PROHANCE Drug Patent Profile

Which patents cover Prohance, and when can generic versions of Prohance launch?

Prohance is a drug marketed by Bracco and is included in two NDAs.

The generic ingredient in PROHANCE is gadoteridol. Two suppliers are listed for this compound. Additional details are available on the gadoteridol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prohance

A generic version of PROHANCE was approved as gadoteridol by HAINAN POLY on February 11^th, 2025.

Summary for PROHANCE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	9
Patent Applications:	1,021
Drug Prices:	Drug price information for PROHANCE
What excipients (inactive ingredients) are in PROHANCE?	PROHANCE excipients list
DailyMed Link:	PROHANCE at DailyMed

See drug prices for PROHANCE

Recent Clinical Trials for PROHANCE

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

Sponsor	Phase
University of Alabama at Birmingham	Early Phase 1
University of Alabama at Birmingham	Phase 1
Guerbet	Phase 4

See all PROHANCE clinical trials

Pharmacology for PROHANCE

Drug Class	Paramagnetic Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity

US Patents and Regulatory Information for PROHANCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992	AP	RX	Yes	Yes
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003		RX	Yes	Yes

Expired US Patents for PROHANCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992

International Patents for PROHANCE

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

Country	Patent Number	Title	Estimated Expiration
Canada	1296715	1-(SUBSTITUANT)-1,4,7-TRIS(CARBOXYMETHYL)-1,4,7,10- TETRAAZACYCLODODECANE ET COMPOSES ANALOGUES (1-SUBSTITUTED-1,4,7-TRISCARBOXYMETHYL-1,4,7,10- TETRAAZACYCLODODECANE AND ANALOGS)
European Patent Office	0292689	1,4,7-Triscarboxyméthyl-1,4,7,10-tétraazacyclododécane substitué et analogues (Substituted 1,4,7-triscarboxymethyl-1,4,7,10-tetraazacyclo-dodecane and analogs)
Japan	S62190175	1-SUBSTITUTED-1,4,7-TRISCARBOXYMETHYL-1,4,7,10- TETRAAZACYCLODODECANE AND ANALOGUE
Mexico	174467	1,4,7-TRISCARBOXIMETIL-1,4,7,10-TETRAAZACICLODO DECANO SUBSTITUIDO EN 1 Y COMPUESTOS ANALOGOS
Germany	3772785
Germany	3855451
European Patent Office	0232751	1-SUBSTITUTED-4,7,10-TRISCARBOXYMETHYL-1,4,7,10-TETRAAZACYCLODODECANE AND ANALOGS

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PROHANCE

Last updated: July 30, 2025

Introduction

PROHANCE (gadoteridol) is an iodinated contrast agent developed by Bracco Imaging for use in magnetic resonance imaging (MRI). Approved by the FDA for detecting and delineating brain, spine, and joint pathologies, PROHANCE’s clinical efficacy, safety profile, and market positioning significantly influence its commercial trajectory. This analysis explores the intricate market forces, regulatory landscape, technological trends, competitive environment, and financial prospects shaping PROHANCE’s market landscape.

Market Overview

The global contrast agent market, valued at approximately USD 4.9 billion in 2022 [1], exhibits robust growth driven by increasing prevalence of neurological, oncological, and cardiovascular diseases, and rising adoption of advanced imaging techniques. MRI contrast agents account for around 65% of this market, with gadolinium-based agents like PROHANCE representing a substantial share.

The MRI contrast agent market has seen steady expansion, propelled by technological innovations, broader clinical applications, and regulatory approvals. Notably, the rising incidence of Alzheimer’s disease, strokes, and cancer bolsters demand for high-resolution imaging, indirectly supporting products like PROHANCE.

Market Dynamics

1. Regulatory and Safety Considerations

The safety profile of gadolinium-based contrast agents (GBCAs) influences market dynamics. Concerns regarding gadolinium accumulation in tissues and rare adverse events historically prompted regulatory agencies to implement stricter guidelines. The European Medicines Agency (EMA) and FDA have issued bans or restrictions on certain linear GBCAs due to nephrogenic systemic fibrosis (NSF) and gadolinium deposition [2].

PROHANCE, as a macrocyclic agent with a proven safety profile, benefits from these regulatory shifts favoring more stable formulations. The agent's low chelate dissociation reduces deposition risks, reinforcing its preference in clinical practice.

2. Competitive Landscape

The MRI contrast agent landscape is highly competitive, featuring several key players:

• Bracco's PROHANCE
• GE Healthcare's Omniscan (gadodiamide)
• Bracco's imaging agents for high-relaxivity agents
• Respective biosimilars or generics with similar efficacy

While PROHANCE maintains a competitive edge via proven safety metrics, its market share faces competition from newer, higher-relaxivity agents offering enhanced imaging contrast or reduced dosage requirements.

3. Technological Advancements

Emerging MRI techniques like higher field strength imaging (7 Tesla and above) demand contrast agents with optimized relaxivity. PROHANCE’s high relaxivity at clinical field strengths makes it adaptable, but novel agents with advanced molecular structures could challenge its dominance.

Additionally, the development of other contrast modalities, such as iron oxide nanoparticles or targeted molecular agents, could alter the traditional contrast agent landscape.

