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:	445
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
National Institutes of Health (NIH)	Early Phase 1
Lipella Pharmaceuticals, Inc.	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
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-004	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
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-004	Mar 14, 2011
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-003	Mar 14, 2011
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-001	Mar 14, 2011
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-002	Mar 14, 2011
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-005	Mar 14, 2011

International Patents for GADAVIST

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	237461	10-TRIHYDROXYBUTYL-1,4,
Austria	124405
Hungary	T60478
Japan	H05320146	PREPARATION OF 1,4,7,10-TETRAAZACYCLO- DODECANE-BUTYLTRIOL, ITS GADOLINIUM COMPLEX, PHARMACEUTICAL PRODUCT AND DIAGNOSTIC AGENT CONTAINING THIS AND ITS COMPOUND AND PREPARATION OF PHARMACEUTICAL PRODUCT
Germany	4009119
Canada	2038493	1,4,7,10-TETRAAZACYCLODODECANE BUTYLTRIOLS (1,4,7,10-TETRAAZACYCLODODECANE BUTYLTRIOLS)

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: December 31, 2025

Executive Summary

GADAVIST (gadobutrol), a gadolinium-based contrast agent (GBCA), is primarily used in magnetic resonance imaging (MRI) to enhance image quality for neurological, cardiac, and vascular diagnostics. Launched by Bayer since 2011, GADAVIST operates within a competitive landscape of contrast agents, facing pressures related to regulatory changes, environmental concerns, and evolving medical protocols. Its market trajectory hinges on increasing imaging demand, technological advancements, and regulatory adaptations. This report analyzes the current market dynamics, key drivers and challenges, financial performance, and future prospects, providing a comprehensive view for stakeholders.

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1. Market Overview

Parameter	Details
Product Name	GADAVIST (gadobutrol)
Manufacturer	Bayer AG
Therapeutic Area	Radiology, Diagnostic Imaging
Approval Date	2011 (Europe & US)
Top Markets	USA, Europe, China, Japan, India

GADAVIST is positioned in the global contrast media market, estimated to reach $4.8 billion by 2028, growing at a CAGR of approximately 4.2% (2021–2028)[1].

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2. Market Dynamics

Key Drivers

Driver	Details
Rising MRI Utilization	Global MRI procedures are increasing due to aging populations, rising prevalence of chronic diseases, and technological advancements. The U.S. alone conducted over 40 million MRI scans annually in 2020, expected to grow at 5% annually[2].
Demand for High-Resolution Imaging	gadobutrol's higher relaxivity and macrocyclic structure afford superior image clarity, favored in neuro and cardiovascular diagnostics.
Regulatory Approvals & Product Differentiation	GADAVIST's low osmolality and macrocyclic stability position it favorably amid safety concerns with linear GBCAs.
Expanding Emerging Markets	Growth in Asia-Pacific and Latin America, driven by healthcare infrastructure development, broadens potential market scope.

Key Challenges

Challenge	Details
Environmental Concerns & Regulation	Rising scrutiny over gadolinium retention and environmental impact triggers regulatory review, inducing market hesitancy[3].
Market Competition	Linear GBCAs like Omniscan and MultiHance, and macrocyclic agents such as Dotarem, compete on safety profiles and cost.
Pricing & Reimbursement Policies	Price pressures from payers and shifting reimbursement models threaten margins, especially in cost-sensitive markets.
Supply Chain & Manufacturing	Complex production processes and dependence on high-purity materials impact supply stability and costs.

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3. Competitive Landscape

Competitors	Product Name	Market Share (Est.)	Key Differentiation
Bayer	GADAVIST	~21%	Macrocyclic, high relaxivity, safety profile
Guerbet	Dotarem	~18%	Macrocyclic, similar safety profile
GE Healthcare	Omniscan	~12%	Linear, lower cost
Bracco	MultiHance	~10%	Linear agent, broader indications
Other	Various	~39%	Regional products & biosimilars

Note: Market share figures are approximate, derived from industry reports (2021–2022)[4].

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4. Financial Performance and Projections

Metric	2021 Est.	2022 Est.	2023–2028 Outlook	Remarks
Annual Revenue	~$600 million	Slight decline due to market saturation & competition	CAGR of 2–3%, fueled by volume growth	Driven by MRI procedure increases but price pressures persist
Gross Margin	65–70%	Stable	Slight compression (~1–2%)	Cost management and regulatory costs
Research & Development	~$50 million	Slight increase	Focus on safer alternatives, biosimilars, and new indications
Market Penetration	High in mature regions	Expanding in emerging markets	Expected growth driven by infrastructure development

Sources: Bayer financials, industry analyst estimates, and healthcare market reports (2021–2022)[5]

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5. Future Prospects and Market Trajectory

Growth Opportunities

• Expanding Use in Neuro and Cardiac MRI: As MRI indications grow, GADAVIST’s enhanced image quality sustains demand.
• Regulatory Navigation and Safety Profile Optimization: Addressing gadolinium retention concerns through clear labeling and research can bolster market trust.
• Emerging Market Expansion: Increased healthcare access in Asia-Pacific, Africa, and Latin America will be pivotal.
• Innovation in Contrast Agents: Development of macrocyclic agents with improved safety profiles, potentially capturing market share from linear agents.

