GADAVIST Drug Patent Profile

When do Gadavist patents expire, and when can generic versions of Gadavist launch?

Gadavist is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in GADAVIST is gadobutrol. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the gadobutrol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gadavist

A generic version of GADAVIST was approved as gadobutrol by HENGRUI PHARMA on November 17^th, 2022.

Summary for GADAVIST

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	29
Patent Applications:	666
Drug Prices:	Drug price information for GADAVIST
What excipients (inactive ingredients) are in GADAVIST?	GADAVIST excipients list
DailyMed Link:	GADAVIST at DailyMed

See drug prices for GADAVIST

Recent Clinical Trials for GADAVIST

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

Sponsor	Phase
Brigham and Women's Hospital	NA
Lipella Pharmaceuticals, Inc.	Early Phase 1
Christopher J Chermansky, MD	Early Phase 1

See all GADAVIST clinical trials

Pharmacology for GADAVIST

Drug Class	Gadolinium-based Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity

US Patents and Regulatory Information for GADAVIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-006	Dec 18, 2013	AP	RX	Yes	Yes
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-003	Mar 14, 2011	AP	RX	Yes	Yes
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-001	Mar 14, 2011	AP	RX	Yes	Yes
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-002	Mar 14, 2011	AP	RX	Yes	Yes
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-005	Mar 14, 2011	AP	RX	Yes	Yes

Expired US Patents for GADAVIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-006	Dec 18, 2013	5,980,864
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-005	Mar 14, 2011	5,980,864
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-003	Mar 14, 2011	5,980,864
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-004	Mar 14, 2011	5,980,864
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-002	Mar 14, 2011	5,980,864

International Patents for GADAVIST

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

Country	Patent Number	Title	Estimated Expiration
Ireland	910902
Portugal	97065	PROCESSO PARA A PREPARACAO DE 1,4,7,1O-TETRAAZACICLODECANO-BUTILTROIS E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM
Hungary	910874
Austria	124405
European Patent Office	0448191	1,4,7,10-Tetraazacyclododécane-butyltriols, procédé pour leur préparation et agents pharmaceutiques les contenant. (1,4,7,10-Tetraazacyclododecane-butyltriols, process for their preparation, and pharmaceutical agents containing these compounds.)

Supplementary Protection Certificates for GADAVIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0448191	CA 2001 00009	Denmark

Market Dynamics and Financial Trajectory for GADAVIST

Last updated: July 28, 2025

Introduction

GADAVIST (gadofosveset trisodium) is a plasma volume expandable contrast agent primarily used in magnetic resonance angiography (MRA). Approved by the FDA in 2010, GADAVIST belongs to the class of gadolinium-based contrast agents (GBCAs), specifically designed for enhanced vascular imaging. Over recent years, the pharmaceutical landscape has seen evolving trends impacting the market prospects of GADAVIST, driven by technological advances, regulatory shifts, and competitive dynamics. This analysis examines the current market environment, key drivers, challenges, and the potential financial trajectory for GADAVIST in the coming years.

Market Overview and Current Position

GADAVIST's niche lies in high-resolution vascular imaging, particularly in detecting cerebrovascular abnormalities and peripheral vascular diseases. Its unique pharmacokinetic profile, including high relaxivity and blood-pool retention, enhances its appeal for detailed angiographic studies (source: [1]).

However, the overall GBCAs market faces challenges from increasing regulatory scrutiny over gadolinium deposition and adverse effects, prompting practitioners to balance diagnostic benefits with safety concerns (source: [2]). GADAVIST's distinct properties have maintained its relevance within a more conservative framework emphasizing safety, especially for patients requiring repeated imaging.

In 2022, the global GBCAs market was valued at approximately USD 2.2 billion, with high growth projected over the next decade (~ CAGR of 5%). Among these, macrocyclic agents like GADAVIST are gaining preferential attention for their stability and safety profiles (source: [3]).

Market Drivers

1. Rising Prevalence of Cardiovascular and Neurological Disorders

The global increase in cerebrovascular and peripheral arterial diseases directly correlates with higher demand for detailed vascular imaging. GADAVIST’s application in MRA makes it integral to diagnosis, especially for stroke, aneurysm, and vascular malformations.

2. Technological Advancements in Imaging Modalities

The integration of high-field MRI scanners has enhanced the resolution and diagnostic capabilities of contrast-enhanced angiography. GADAVIST’s high relaxivity complements these advancements, fostering increased adoption among radiologists seeking precise visualization.

3. Regulatory Environment Favoring Macrocyclic GBCAs

Recent regulatory guidelines have emphasized the safety profiles of MRI contrast agents. Macrocyclic GBCAs like GADAVIST are favored due to their decreased propensity for gadolinium retention and dissociation, aligning with stricter safety standards (source: [4]).

4. Growing Adoption in Emerging Markets

Economic development and increasing healthcare infrastructure investments in Asia-Pacific, Latin America, and the Middle East have expanded the customer base for high-end contrast agents, including GADAVIST. Market entry strategies targeting these regions are crucial for revenue expansion.

Market Challenges

1. Gadolinium Deposition and Safety Concerns

Growing evidence of gadolinium retention in brain tissue has prompted regulatory warnings and restrictions on certain GBCAs. While macrocyclic agents like GADAVIST show lower risks, ongoing safety concerns influence prescriber preferences and formulate cautious usage patterns, potentially limiting volume sales.

2. Competition from Other Contrast Agents

While GADAVIST maintains a niche due to safety, Bayer faces competition from other macrocyclic agents such as Clariscan (GE Healthcare) and Dotarem (Advanced MRI). Additionally, some institutions consider alternative imaging modalities like ultrasound or CT to circumvent GBCAs use altogether in certain cases.

