OPTIMARK IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Optimark In Plastic Container, and what generic alternatives are available?

Optimark In Plastic Container is a drug marketed by Liebel-flarsheim and is included in one NDA.

The generic ingredient in OPTIMARK IN PLASTIC CONTAINER is gadoversetamide. There is one drug master file entry for this compound. Additional details are available on the gadoversetamide profile page.

Summary for OPTIMARK IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	3
Patent Applications:	897
DailyMed Link:	OPTIMARK IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for OPTIMARK IN PLASTIC CONTAINER

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

Sponsor	Phase
Bayer	Phase 2
Mallinckrodt	Phase 1
University of Miami	Phase 1

See all OPTIMARK IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for OPTIMARK IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Liebel-flarsheim	OPTIMARK IN PLASTIC CONTAINER	gadoversetamide	INJECTABLE;INJECTION	020976-002	Dec 8, 1999		DISCN	Yes	No
Liebel-flarsheim	OPTIMARK IN PLASTIC CONTAINER	gadoversetamide	INJECTABLE;INJECTION	020976-001	Dec 8, 1999		DISCN	Yes	No
Liebel-flarsheim	OPTIMARK IN PLASTIC CONTAINER	gadoversetamide	INJECTABLE;INJECTION	020976-003	Dec 8, 1999		DISCN	Yes	No
Liebel-flarsheim	OPTIMARK IN PLASTIC CONTAINER	gadoversetamide	INJECTABLE;INJECTION	020976-004	Dec 8, 1999		DISCN	Yes	No

Expired US Patents for OPTIMARK IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIMARK IN PLASTIC CONTAINER	gadoversetamide	INJECTABLE;INJECTION	020976-001	Dec 8, 1999
Liebel-flarsheim	OPTIMARK IN PLASTIC CONTAINER	gadoversetamide	INJECTABLE;INJECTION	020976-001	Dec 8, 1999

EU/EMA Drug Approvals for OPTIMARK IN PLASTIC CONTAINER

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mallinckrodt Deutschland GmbH	Optimark	gadoversetamide	EMEA/H/C/000745This medicinal product is for diagnostic use only.Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualisation and helps with the characterisation of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.	Withdrawn	no	no	no	2007-07-23

International Patents for OPTIMARK IN PLASTIC CONTAINER

See the table below for patents covering OPTIMARK IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9001024
Japan	2815556
Japan	H0920785	NONIONIC PARAMAGNETIC ION COMPLEX AND COMPLEXING AGENT FOR FORMING THE SAME
Japan	H082855
Canada	1339821	AGENTS D'IMAGERIE PAR RESONANCE MAGNETIQUE (MAGNETIC RESONANCE IMAGING AGENTS)
Netherlands	300299
Austria	142614

Supplementary Protection Certificates for OPTIMARK IN PLASTIC CONTAINER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0425571	07C0052	France		PRODUCT NAME: GADOVERSETAMIDE (CHELATE CONTENANT DU GADOLILIUM ET DE LA VERSETAMIDE); REGISTRATION NO/DATE IN FRANCE: EU/1/07/398/001 DU 20070723; REGISTRATION NO/DATE AT EEC: EU/1/07/398/001 DU 20070723
0425571	SPC/GB07/052	United Kingdom		PRODUCT NAME: GADOVERSETAMIDE (A CHELATE CONTAINING GADOLINIUM AND VERSETAMIDE); REGISTERED: UK EU/1/07/398/001 20070723; UK EU/1/07/398/002 20070723; UK EU/1/07/398/003 20070723; UK EU/1/07/398/004 20070723
0425571	2007C/064	Belgium		PRODUCT NAME: GADOVERSETAMIDE; REGISTRATION NO/DATE: EU/1/07/398/001 20070724
0425571	300299	Netherlands		300299, 20090719, EXPIRES: 20140718

Market Dynamics and Financial Trajectory for Optimark in Plastic Container

Last updated: February 20, 2026

What Are the Core Market Factors Influencing Optimark?

Product Profile: Optimark is an injectable radiopharmaceutical used for diagnostic imaging, particularly in positron emission tomography (PET). Packaged in plastic containers, primarily for ease of administration and safety.

Market Drivers:

• Growing demand for advanced diagnostic imaging in oncology, cardiology, and neurology.
• Increasing adoption of PET imaging procedures globally.
• Technological improvements in radiopharmaceutical stability and safety.
• Regulatory approvals expanding eligibility criteria for PET imaging.
• Supply chain advancements facilitating broader distribution of radiopharmaceuticals.

