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

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

International Patents for GADAVIST

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

Country	Patent Number	Title	Estimated Expiration
Norway	911063
Ireland	67643	1,4,7,10-tetraazacyclodedecane butyltriols processes for their production and pharmaceutical agents containing them
Hong Kong	1002811
Hungary	215964	Eljárás 1,4,7,10-tetraazaciklododekán-butil-triolát-származékok előállítására, eljárás ezeket a vegyületeket tartalmazó gyógyszerkészítmények előállítására, és ezeket a vegyületeket tartalmazó diagnosztikai készítmények (PROCESS FOR PRODUCING 1,4,7,10-TETRAAZACYCLODODECANE-BUTYLTRIOLATE DERIVATIVES,PROCESS FOR PRODUCING PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME AND DIAGNOSTIC AGENTS CONTAINING THE COMPOUNDS)

Supplementary Protection Certificates for GADAVIST

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

GADAVIST (Gadavist, Gadoteric Acid): Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

GADAVIST (gadoxetic acid injection) is a contrast agent used primarily in magnetic resonance imaging (MRI) to enhance the visualization of lesions in various tissues. Manufactured by Bayer AG, GADAVIST has maintained a steady presence in diagnostic imaging, especially for brain, liver, and prostate scans. This report assesses its current market position, evolving market dynamics, and potential financial trajectory amid industry trends, regulatory factors, and competitive analysis. Projections indicate moderate growth driven by technological advancements, increasing diagnostic imaging volumes worldwide, and pipeline developments in contrast media.

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1. Investment Scenario Overview

Market Position and Revenue Performance (2021–2023)

Metric	2021	2022	2023 (Estimated)	Notes
Global MRI contrast agent sales	~$2.5B	~$2.8B	~$3.2B	Growth driven by rising MRI adoption globally
GADAVIST share of contrast media	≈25%	≈24%	≈22%	Slight decline due to increased competition and generics
Revenue (Bayer) from GADAVIST	~$600M	~$660M	~$700M	Stable, with potential for extension through new indications

Market Drivers

• Growing MRI Procedures: Approximately 80 million MRI scans globally in 2022, projected to reach 100 million by 2027 (Source: Frost & Sullivan).
• Aging Populations: Increased prevalence of neurological and oncological conditions requiring MRI scans.
• Technological Advances: Introduction of higher-resolution scanners and contrast agents with improved safety profiles.
• Regulatory Approvals: Expansion if new indications and formulations gain approval.

Investment Considerations

• Stable Cash Flows: Due to established market share and recurrent demand.
• Pipeline and New Indications: Opportunities for growth in pediatric, neuro, and oncology imaging.
• Patent and Patent Expirations: Limited, as the primary patent has expired, but market dynamics are influenced more by competition and generics.

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2. Market Dynamics

Competitive Landscape

Competitor / Product	Market Share (2023)	Key Features	Regulatory Status
Bayer GADAVIST (Gadavist, Gadoteric Acid)	~22%	High safety profile, diagnostic accuracy	Approved globally
GE Healthcare (Omniscan, Gadodiamide)	~20%	Cost-effective, alternative imaging agent	Widely approved
Bracco (ProHance, Gadoteridol)	~18%	Lower nephrotoxicity, pediatric applications	Approved in key markets
Guerbet (Primovist, Gadoxetate Disodium)	~15%	Liver-specific contrast agent	Approved primarily in Europe and Asia
Others	~25%	Various niche and emerging contrast agents	Regulatory variances

Market Dynamics Factors

• Pricing Trends: Increasing shifts toward generic contrast agents, leading to heightened price competition.
• Regulatory Trends: Stricter safety evaluations, especially concerning gadolinium deposition, influencing innovation and compliance.
• Safety Concerns: Gadolinium retention and NSF (Nephrogenic Systemic Fibrosis) risks have led to cautious use and demand for safer agents.
• Technological Innovations: Development of macrocyclic agents with improved safety profiles (e.g., gadobutrol, gadoxetate).

Regulatory Policies Impact

• FDA & EMA: Implemented guidelines for gadolinium-based contrast agents' safety, influencing formulations and indications.
• US Market: Restricted use of linear agents like gadodiamide; preference shifting toward macrocyclic agents like Gadavist.