3. Pricing Pressures and Healthcare Cost Containment

Payers and healthcare providers are increasingly focusing on cost-effective diagnostic options. The premium pricing of GADAVIST relative to generic or less expensive alternatives could constrain growth, especially in price-sensitive markets.

4. Digital and AI-Driven Imaging Technologies

Emerging AI-enhanced imaging algorithms aim to improve diagnostic accuracy without contrast agents, which could diminish reliance on injectables like GADAVIST over the long term.

Financial Trajectory

Short-Term Outlook (1-3 years)

The near-term financial outlook for GADAVIST remains cautiously optimistic. The continued global burden of cardiovascular and neurological diseases sustains steady demand. Bayer's strategic focus on expanding its high-value imaging portfolio, increased penetration in emerging markets, and regulatory endorsement of macrocyclic agents are positive signals.

However, growth may be tempered by regulatory cautiousness and market skepticism about long-term gadolinium safety, with potential impact from the gradual shift toward non-contrast imaging solutions. Bayer’s recent initiatives to improve supply chain efficiencies and clinical awareness campaigns could stimulate sales.

Medium to Long-Term Outlook (3-10 years)

Over the next decade, GADAVIST's market share could stabilize or slightly decline if safety concerns lead to reduced contrast agent usage, or if innovative imaging techniques supplant the need for gadolinium agents. Nonetheless, macrocyclic agents like GADAVIST are expected to retain a niche in complex vascular and neuroimaging, especially in high-end clinical settings.

Market forecasts suggest a compound annual growth rate (CAGR) of approximately 3-4% for GADAVIST, aligning with the broader macrocyclic GBCAs market. Revenue streams will likely depend on:

• Regulatory affordability and safety assurances
• Expansion into emerging markets
• Clinical evidence supporting superior safety profiles
• Strategic partnerships with hospitals and imaging service providers

Revenue Forecasts

Based on current market trends and Bayer’s portfolio strategies, GADAVIST’s revenues are projected to experience modest growth, with potential for increased adoption in neurovascular imaging owing to its high relaxivity. Any breakthroughs in alternative imaging, or adverse regulatory shifts, could significantly alter this trajectory.

Strategic Opportunities and Risks

Opportunities

• Pipeline Expansion: Development of next-gen contrast agents with improved safety and imaging efficacy.
• Market Penetration: Focused marketing in emerging markets where high-end contrast agents are still gaining traction.
• Clinical Evidence: Publishing large-scale studies demonstrating GADAVIST’s safety advantages to reinforce clinician confidence.
• Regulatory Advocacy: Engaging with health authorities to maintain favorable positioning for macrocyclic GBCAs.

Risks

• Regulatory Restrictions: Potential bans or usage restrictions if gadolinium deposition concerns escalate.
• Competitive Displacement: Preference shift toward non-contrast or alternative imaging technologies.
• Pricing Pressures: Increased competition leading to price erosion compromising margins.
• Market Saturation: Mature markets with limited incremental growth.

Conclusion

GADAVIST occupies a specialized segment within the GBCAs landscape, benefiting from safety features and technological compatibility with advanced MRI systems. Its financial trajectory hinges on evolving safety perceptions, regulatory frameworks, and technological progress. Moderate growth over the next decade appears feasible, contingent on strategic positioning, demonstration of safety superiority, and expansion into emerging markets. However, it must navigate the broader threats posed by technological innovation and shifting clinical preferences.

Key Takeaways

• GADAVIST remains relevant due to its safety profile and high relaxivity in vascular imaging.
• Market growth is supported by rising healthcare needs and technological advances but constrained by safety concerns and competition.
• Regulatory emphasis on gadolinium safety favors macrocyclic contrast agents like GADAVIST.
• Emerging markets present significant growth opportunities, provided Bayer adapts its market access strategies.
• Long-term prospects depend on innovation, clinical evidence, and the ability to navigate regulatory and technological shifts.

FAQs

1. How does GADAVIST differentiate itself from other gadolinium-based contrast agents?
GADAVIST’s key differentiator is its high relaxivity and blood-pool retention, offering superior vascular imaging, particularly in neuro and peripheral angiography, combined with a favorable safety profile due to its macrocyclic structure.

2. What are the regulatory challenges facing GADAVIST?
Recent warnings about gadolinium retention and deposition in tissues have led to stricter guidelines, especially in Europe and North America, which could impact its use and reimbursement policies.

3. Which markets offer the greatest growth potential for GADAVIST?
Emerging markets in Asia-Pacific, Latin America, and the Middle East offer substantial growth opportunities due to expanding healthcare infrastructure and increasing demand for advanced imaging modalities.

4. How might innovations in imaging technology impact GADAVIST’s market share?
Advances such as AI-enhanced non-contrast imaging protocols could reduce reliance on contrast agents, challenging the growth of contrast-dependent agents like GADAVIST.

5. What strategic actions can Bayer take to sustain GADAVIST’s market position?
Bayer can focus on clinical research demonstrating safety advantages, expand into high-growth regions, collaborate with healthcare providers, and invest in next-generation contrast agent development to maintain competitive edge.

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Sources:
[1] Bayer. GADAVIST Product Information.
[2] FDA Drug Safety Communications. Gadolinium-based contrast agents.
[3] MarketsandMarkets. Contrast Agents Market Report, 2022.
[4] European Medicines Agency. Gadolinium-containing contrast agents safety review.