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:	11
Clinical Trials:	3
Patent Applications:	977
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
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-001	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	020937-003	Dec 8, 1999	5,130,120
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020975-001	Dec 8, 1999	5,130,120
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-003	Dec 8, 1999	5,137,711
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-004	Dec 8, 1999	5,130,120
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-002	Dec 8, 1999	5,137,711

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/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

See the table below for patents covering OPTIMARK around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	122007000068
Australia	3988589
Australia	650615
World Intellectual Property Organization (WIPO)	9001024
Japan	H04507084

Supplementary Protection Certificates for OPTIMARK

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 the Pharmaceutical Drug: OPTIMARK

Last updated: July 28, 2025

Introduction

OPTIMARK, a novel pharmaceutical agent, is gaining prominence within the pharmaceutical landscape due to its targeted therapeutic profile. Its development, regulatory approval, and commercialization are integral to understanding its potential market impact. This analysis explores the key market dynamics influencing OPTIMARK’s trajectory, including competitive positioning, regulatory environment, market demand, and financial prospects driven by sales forecasts and investment trends.

Product Overview

OPTIMARK is a prescription drug designed primarily for the treatment of [specific indication, e.g., autoimmune disorders]. Leveraging a unique molecular mechanism, it offers improved efficacy and safety over existing therapies. As an emerging entrant, OPTIMARK aims to position itself strategically in a competitive therapeutic area, with ongoing clinical trials and regulatory efforts underpinning its future market potential.

Market Environment and Competitive Landscape

Therapeutic Area and Market Size

The targeted indication for OPTIMARK is a highly lucrative segment. The global market for [indication] was valued at approximately $X billion in 2022, with an anticipated compound annual growth rate (CAGR) of X% through 2030 (source: [1]). This growth is fueled by rising prevalence, advances in diagnostic criteria, and expanding treatment paradigms. The competitive landscape features established biologics and small-molecule drugs from entities such as [major competitors], with OPTIMARK’s differentiated profile potentially capturing significant market share.

Competitive Advantages

OPTIMARK’s differentiators include enhanced efficacy, reduced adverse events, and an improved dosing regimen. These factors could translate into higher adoption rates among clinicians and patients, especially if early clinical data validate its superior profile. Additionally, the drug's delivery technology or formulation enhancements may enable a more convenient patient experience, further solidifying its market position.

Regulatory and Reimbursement Dynamics

Regulatory Pathways

The pathway to market hinges upon successful completion of pivotal Phase III trials, followed by submission of a New Drug Application (NDA) or Biological License Application (BLA). The regulatory environment remains complex, with expedited pathways such as Breakthrough Therapy Designation or Priority Review potentially expediting approval timelines, contingent on early evidence of substantial benefit.

Pricing and Reimbursement Considerations

Post-approval, reimbursement negotiations with payers will significantly influence OPTIMARK’s financial success. Value-based pricing models are increasingly prevalent, assessing the drug’s clinical benefits against costs. Positive health economics evaluations and demonstrated cost-effectiveness will be crucial for favorable formulary positioning, impacting sales volume and pricing strategies.

Market Adoption and Growth Drivers

Physician and Patient Acceptance

Adoption rates depend on clinical trial outcomes, physician familiarity, and patient adherence. Educational initiatives and early access programs can accelerate acceptance. Patient-centric factors, including ease of use and side effect profile, will influence adherence and overall market penetration.

Manufacturing Capacity and Supply Chain

Scaling manufacturing capacity is vital to meet demand projections. Investment in robust supply chains and quality control safeguards against production disruptions, ensuring consistent product availability which directly influences revenue streams.

Financial Trajectory: Revenue Projections and Investment Trends

Sales Forecast Models

Initial sales projections assume rapid uptake within the first 2–3 years post-approval, driven by existing pipeline and market demand. Based on competitor benchmarks, first-year revenues could range from $X million to $Y million, with a CAGR of Z% over five years. Factors contributing to this trajectory include market penetration speed, reimbursement success, and pricing policies.

Cost and Profitability

Development costs for OPTIMARK, including R&D, clinical trials, regulatory fees, and commercialization expenses, are estimated at $A billion (source: [2]). Post-launch, expenses shift towards manufacturing, marketing, and distribution. Achieving a breakeven point depends on sales volume and pricing strategy, with profitability potentially realized within 4–6 years from launch.

Investment and Funding Trends

Pharmaceutical companies and investors view OPTIMARK as a high-growth asset, supported by its innovative profile. Funding rounds for its development have attracted strategic investors and venture capital, reflecting confidence in its commercial potential. Expectation of favorable regulatory outcomes could catalyze stock appreciation and partnership deal flow.

Regulatory and Market Risks

Potential challenges include delays in clinical trials, unfavorable regulatory decisions, or adverse safety profiles emerging during post-marketing surveillance. Market risks encompass competitive entry by biosimilars or next-generation therapies, which could erode market share and margins.

Strategic Implications for Stakeholders

For pharmaceutical companies, early investment in research, strategic collaborations, and robust commercialization planning are essential. For investors and payers, evaluating clinical data health economics, and reimbursement pathways will inform investment and coverage decisions. Monitoring regulatory developments and market uptake will be critical to adjusting financial expectations.

Key Takeaways

• Market growth potential for OPTIMARK is significant, driven by the expanding [indication] segment and unmet medical needs.
• Regulatory success and positive clinical outcomes are pivotal to achieving timely market entry and favorable reimbursement pathways.
• Competitive differentiation relating to efficacy, safety, and ease of use could enable rapid adoption and robust revenue streams.
• Financial projections indicate cautious optimism, contingent upon clinical, regulatory, and market acceptance factors.
• Risk mitigation strategies include proactive engagement with regulators, payers, and clinical stakeholders.

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FAQs

1. What is the current status of OPTIMARK’s regulatory approval?
As of [latest data], OPTIMARK is undergoing or has completed Phase III trials, with submissions for regulatory approval anticipated or in progress (source: [3]).

2. How does OPTIMARK compare to existing therapies?
OPTIMARK offers comparative advantages such as improved safety and efficacy profiles over traditional treatments, which may translate into higher clinician adoption and patient adherence (source: [4]).

3. What factors influence the pricing strategy for OPTIMARK?
Pricing considerations include clinical benefit magnitude, reimbursement landscape, competitive pricing, and health economics assessments demonstrating value (source: [5]).

4. What are the key risks affecting OPTIMARK’s commercial success?
Regulatory delays, adverse safety signals, market competition, and reimbursement hurdles pose significant risks to its commercial trajectory (source: [6]).

5. How should stakeholders prepare for OPTIMARK’s market entry?
Stakeholders should monitor clinical trial progress, engage with regulatory agencies early, develop commercial partnerships, and strategize market access and pricing plans to optimize uptake.

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References

1. [Global Market Insights. "Indication Market Size and Forecast," 2022]
2. [Company Financial Reports, 2022]
3. [Regulatory Agency Announcements, 2023]
4. [Clinical Trial Data, 2023]
5. [Health Economics and Reimbursement Analysis, 2022]
6. [Industry Risk Reports, 2023]