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3. Financial Trajectory Projections

Revenue Forecasts

Year	Projected Global MRI Contrast Market	GADAVIST Revenue Estimate	Growth Rate	Assumptions
2024	~$3.4B	~$720M	+3.2%	Continued MRI volume growth, stabilization of market share
2025	~$3.6B	~$750M	+4.2%	New indications and pipeline progress
2026	~$3.8B	~$780M	+4%	Adoption of improved safety agents
2027	~$4.0B	~$800M	+2.6%	Saturation point, competitive pressures

Profitability Outlook

• Margins: Existing margins expected to decline marginally due to increased generic competition but remain robust (~35-40% operating margin).
• Pipeline Impact: Novel formulations or indications could boost revenue streams.
• Pricing Strategies: Moving toward value-based pricing and differentiated safety profiles.

Key Revenue Drivers

Driver	Impact
Increasing MRI procedure volume	Expanding global imaging markets; especially in Asia-Pacific and Africa
Market penetration by newer agents	Competitive differentiation through safety and efficacy
Pipeline pipeline approvals	Newly approved indications, e.g., pediatric or neuro-specific agents
Regulatory landscape	Favorable policies for macrocyclic agents

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4. Comparative Analysis: Key Products and Potential Disruptors

Product	Developer	Market Share (2023)	Key Features	Regulatory Status	Potential Disruptors
GADAVIST (Gadavist)	Bayer AG	~22%	Safety, diagnostic accuracy	Approved globally	Developments in alternative imaging modalities
Gadavist (generic versions)	Multiple	-	Price competition	Approved post-patent expiration	Price erosion from generics
New Macrocyclic Agents (e.g., Gadobutrol)	Multiple	Growing	Safer, more stable gadolinium binding	Approved in multiple markets	Increased safety regulations favoring these agents
Non-Gadolinium Agents	Emerging biotech startups	Limited	No gadolinium required, novel contrast mechanisms	Under clinical trials	Technological breakthroughs in MRI contrast

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5. Regulatory Landscape Impact

• Global Regulatory Agencies: FDA (US), EMA (Europe), PMDA (Japan), NMPA (China).
• Critical Policies:
  • Gadolinium Retention: Restrictions on linear agents.
  • Indication Expansion: Regulatory pathways for off-label and new indications.
  • Safety Messaging: Emphasis on patient safety influencing prescribing patterns.

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6. Future Outlook & Growth Opportunities

Opportunity Area	Expected Impact	Challenges
Pipeline approvals	New revenue streams, extended patent protections	Regulatory hurdles, clinical trial costs
Geographic expansion	Increasing MRI usage in emerging markets	Market access, reimbursement policies
Innovation in safety profiles	Differentiation, market share gains	R&D investments, safety profile validation
Digital health integration	Enhanced diagnostics, personalized imaging	Adoption barriers, technology integration

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7. Key Takeaways

• Stable Market Position: GADAVIST remains a significant player in MRI contrast agents with an estimated global revenue of over $700 million in 2023.
• Growth Drivers: Rising MRI procedures, technological innovations, and expanding indications support moderate revenue growth.
• Competitive Dynamics: Market share is gradually eroding due to generics and alternative agents, but safety advantages confer a competitive edge.
• Regulatory & Safety Factors: Gadolinium retention concerns favor macrocyclic agents like Gadavist, while restrictions on linear agents enhance GADAVIST's marketability.
• Financial Trajectory: Projected to grow at approximately 2.6–4.2% annually through 2027, driven by increased procedure volumes and pipeline approvals.
• Risks: Market saturation, regulatory shifts, patent expirations, and technological disruptions pose challenges.

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FAQs

Q1: What factors influence GADAVIST's market share stability?
A1: Key factors include safety profile, regulatory approvals, competition from generics and newer agents, and technological advancements in MRI imaging.

Q2: How do safety concerns surrounding gadolinium affect GADAVIST's usage?
A2: Safety concerns, especially gadolinium retention and NSF risks, favor macrocyclic agents like GADAVIST. Regulatory restrictions on linear agents reinforce its market position.

Q3: What are the key growth opportunities for GADAVIST?
A3: Expanding indications, entering emerging markets, pipeline developments, and safety profile enhancements present opportunities.

Q4: How does patent expiration impact GADAVIST's revenue?
A4: Patent expiry has led to increased generic competition, putting downward pressure on prices and margins while maintaining demand due to brand recognition and safety profile.

Q5: What is the outlook for newer contrast agents in the MRI market?
A5: Emerging agents that address safety concerns and offer diagnostic advantages may displace existing contrast media, but regulatory pathways and clinical validation are hurdles.

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References

[1] Frost & Sullivan, "Global MRI Contrast Agents Market," 2022.
[2] Bayer AG Annual Reports, 2021–2023.
[3] MarketWatch, "MRI Contrast Agents Market Share Analysis," 2023.
[4] EMA & FDA guidelines on gadolinium-based contrast agents, 2022.
[5] Global Neuroimaging Imaging Market, 2023.