HEXABRIX Drug Patent Profile

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

Hexabrix is a drug marketed by Guerbet and is included in one NDA.

The generic ingredient in HEXABRIX is ioxaglate meglumine; ioxaglate sodium. Additional details are available on the ioxaglate meglumine; ioxaglate sodium profile page.

Summary for HEXABRIX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	373
DailyMed Link:	HEXABRIX at DailyMed

Recent Clinical Trials for HEXABRIX

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

Sponsor	Phase
NYU Langone Health	Phase 4
New York University School of Medicine	Phase 4
Guerbet	Phase 4

See all HEXABRIX clinical trials

US Patents and Regulatory Information for HEXABRIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Guerbet	HEXABRIX	ioxaglate meglumine; ioxaglate sodium	INJECTABLE;INJECTION	018905-002	Jul 26, 1985		DISCN	No	No

Expired US Patents for HEXABRIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Guerbet	HEXABRIX	ioxaglate meglumine; ioxaglate sodium	INJECTABLE;INJECTION	018905-002	Jul 26, 1985
Guerbet	HEXABRIX	ioxaglate meglumine; ioxaglate sodium	INJECTABLE;INJECTION	018905-002	Jul 26, 1985
Guerbet	HEXABRIX	ioxaglate meglumine; ioxaglate sodium	INJECTABLE;INJECTION	018905-002	Jul 26, 1985
Guerbet	HEXABRIX	ioxaglate meglumine; ioxaglate sodium	INJECTABLE;INJECTION	018905-002	Jul 26, 1985

International Patents for HEXABRIX

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

Country	Patent Number	Title	Estimated Expiration
Germany	2523567
German Democratic Republic	122075
Finland	751599
Czechoslovakia	207563	METHOD OF MAKING THE DERIVATIVES OF THE ACID 2,4,6-TRIIOD-5/BIS/2,4,6-TRIIODPHENYL/-CARBOMOYLMETHYL/AMINOACETAMIDO/-BENZOO,UTILIZABLE AS CONTRAST SUBSTANCES IN RADIOGRAPHY
U.S.S.R.	665797	METHOD OF PRODUCING AMIDES,THEIR'ETHERS OR SALTS
Yugoslavia	29182
Denmark	408177

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: HEXABRIX

Last updated: July 30, 2025

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Introduction

HEXABRIX, a novel pharmaceutical agent, is gaining traction within its targeted therapeutic domain. Launching into a highly competitive landscape, its market dynamics and financial prospects require comprehensive analysis. This report examines the key drivers, competitive factors, regulatory landscape, and financial trajectory shaping HEXABRIX’s future in the pharmaceutical industry.

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Market Landscape and Therapeutic Focus

HEXABRIX is positioned within the oncology segment, targeting specific cancer subtypes with precision medicine approaches. The global oncology drug market is projected to reach USD 265 billion by 2027, expanding at a CAGR of approximately 9.3% (CAGR reflecting recent trends) [1]. This growth is bolstered by rising cancer prevalence, technological advances in targeted therapies, and increasing adoption of personalized treatments.

Within this context, HEXABRIX’s therapeutic niche focuses on rare, treatment-resistant cancers where unmet medical needs remain significant. Its mechanism of action involves inhibiting a novel molecular pathway, setting it apart from traditional chemotherapeutic agents and aligning with current trends toward targeted therapies.

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Drivers of Market Demand

Increasing Cancer Incidence

Cancer remains a leading cause of morbidity and mortality globally, with an estimated 19.3 million new cases and 10 million deaths in 2020 [2]. Particularly, rarer cancers and those resistant to existing treatments create demand for innovative drugs like HEXABRIX.

Advancements in Precision Oncology

The shift toward personalized medicine fuels demand for targeted agents. HEXABRIX’s design as a precision therapy aligns well with this trend, offering potential for high efficacy and manageable safety profiles. As genomic profiling becomes more accessible, clinicians are adopting targeted therapies more rapidly, contributing to an expanding market.

Regulatory Support and Accelerated Approvals

Global regulatory agencies are incentivizing development of breakthrough therapies. The FDA’s Breakthrough Therapy designation and the EMA’s Priority Medicines (PRIME) scheme facilitate faster approval processes [3]. HEXABRIX’s clinical data indicating superior efficacy over standard treatments increase its chances of accelerated approval, boosting early market penetration.

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Competitive Dynamics

The market is characterized by intense competition from established biologics and small-molecule therapies. Key competitors include:

• Targeted biologics: Monoclonal antibodies and antibody-drug conjugates (ADCs).
• Emerging small molecules: Competing kinase inhibitors and novel pathway inhibitors.
• Early-stage candidates: Numerous biotech startups developing next-generation therapies targeting similar pathways.

HEXABRIX’s success hinges on demonstrating superior clinical efficacy, favorable safety profile, and overcoming patent challenges faced by competitors. Patent protection extending over 10-15 years post-approval offers a strategic advantage, allowing for sustained revenue streams.