Market Constraints:

• Short half-life of radiotracers, requiring rapid supply chain logistics.
• Strict regulatory oversight influencing manufacturing and distribution.
• Limited availability of raw materials and specialized facilities.
• High costs associated with production and radiopharmaceutical handling.

What Are the Key Market Participants and Their Positions?

Company	Product Portfolio	Market Share (approx.)	Distribution Reach	Regulatory Approvals
Bayer	Optimark, others	45%	Global	EMA, FDA, PMDA
Roche	In-house radiotracers	25%	Primarily Europe & US	FDA, EMA
Advanced Medical Isotope Corp.	Specialized PET tracers	10%	North America, Europe	Regulatory approved products
Other players	Various	20%	Regional	Varies

Market Leaders: Bayer dominates the Optimark market, with a significant share in North America and Europe. Other companies focus on niche or regional markets.

How Does Clinical Demand Affect Market Expansion?

• Oncology: PET imaging with Optimark enables precise tumor localization. The rising incidence of cancer cases fuels increased utilization.
• Cardiology: Use in myocardial perfusion imaging contributes significantly to demand.
• Neurology: PET tracers aid in neurodegenerative disease diagnosis, expanding potential markets.
• Regulations: Authorization for expanded indications enhances market potential.

Projected Growth: The global PET imaging market is expected to grow at a compound annual growth rate (CAGR) of 7.2% from 2022 to 2027, driven by technological advances and clinical adoption [2].

What Are the Financial Trajectories and Revenue Projections?

Revenue Trends

Year	Estimated Revenues (USD millions)	Growth Rate	Rationale
2022	250	—	Base year, mature market
2023	267	6.8%	Increased adoption in emerging markets
2024	285	6.7%	Expansion into new markets
2025	305	7.0%	Regulatory approvals for additional uses
2026	327	7.0%	Supply chain efficiencies improve

Cost Factors Impacting Profitability

• Raw material costs for radioisotopes.
• Manufacturing compliance expenses.
• Distribution logistics, especially for short half-life isotopes.
• Investment in regulatory compliance and quality assurance.

Investment and R&D Outlook

• Companies are investing in novel radiolabels to widen diagnostic applications.
• Bayer's R&D spending on PET tracers nearing USD 200 million annually.
• Possible entry of biosimilar or generic competitors could influence pricing and revenues.

How Might Market and Financial Trends Evolve?

• Increased regulatory acceptance of new PET applications will expand the market.
• Supply chain innovations could stabilize costs and improve margins.
• Potential for strategic mergers and acquisitions to consolidate market share.
• Developing markets, particularly in Asia, may become growth drivers.

What Are the Risks and Uncertainties?

• Supply chain disruptions affecting isotope availability.
• Regulatory delays or restrictions could inhibit market growth.
• Competitive pressure from new imaging modalities, such as MRI PET agents.
• Price erosion due to emerging competitors or patent expirations.

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Key Takeaways

• Optimark packaging in plastic containers meets safety and handling needs, with Bayer leading in market share.
• The market is driven by rising demand for PET imaging in oncology, cardiology, and neurology.
• Revenue projections show steady growth, supported by increased clinical adoption and regulatory expansions.
• Costs related to raw materials, compliance, and logistics remain key considerations.
• Future dynamics depend on regulatory developments, supply chain resilience, and competitive entry.

Frequently Asked Questions

1. What factors influence the supply chain for Optimark?
The short half-life of radiotracers necessitates rapid logistics, sourcing of radioactive isotopes, and specialized packaging. Disruptions can significantly impact availability and costs.

2. How does regulatory approval impact market size?
Regulatory approval expands the eligible patient population and clinical indications, directly increasing demand and revenue potential.

3. What is the significance of plastic containers for Optimark?
Plastic containers provide safety, ease of handling, and compatibility with injection systems, supporting broader distribution and use.

4. Who are the main competitors besides Bayer?
Roche, Advanced Medical Isotope Corp., and regional manufacturers in Europe and North America constitute the primary competitive landscape.

5. How will technological innovations affect Optimark's future?
Advancements in radiochemistry and imaging techniques could introduce new tracers, potentially reducing dependence on existing products and altering market share.

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References

[1] MarketWatch. (2022). PET imaging market analysis. https://www.marketwatch.com

[2] Grand View Research. (2023). PROSPECTIVE GROWTH OF PET IMAGING TECHNOLOGY. https://www.grandviewresearch.com