile injectable production. Gadoversetamide is not difficult to protect through core composition patents at this stage, but a commercial supplier would need validated aseptic processing, high-quality container systems, reliable raw-material sourcing, and regulatory-compliant release testing.
The plastic container creates specific technical requirements:
- Low extractables and leachables.
- Resistance to interaction with the formulation.
- Adequate oxygen and moisture protection.
- Container-closure integrity throughout shelf life.
- Compatibility with automated MRI injectors.
- Control of particulate matter and fill-volume accuracy.
These requirements can increase development and validation costs, but they do not appear to create a durable market barrier. Competitors can use alternative container systems if they meet the applicable quality and regulatory standards.
Key Takeaways
- OptiMARK in Plastic Container is gadoversetamide injection, a linear, nonionic gadolinium-based MRI contrast agent.
- The product is listed as discontinued in FDA product records.
- Original composition, regulatory, and commercial exclusivity has expired or no longer provides meaningful market protection.
- No current high-value Paragraph IV or patent litigation is central to the product’s position.
- Macrocyclic agents such as Gadavist and Dotarem displaced OptiMARK in many hospital formularies.
- FDA warnings on gadolinium retention and nephrogenic systemic fibrosis weakened demand for linear agents.
- Public filings do not provide standalone OptiMARK revenue, so product-specific financial exposure cannot be quantified from reported company results.
- Any residual value lies in low-cost generic supply, shortage coverage, or selected price-sensitive markets.
- The plastic container creates quality and manufacturing obligations, not a durable competitive moat.
- A commercial relaunch would face greater demand and formulary risk than patent risk.
FAQs
Is OptiMARK still available in the United States?
FDA records identify OptiMARK as discontinued. It is not positioned as an actively marketed branded MRI contrast agent in the current U.S. market.[2]
Is gadoversetamide the same as gadobutrol?
No. Gadoversetamide is the active ingredient in OptiMARK and is a linear gadolinium agent. Gadobutrol is the active ingredient in Gadavist and is a macrocyclic gadolinium agent.
Can a company launch a generic version of OptiMARK?
A company could evaluate an abbreviated or other FDA regulatory pathway, but approval would require compliance with intravenous product, sterility, formulation, container, and labeling requirements. The commercial case is constrained by low demand and competition from macrocyclic agents.
Does the OptiMARK plastic container have separate patent protection?
The container may have been covered by packaging or container-closure claims, but the packaging presentation does not create separate protection for gadoversetamide itself. Any surviving claims would require a current patent and narrowly defined claim scope.
Why did hospitals move away from OptiMARK?
Hospitals increasingly favored macrocyclic gadolinium agents because of their stronger gadolinium-binding characteristics and more favorable positioning after regulatory attention to gadolinium retention and nephrogenic systemic fibrosis.
References
- U.S. Food and Drug Administration. (n.d.). OptiMARK (gadoversetamide injection) prescribing information. FDA.
- U.S. Food and Drug Administration. (n.d.). Drugs@FDA: OptiMARK, NDA 020601; Orange Book product and patent information. FDA.
- U.S. Food and Drug Administration. (2018, May 16). FDA identifies no important new safety risks associated with gadolinium-based contrast agents for MRI. FDA.
- Mallinckrodt plc. (Various years). Annual reports and Form 10-K filings. Mallinckrodt plc.
