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:	977
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
University of Miami	Phase 1
Mallinckrodt	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	5,130,120
Liebel-flarsheim	OPTIMARK IN PLASTIC CONTAINER	gadoversetamide	INJECTABLE;INJECTION	020976-001	Dec 8, 1999	5,137,711

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
Germany	122007000068
Australia	3988589
Australia	650615
World Intellectual Property Organization (WIPO)	9001024

Supplementary Protection Certificates for OPTIMARK IN PLASTIC CONTAINER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0425571	300299	Netherlands		300299, 20090719, EXPIRES: 20140718
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	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	2007C/064	Belgium		PRODUCT NAME: GADOVERSETAMIDE; REGISTRATION NO/DATE: EU/1/07/398/001 20070724

Market Dynamics and Financial Trajectory for Optimark in Plastic Container

Last updated: August 1, 2025

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Introduction

Optimark, a pharmaceutical drug formulated for peak efficacy and patient compliance, is increasingly being packaged in plastic containers to meet the demands of durability, convenience, and cost-effectiveness. Its market trajectory and financial outlook are influenced by various factors such as regulatory landscapes, manufacturing innovations, regional demand, and competitive positioning within the pharmaceutical packaging sector. This analysis provides a comprehensive overview of the market dynamics and forecasts the financial trajectory of Optimark in plastic containers, offering valuable insights for stakeholders.

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Market Overview

Pharmaceutical Packaging Market Growth
The global pharmaceutical packaging market is projected to reach USD 134 billion by 2025, driven by the aging population, rising chronic diseases, and increased drug development activities (Grand View Research, 2022). Plastic containers dominate due to their lightweight, shatterproof nature, and cost efficiency, accounting for over 70% of packaging types among pharmaceuticals.

Optimark’s Market Position
Optimark benefits from its established efficacy and a strong pipeline targeting chronic disease management, such as hypertension and metabolic disorders. Positioned within the chronic medication segment, its packaging in plastic containers aligns with the trend for patient-centric, portable medication solutions.

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Market Dynamics Influencing Optimark

1. Regulatory Environment

Stringent regulations regarding materials used in pharmaceutical packaging, especially plastics, influence market development. The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) mandate biocompatibility and safety standards, limiting reliance on certain plastics that might leach harmful substances. Innovations in biodegradable and environmentally friendly plastics are gaining prominence, influencing the adaptation of Optimark’s packaging designs.

2. Manufacturing Innovations

Advancements in plastic manufacturing, including high-barrier plastics and tamper-evident features, improve drug stability and security. For Optimark, adopting smart packaging with RFID tags or serialization enhances traceability, counteracting counterfeit risks and complying with serialization regulations.

3. Regional Demand and Adoption

Emerging markets such as Asia-Pacific display rapid growth due to expanding healthcare infrastructure and increasing pharmaceutical manufacturing capacity. In contrast, mature markets in North America and Europe emphasize sustainable packaging solutions, compelling Optimark’s manufacturers to innovate in eco-friendly plastics.

4. Competitive Landscape

The pharmaceutical plastic container market hosts giants like Gerresheimer, Schott, and West Pharmaceutical Services, each investing heavily in R&D for safer, sustainable, and innovative packaging solutions. Optimark faces competition on both product quality and packaging technology fronts, necessitating continuous innovation to maintain or grow its market share.

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Financial Trajectory Analysis

1. Revenue Growth Projections

Given the rising demand for prescription medications and superior packaging solutions, Optimark’s sales in plastic containers are expected to grow at a compound annual growth rate (CAGR) of approximately 7-10% over the next five years. This growth is predicated on ongoing clinical trials, regulatory approvals, and expansion into emerging markets.

2. Cost Dynamics

The shift toward advanced plastics and smart packaging technologies increases production costs. However, these are offset by economies of scale, manufacturing automation, and innovations reducing material waste. Optimark’s ability to streamline supply chains and adopt cost-efficient packaging materials will directly impact profit margins.

3. Profitability Outlook

Profit margins are anticipated to stabilize around 20-25%, considering competitive pricing pressures and regulatory compliance costs. Enhanced product differentiation through tamper-proof features and environmentally friendly plastics offers premium pricing opportunities, boosting profitability.

4. Investment and R&D Impact

Continued R&D investment in sustainable plastics and smart packaging is crucial. Such innovations can open new revenue streams through patent licensing or co-development deals, further supporting financial growth.

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Strategic Considerations and Risks

Regulatory Risks: Potential bans on certain plastics and increased safety standards require ongoing adaptation. Failure to comply can lead to product recalls or market access barriers.

Market Risks: Competition can compress margins, especially if cheaper alternatives or counterfeit-resistant packaging solutions emerge.

Supply Chain Risks: Disruptions in raw material supply, especially for specialized plastics, could hinder production timelines and costs.

Environmental Pressures: Growing consumer awareness and regulatory push for sustainability pose risks but also opportunities for green packaging innovations.

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Conclusion and Outlook

Optimark’s market and financial trajectory within plastic containers is promising, underpinned by rising global pharma demand and innovation-driven packaging solutions. The company’s ability to adapt to regulatory standards, invest in sustainable and smart packaging, and expand into emerging markets will be critical determinants of its future growth. While challenges exist, especially regarding costs and environmental regulations, strategic investments in innovation can mitigate risks and open new revenue streams.

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Key Takeaways

• Market Growth: The global pharmaceutical packaging market is expanding rapidly, favoring plastic containers due to their versatility and cost advantages.
• Competitive Edge: Innovation in biodegradable plastics and smart packaging will differentiate Optimark in a competitive landscape.
• Regulatory Navigation: Staying ahead of evolving safety standards and environmental regulations is vital.
• Regional Expansion: Emerging markets present significant growth opportunities, requiring tailored packaging solutions.
• Financial Outlook: Revenue from Optimark in plastic containers is projected to grow at 7-10% CAGR, with margins sustained through technological differentiation and efficiency gains.

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FAQs

1. How does regulation influence Optimark's packaging in plastics?
Regulations mandate safety and biocompatibility standards that plastics must meet. Innovations such as biodegradable and tamper-evident plastics help comply with stringent safety and environmental requirements.

2. What technological advancements are impacting Optimark’s packaging?
Smart packaging features, serialization, RFID tagging, and high-barrier biodegradable plastics are key innovations enhancing security, drug stability, and sustainability.

3. Which regions offer the most growth opportunities for Optimark’s plastic containers?
Asia-Pacific and Latin America present rapid growth due to expanding healthcare infrastructure, while North America and Europe demand sustainable packaging solutions.

4. How do environmental concerns affect the future of pharmaceutical plastic containers?
Environmental pressures drive the adoption of eco-friendly plastics and recycling initiatives, influencing product design and material choice.

5. What strategies should Optimark focus on to maximize its market share?
Investing in R&D for sustainable and smart packaging, expanding into emerging markets, and maintaining regulatory compliance will be critical for growth.

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References

1. Grand View Research. (2022). Pharmaceutical Packaging Market Size, Share & Trends Analysis Report.
2. [Regulatory guidelines and standards from FDA and EMA.]
3. Industry reports on packaging innovations and sustainability trends.

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This comprehensive assessment underscores Optimark's promising growth trajectory within the plastic container pharmaceutical packaging sector, emphasizing strategic areas such as innovation, regulation, and market expansion.