4. Clinical Adoption Trends

Increased use of contrast-enhanced MRI for neurological and oncological imaging sustains demand for agents like PROHANCE. The shift toward more precise, high-resolution diagnostics amplifies the need for reliable contrast agents.

However, caution over gadolinium retention has led some clinicians to favor non-contrast MRI protocols or alternative agents, slightly curbing growth. Nonetheless, PROHANCE's favorable safety profile supports continued clinical integration.

5. Pricing and Reimbursement Policies

Pricing strategies and reimbursement policies significantly influence sales volume. Typically, contrast agents are reimbursed based on standardized codes; however, escalating healthcare costs drive preference for cost-effective agents.

PROHANCE’s recommended pricing aligns with its safety and efficacy, but market penetration depends on healthcare providers’ reimbursement dynamics and competition.

Financial Trajectory

1. Revenue Trends

Historically, PROHANCE’s revenues have exhibited stable growth patterns aligned with overall market expansion. According to Bracco's financial disclosures, contrast agents contribute notably to its specialty portfolio, with steady demand across North America, Europe, and Asia.

The COVID-19 pandemic temporarily disrupted elective imaging procedures, causing revenue dips. Nevertheless, as healthcare systems recover, projection models anticipate rebounding and sustained growth.

2. Market Expansion Opportunities

Emerging markets in Asia-Pacific represent substantial growth opportunities due to expanding healthcare infrastructure and increasing disease prevalence. Increased investment in MRI infrastructure and raising awareness about advanced imaging will further stimulate demand.

Bracco's strategic investments and partnerships in these regions bolster PROHANCE’s revenue prospects.

3. Potential Patent Expirations and Generics

PROHANCE’s patent protections are crucial for maintaining premium pricing. While its core patent protections have largely expired or are near their expiry, secondary patents and formulation advantages offer some market exclusivity.

The entry of generic versions would pressure pricing and profit margins, but PROHANCE’s established reputation and safety profile may bolster brand loyalty, mitigating immediate volume loss.

4. R&D and New Formulations

Investments in formulation improvements and novel delivery mechanisms can prolong market relevance. A focus on lower-dose formulations with comparable or superior efficacy and safety profiles can broaden clinical adoption and revenue streams.

5. Competitive and Regulatory Risks

Potential regulatory setbacks, particularly regarding gadolinium retention concerns, could lead to restricted use or market withdrawal, impacting revenue. Conversely, favorable regulations will support sustained sales growth.

Market Outlook

Projections suggest that the global MRI contrast agent market will continue its compound annual growth rate (CAGR) of approximately 4-6% through 2030 [1]. PROHANCE, positioned as a macrocyclic gadolinium-based agent, is well-placed to capitalize on this trend due to its established safety profile and versatility.

Growth is driven by increasing diagnostic imaging needs, technological innovations in MRI, and expanding clinical indications. Market share gains for PROHANCE depend on ongoing safety reassurance, updates aligning with technological trends, and strategic geographic expansion.

Key Factors Influencing Future Financial Trajectory

• Regulatory environment: Stricter safety standards may favor safer agents like PROHANCE.
• Innovation: Development of new formulations or combinations can offer differentiated offerings.
• Regional penetration: Expanding presence in emerging markets can substantially boost revenues.
• Competitive product launches: New contrast agents with superior relaxivity or targeted capabilities pose a threat.
• Pricing strategies: Balancing cost-effectiveness with profitability remains vital.

Key Takeaways

• PROHANCE remains a vital player in the gadolinium-based MRI contrast agent market, supported by a strong safety profile and clinical versatility.
• Market dynamics favor macrocyclic agents, making PROHANCE well-positioned amid evolving safety regulations concerning linear GBCAs.
• Ongoing technological advances and regional expansion present tangible growth opportunities, especially in Asia-Pacific.
• Competitive pressures and potential regulatory restrictions necessitate continuous R&D and strategic positioning.
• The financial outlook is optimistic, hinging on market expansion, innovation, and regulatory stability, with global CAGR projected at 4-6% through 2030.

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FAQs

1. How does PROHANCE differentiate itself from other gadolinium-based contrast agents?
PROHANCE’s macrocyclic structure confers a higher stability, reducing gadolinium release and associated risks such as NSF or gadolinium retention, compared to linear agents, giving it a safety advantage.

2. What are the primary factors driving demand for MRI contrast agents like PROHANCE?
Increasing prevalence of chronic diseases, technological advances in MRI, and expanding indications for contrast-enhanced imaging underpin rising demand.

3. How might regulatory changes impact PROHANCE’s market share?
Stricter regulations on linear GBCAs favor macrocyclic agents like PROHANCE, potentially enhancing its market share, provided it maintains compliance and safety standards.

4. What regional markets offer the greatest growth potential for PROHANCE?
Emerging markets in Asia-Pacific, driven by expanding healthcare infrastructure and increasing disease burden, provide significant growth opportunities for PROHANCE.

5. How does the introduction of new contrast agents influence PROHANCE’s future?
Innovations with higher relaxivity, targeted imaging features, or novel mechanisms could challenge PROHANCE’s market position; however, branding and proven safety profiles help sustain its relevance.

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References

1. Grand View Research, "Contrast Agents Market Size, Share & Trends Analysis Report," 2022.
2. European Medicines Agency, "Gadolinium-containing contrast agents: safety updates," 2022.