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:	1
Clinical Trials:	3
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/000745 This 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
Japan	2815556
Hong Kong	130797	Novel magnetic resonance imaging agents
Brazil	1101072
Singapore	49063	Novel magnetic resonance imaging agents
Japan	H0920785	NONIONIC PARAMAGNETIC ION COMPLEX AND COMPLEXING AGENT FOR FORMING THE SAME
Canada	1339821	AGENTS D'IMAGERIE PAR RESONANCE MAGNETIQUE (MAGNETIC RESONANCE IMAGING AGENTS)
Austria	142614

Supplementary Protection Certificates for OPTIMARK IN PLASTIC CONTAINER

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

OPTIMARK IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OptiMARK in Plastic Containers

Introduction

OptiMARK, a gadoversetamide injection, is a paramagnetic agent used in magnetic resonance imaging (MRI) to enhance the visibility of internal body structures. This article delves into the market dynamics and financial trajectory of OptiMARK, particularly when packaged in plastic containers.

Product Overview

OptiMARK is a complex formed between a chelating agent (versetamide) and a paramagnetic ion, gadolinium (III). It is administered intravenously and enhances the relaxation rates of water protons, leading to increased signal intensity in MRI images[1][4].

Market Segments and Demand

The demand for OptiMARK is part of the broader medical imaging market, which includes contrast agents used in MRI and other imaging modalities. Here are some key market segments and demand drivers:

Medical Imaging Market

The medical imaging market, including contrast agents like OptiMARK, is driven by the increasing need for diagnostic imaging in healthcare. This market is expanding due to the growing prevalence of chronic diseases and the need for accurate diagnoses[2].

Pharmaceutical Packaging Market

The pharmaceutical packaging market, particularly for plastic containers, is experiencing significant growth. This is due to the development of various medications and drugs, as well as the increasing prevalence of chronic diseases globally. The global pharmaceutical plastic packaging market is projected to grow at a CAGR of 5.8% from 2023 to 2033[3].

Packaging Considerations

Plastic Containers

OptiMARK is typically packaged in plastic containers, which offer several advantages over traditional glass packaging. These include lower production costs and wider availability. The shift towards plastic packaging is also driven by the need for child-resistant and tamper-evident packaging solutions, which are crucial for safety and regulatory compliance[3].

Safety and Regulatory Compliance

Packaging solutions for OptiMARK must adhere to strict safety and regulatory standards. This includes the use of child-resistant caps and closures, as well as anti-counterfeiting features. These measures are essential for ensuring the safe delivery of the drug and complying with regulatory guidelines[3].

Financial Trajectory

Revenue and Market Size

The financial trajectory of OptiMARK is influenced by the overall performance of its parent company and the broader pharmaceutical market. Mallinckrodt, the company behind OptiMARK, has a strong position in the medical imaging segment, which accounted for 43.5% of their net sales in fiscal 2013. The company's commitment to research and development and its extensive portfolio of pharmaceutical products contribute to its financial stability[2].

Growth Projections

The pharmaceutical plastic packaging market, which includes the packaging for OptiMARK, is expected to reach USD 96,339.2 million by 2033, growing at a CAGR of 5.8% from 2023 to 2033. This growth is driven by the increasing demand for pharmaceutical products and the need for advanced packaging solutions[3].

Regional Market Performance

In regions like North America and Europe, the market growth for pharmaceutical plastic packaging is expected to be moderate due to restrictions on the use of plastic materials. However, there is a significant positive trend anticipated as manufacturers adapt to new guidelines and regulations, such as those set by the European Union[3].

Competitive Landscape

Market Competition

The market for contrast agents like OptiMARK is competitive, with several players offering similar products. Mallinckrodt faces competition from other pharmaceutical companies, particularly in the generic drug market. However, its strong formulation and manufacturing expertise, along with a commitment to research and development, help maintain its market position[2].

Differentiation Strategies

To differentiate itself, Mallinckrodt focuses on developing innovative products and packaging solutions. For example, the emphasis on tamper-evident and anti-counterfeiting features in plastic packaging helps the company stand out in a competitive market[3].

Regulatory and Safety Considerations

Clinical Trials and Safety Data

OptiMARK has undergone extensive clinical trials and safety studies. These studies have highlighted potential adverse effects, such as maternal toxicity and effects on fetal development at high doses. However, these effects are generally not observed at doses equivalent to the human dose based on body surface area[1][4].

Regulatory Compliance

The drug must comply with regulatory standards set by bodies like the FDA. OptiMARK is classified under Pregnancy Category C, indicating that it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus[1][4].

Key Takeaways

• Growing Demand: The demand for OptiMARK is driven by the expanding medical imaging market and the need for advanced diagnostic tools.
• Packaging Trends: The shift towards plastic packaging due to lower costs and wider availability is a significant trend.
• Regulatory Compliance: Adherence to safety and regulatory standards is crucial for the packaging and distribution of OptiMARK.
• Financial Growth: The financial trajectory of OptiMARK is positive, with growth projections aligned with the broader pharmaceutical plastic packaging market.
• Competitive Landscape: Mallinckrodt's strong R&D capabilities and focus on innovative packaging solutions help maintain its market position.

FAQs

What is OptiMARK used for?

OptiMARK is a paramagnetic agent used in magnetic resonance imaging (MRI) to enhance the visibility of internal body structures.

What are the potential adverse effects of OptiMARK?

OptiMARK can cause adverse effects such as headache, vasodilatation, taste perversion, dizziness, nausea, and paresthesia. High doses can also affect fetal development and male reproductive health in animal studies[1][4].

Why is plastic packaging preferred for OptiMARK?

Plastic packaging is preferred due to its lower production costs, wider availability, and the ability to incorporate child-resistant and tamper-evident features[3].

What is the projected growth rate of the pharmaceutical plastic packaging market?

The pharmaceutical plastic packaging market is projected to grow at a CAGR of 5.8% from 2023 to 2033[3].

How does Mallinckrodt differentiate itself in the market?

Mallinckrodt differentiates itself through its strong formulation and manufacturing expertise, commitment to research and development, and innovative packaging solutions[2].

Sources

1. OptiMARK™ 0.5 mmol/mL (Gadoversetamide Injection) Label - FDA.
2. Mallinckrodt Public Limited Company - Investor Relations - Mallinckrodt.
3. Pharmaceutical Plastic Packaging Market & Forecast by 2033 - Future Market Insights.
4. OptiMARK - accessdata.fda.gov - FDA.