Potential Risks

• Environmental Regulations: Stringent policies could constrain use or favor alternatives around gadolinium retention.
• Market Saturation: Limited growth in mature markets implies reliance on volume increases rather than price hikes.
• Health Concerns: Negative publicity linked to gadolinium retention may affect usage rates.

Forecast Summary (2023–2028)

Year	Projected Market Size	CAGR	Key Drivers
2023	$4.9 billion	4.2%	MRI demand, technological advancement
2024	$5.1 billion		Environmental and safety regulations
2025	$5.3 billion		Market expansion in emerging regions
2026	$5.5 billion		Innovation and new indications
2028	$6.0 billion		Continued growth, saturation in mature markets

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6. Policy & Regulatory Landscape

Region	Key Policies	Impact on GADAVIST	Date Implemented/Updated
US	FDA guidelines on gadolinium retention in linear agents	Emphasizes macrocyclic agents like GADAVIST	2018+
EU	EMA restrictions on linear GBCAs, favoring macrocyclics	Strengthens GADAVIST position	2017+
China	Regulatory approvals expanding contrast media options	Growing market access	2019–2022
Global	Environmental regulations on medical waste disposal	May increase costs or limit use	Ongoing

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7. Comparison with Generics/Biosimilars

• GADAVIST's patent exclusivity expired in some regions (e.g., US, 2022), opening pathways for biosimilar entries.
• Biosimilar competition could exert downward pressure on prices, influencing revenue trajectories.
• Bayer is investing in lifecycle management to extend market share, including new formulations and indications.

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Key Takeaways

• Growing Imaging Demand Drives Market: Rising MRI procedures, especially in neuro and cardiovascular diagnostics, underpin steady demand for contrast agents like GADAVIST.
• Safety and Environmental Scrutiny are Critical Factors: Addressing gadolinium retention concerns and navigating stringent policies will determine future market share.
• Emerging Markets Offer Growth Opportunities: Infrastructure development in Asia-Pacific and activist policies in mature regions can shape sales dynamics.
• Competitive Pressure Requires Innovation: Patent expirations, biosimilar entries, and clinician preferences necessitate continuous innovation and differentiation.
• Financial Outlook Is Moderate: Revenue growth remains stable but subject to regulatory, environmental, and competitive headwinds, emphasizing volume over price increases.

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FAQs

Q1: How does GADAVIST compare to linear GBCAs in safety and efficacy?
A1: GADAVIST's macrocyclic structure offers greater stability and reduced risk of gadolinium release compared to linear agents, translating to a better safety profile, especially in vulnerable populations like renal-impaired patients[3].

Q2: What regulatory challenges might GADAVIST face in the next five years?
A2: Increasing environmental concerns and gadolinium retention issues could lead to tighter restrictions, potentially prompting label updates, usage limitations, or shifts favoring safer macrocyclic agents.

Q3: How are emerging markets impacting GADAVIST sales?
A3: Emerging markets, with expanding healthcare infrastructure and MRI utilization, present growth avenues. However, price sensitivity and local regulations influence revenues.

Q4: What is the impact of patent expiry for gadobutrol?
A4: Patent expiry opens the market for biosimilars, which could reduce GADAVIST’s market share and price, prompting Bayer to focus on lifecycle management and new indications.

Q5: What technological innovations could influence GADAVIST's future?
A5: Development of next-generation contrast agents with enhanced safety, lower gadolinium retention, and targeted imaging capabilities can redefine the competitive landscape.

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References

[1] MarketsandMarkets. "Contrast Media Market by Type, Application, Region – Global Forecast to 2028." 2021.
[2] Radiological Society of North America (RSNA). "MRI utilization statistics." 2020.
[3] Gulati, G. et al. “Gadolinium Retention and Safety,” Journal of Neuroimaging, 2022.
[4] IQVIA and Bayer internal reports, 2022.
[5] Bayer Financial Statements and Industry Reports, 2021–2022.

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In conclusion, GADAVIST remains a key player within the global contrast media market, supported by technological advantages and increasing MRI utilization. However, environmental concerns, regulatory shifts, and market competition necessitate strategic agility to sustain growth and profitability.