OPTIMARK Drug Patent Profile

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

Optimark is a drug marketed by Liebel-flarsheim and is included in three NDAs.

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

Summary for OPTIMARK

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	3
Patent Applications:	1,091
Drug Prices:	Drug price information for OPTIMARK
DailyMed Link:	OPTIMARK at DailyMed

See drug prices for OPTIMARK

Recent Clinical Trials for OPTIMARK

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

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

See all OPTIMARK clinical trials

US Patents and Regulatory Information for OPTIMARK

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	gadoversetamide	INJECTABLE;INJECTION	020975-001	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	gadoversetamide	INJECTABLE;INJECTION	020937-003	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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-004	Dec 8, 1999
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-002	Dec 8, 1999
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-004	Dec 8, 1999
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020975-001	Dec 8, 1999

EU/EMA Drug Approvals for OPTIMARK

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

See the table below for patents covering OPTIMARK 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

Supplementary Protection Certificates for OPTIMARK

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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OptiMARK

Introduction

OptiMARK, a gadolinium-based contrast agent, is used in magnetic resonance imaging (MRI) to enhance the visibility of internal body structures. Understanding its market dynamics and financial trajectory is crucial for stakeholders in the pharmaceutical and medical imaging industries.

Market Overview

The global market for contrast agents, including OptiMARK, is part of the broader sterile injectable drugs market. This market has been experiencing significant growth driven by advancements in medical technology and an increasing demand for diagnostic imaging.

Global Market for Sterile Injectable Drugs

The global market for sterile injectable drugs was estimated at $732.0 billion in 2023 and is projected to reach $1.4 trillion by 2030, growing at a CAGR of 9.7% from 2023 to 2030. This growth is fueled by the rising focus on personalized and precision medicine, where sterile injectable drugs, including biologics and gene therapies, play a critical role[3].

Segmentation and Growth

The sterile injectable drugs market is segmented into small molecule drugs and large molecule drugs. The small molecule drugs segment is expected to reach $577.6 billion by 2030 with a CAGR of 9.4%, while the large molecule drugs segment is set to grow at a CAGR of 9.9% over the same period. Given that OptiMARK is a small molecule drug, it benefits from this segment's growth trajectory[3].

Regional Analysis

The U.S. market for sterile injectable drugs was estimated at $203.1 billion in 2023, while China is forecasted to grow at an impressive 9.0% CAGR to reach $213.0 billion by 2030. Other key regions, including Japan, Canada, Germany, and the Asia-Pacific, also show promising growth trends. OptiMARK's market performance is likely influenced by these regional dynamics[3].

Competitive Landscape

The market for gadolinium-based contrast agents is competitive, with several products available, including OptiMARK, Gadavist, and Dotarem. Each of these products has its own clinical and safety profiles, which can influence market share. For instance, Dotarem has been approved for use in pediatric patients younger than age 2 outside the United States, which could impact OptiMARK's market share in certain demographics[2].

Clinical and Safety Profile

OptiMARK's clinical and safety profile is a critical factor in its market dynamics. The drug is associated with risks such as nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of gadolinium, which can affect its adoption rates. However, it has a well-documented pharmacokinetic profile, with distribution and elimination half-lives of approximately 13.3 and 103.6 minutes, respectively. It is also effectively cleared by hemodialysis, which is important for patients with renal impairment[1][4].

Financial Performance

While specific financial data for OptiMARK is not readily available, the overall revenue trends of companies involved in diagnostic imaging can provide insights. For example, Guerbet, a company involved in diagnostic imaging, reported revenue of €400.6 million for the first half of 2019, with diagnostic imaging revenue growing 2.2% to €351.9 million. This indicates a stable and growing market for diagnostic imaging products, including contrast agents like OptiMARK[5].

Regulatory and Safety Considerations

Regulatory approvals and safety assessments significantly impact the financial trajectory of OptiMARK. The FDA's approval and ongoing safety monitoring, including postmarket experience, are crucial. For instance, the FDA has approved modifications to the packaging of similar products like Gadavist, which can influence the overall market dynamics for gadolinium-based contrast agents[2].

Clinical Trials and Efficacy

OptiMARK has been studied in various clinical trials, involving over 1,300 subjects, which have helped establish its efficacy and safety profile. These trials have shown that while OptiMARK is generally well-tolerated, it can cause adverse events, and its use must be carefully managed, especially in patients with certain health conditions[4].

Impact on Patient Care and Market Demand

The effectiveness of OptiMARK in enhancing MRI images directly impacts patient care and market demand. As diagnostic imaging continues to play a vital role in healthcare, the demand for high-quality contrast agents like OptiMARK is expected to remain strong.

Future Outlook

Given the growing demand for diagnostic imaging and the advancements in medical technology, the market for OptiMARK and similar contrast agents is expected to continue growing. However, this growth will be influenced by factors such as regulatory approvals, safety profiles, and competitive market dynamics.

Key Takeaways

• Market Growth: The global market for sterile injectable drugs, including OptiMARK, is projected to grow significantly by 2030.
• Regional Dynamics: The U.S. and China are key markets with high growth potential.
• Clinical and Safety Profile: OptiMARK's safety profile, including risks like NSF, and its pharmacokinetics are crucial for its market performance.
• Regulatory Considerations: FDA approvals and ongoing safety monitoring are vital.
• Clinical Trials: Extensive clinical trials have established OptiMARK's efficacy and safety.

FAQs

Q: What is the primary use of OptiMARK in medical imaging? A: OptiMARK is used as a gadolinium-based contrast agent to enhance the visibility of internal body structures during magnetic resonance imaging (MRI).

Q: What are the potential risks associated with OptiMARK? A: OptiMARK is associated with risks such as nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of gadolinium.

Q: How is OptiMARK cleared from the body? A: OptiMARK is cleared from the body through hemodialysis, with approximately 98% of the administered dose cleared over three dialysis sessions.

Q: What is the projected growth of the sterile injectable drugs market? A: The global market for sterile injectable drugs is projected to reach $1.4 trillion by 2030, growing at a CAGR of 9.7% from 2023 to 2030.

Q: Are there any regional market trends that could impact OptiMARK's sales? A: Yes, regions like the U.S. and China are expected to show significant growth, with China forecasted to grow at a 9.0% CAGR to reach $213.0 billion by 2030.

Cited Sources:

1. OptiMARK™ 0.5 mmol/mL (Gadoversetamide Injection) Label - FDA.
2. N201-277S008 Gadobutrol Clinical PREA - FDA.
3. Sterile Injectable Drugs - Global Strategic Business Report - GlobeNewswire.
4. OptiMARK - accessdata.fda.gov - FDA.
5. Revenue at 30 June 2019 - Guerbet.