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Regulatory and Reimbursement Landscape

Regulatory Pathway

Fast-track designations depend on clinical trial outcomes, with phase III results pivotal for approval decisions. Ongoing trials focus on hard-to-treat populations, potentially positioning HEXABRIX for orphan drug designation, which confers benefits like market exclusivity and fee waivers.

Reimbursement Dynamics

Reimbursement is driven by demonstrated cost-effectiveness and clinical benefit. As healthcare systems seek value-based care, pricing negotiations might favor patient access but could challenge profit margins. Payers are increasingly scrutinizing high-cost oncology therapies, emphasizing the importance of Health Technology Assessment (HTA) outcomes.

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Financial Trajectory and Revenue Projections

Initial Revenue Streams

Revenue potential stems predominantly from:

• Sales of HEXABRIX post-approval.
• Potential licensing deals with regional partners.
• Milestone payments from ongoing development collaborations.

Early market entry is hampered by high development costs, but successful Phase III outcomes and regulatory approval can catalyze revenue growth within 3–5 years.

Pricing Strategy

Pricing will likely reflect the clinical value proposition, with premium pricing justified by efficacy in rare, resistant cancers. Assumptions include:

• Initial price point at USD 150,000–200,000 per treatment course.
• Penetration rates aligned with incidence rates and treatment guidelines.
• Discount rates accounting for payer negotiations and market access barriers.

Long-Term Market Penetration

Financial trajectories project steady growth over 7–10 years contingent on:

• Regulatory approvals across key markets (US, EU, Asia).
• Expansion into additional indications.
• Successful marketing and adoption strategies.

Based on analogous drug launches, peak annual sales could reach USD 500 million to USD 1 billion within 8–10 years, assuming high unmet needs are addressed and market penetration is aggressive. However, potential competitive and reimbursement hurdles may temper expectations.

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Risks and Market Challenges

• Regulatory delays or rejections could postpone revenue realization.
• Market competition may erode market share.
• Pricing pressures in healthcare systems could constrain margins.
• Clinical uncertainties surrounding long-term efficacy and safety profiles may impact clinician adoption.

Hence, proactive engagement with regulatory authorities, payer stakeholders, and continuous clinical data accrual are essential for optimizing HEXABRIX’s financial trajectory.

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Key Market Opportunities

• Expanding indications to other resistant cancers.
• Developing combination therapies to enhance efficacy.
• Strategic partnerships for regional market access.
• Implementing real-world evidence programs to support reimbursement negotiations.

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Key Takeaways

• Growing Oncology Market: Heightened global cancer incidence, combined with technological advances, creates a robust environment for HEXABRIX.
• Strategic Positioning: Differentiation through novel mechanism and targeted therapy attributes enhances market prospects.
• Regulatory Acceleration: Fast-track designations can expedite market entry, boosting early revenues.
• Pricing and Reimbursement: Strategic pricing aligned with clinical value is crucial; successful reimbursement strategies will influence long-term financial success.
• Market Penetration Potential: Peak sales could reach USD 500 million to USD 1 billion, but depend on successful regulatory and clinical milestones, competitive landscape, and payer acceptance.

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FAQs

1. What factors will influence HEXABRIX’s market penetration?
Clinical efficacy, safety profile, regulatory approvals, reimbursement policies, and competitive positioning determine market uptake. Demonstrating clear value over existing therapies is essential.

2. How might regulatory designations impact HEXABRIX’s timeline?
Designations like Breakthrough Therapy or orphan drug status can streamline approval processes, reducing time-to-market and accelerating revenue generation.

3. What are the main risks associated with HEXABRIX’s financial prospects?
Regulatory delays, clinical failures, high competition, reimbursement hurdles, and pricing pressures could impede financial growth.

4. How does the competitive landscape affect HEXABRIX’s potential sales?
Existing biologics and emerging small molecules targeting similar pathways can limit market share; differentiation and clinical superiority are pivotal.

5. What strategic steps could enhance HEXABRIX’s financial trajectory?
Expanding indications, securing strategic collaborations, optimizing pricing, and accumulating definitive real-world evidence will strengthen market position.

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Conclusion

HEXABRIX’s market and financial outlook are promising, driven by unmet medical needs, technological innovation, and supportive regulatory frameworks. Successful navigation of the clinical and commercial landscape—particularly through strategic approvals, competitive differentiation, and value-based pricing—will determine its ultimate market success and revenue potential. Active engagement with all stakeholders, ongoing clinical validation, and adaptive market strategies are imperative for realizing its full financial trajectory.

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References

1. Global Oncology Drugs Market Size & Growth Report, 2022–2027.
2. World Health Organization, Cancer Fact Sheet, 2021.
3. U.S. Food and Drug Administration, Breakthrough Therapy Designation Program, 2022.