GADOTERATE MEGLUMINE Drug Patent Profile

When do Gadoterate Meglumine patents expire, and what generic alternatives are available?

Gadoterate Meglumine is a drug marketed by Hainan Poly and Hengrui Pharma and is included in two NDAs.

The generic ingredient in GADOTERATE MEGLUMINE is gadoterate meglumine. Four suppliers are listed for this compound. Additional details are available on the gadoterate meglumine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gadoterate Meglumine

A generic version of GADOTERATE MEGLUMINE was approved as gadoterate meglumine by HAINAN POLY on June 17^th, 2024.

Summary for GADOTERATE MEGLUMINE

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	17
Patent Applications:	440
DailyMed Link:	GADOTERATE MEGLUMINE at DailyMed

Recent Clinical Trials for GADOTERATE MEGLUMINE

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

Sponsor	Phase
Guerbet	PHASE3
Bracco Imaging S.p.A.	PHASE3
Peter Caravan	PHASE2

See all GADOTERATE MEGLUMINE clinical trials

Pharmacology for GADOTERATE MEGLUMINE

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

US Patents and Regulatory Information for GADOTERATE MEGLUMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hainan Poly	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073-001	Jun 17, 2024	AP	RX	No	No
Hengrui Pharma	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	215304-002	Apr 11, 2022		DISCN	No	No
Hainan Poly	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073-004	Jun 17, 2024	AP	RX	No	No
Hengrui Pharma	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	215304-003	Apr 11, 2022		DISCN	No	No

Market Dynamics and Financial Trajectory for GADOTERATE MEGLUMINE

Last updated: February 19, 2026

What is GADOTERATE MEGLUMINE?

Gadoterate meglumine is an approved gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI). It enhances visualization of blood vessels and tissues to improve diagnostic accuracy.

Market Size and Growth Drivers

Global MRI Contrast Agent Market

• Valued at approximately $2.4 billion in 2022 (Fortune Business Insights).
• Projected to grow at a compound annual growth rate (CAGR) of 4.5%, reaching around $3.4 billion by 2030 (MarketsandMarkets).

Gadolinium-Based Contrast Agents Segment

• Represents about 70% of the overall MRI contrast market.
• Estimated to reach $2.4 billion in 2025 from $1.8 billion in 2022, a CAGR of 9% (IQVIA).

GADOTERATE MEGLUMINE Specifics

• Market share estimated at 10-15% of GBCA segment, influenced by safety perceptions.
• Predominant in hospitals in developed markets, with growth potential in emerging markets.

Competitive Landscape

Major Players

• GE Healthcare
• Bayer AG
• Bayer's Coldcare division produces gadoterate meglumine (trade name: Dotarem).
• Bracco Imaging
• Guerbet

Position of GADOTERATE MEGLUMINE

• Approved for various MRI procedures, including neurological imaging.
• Marked by a strong safety profile with a low incidence of adverse reactions.
• Generates revenues mainly in North America and Europe, with expansion in Asia.

Patent and Regulatory Status

• Patents expired or nearing expiration, increasing generic competition.
• FDA approval in 2013 for Dotarem.
• EMA approval in 2007, with ongoing reviews to expand indications.

Pricing and Revenue Trends

Year	Approximate Revenue (USD million)	Notes
2020	150	Pacific markets, minimal competition
2022	170	Slight growth, market stabilization
2025 (projected)	220	Increased demand, market expansion

Pricing pressure from generics is expected to drive margins down over time. Higher safety and efficacy profile may support premium pricing in niche applications.

Regulatory and Safety Considerations

• Gadolinium retention concerns have led to stricter regulations and market shifts.
• Post-2018, US FDA restricted macrocyclic GBCAs, including GADOTERATE MEGLUMINE, due to lower retention risks.
• Market dynamics favor agents with safer profiles, influencing sales trajectories.

Financial Trajectory: Revenue and Investment Outlook

• Steady revenue growth driven by increasing MRI procedures and expanding indications.
• R&D investments focus on refining safety profiles and exploring new imaging applications.
• Companies investing in marketing and regional expansion anticipate capturing additional market share, despite competition.

Market Risks and Opportunities

Risks

• Volatility from regulatory changes and litigation related to gadolinium retention.
• Competition from alternative imaging agents, including non-contrast MRI methods.
• Pricing pressures from generics due to patent expirations.

Opportunities

• Growing MRI utilization in oncology, neurology, and cardiology.
• Development of next-generation GBCA with improved safety.
• Expansion in emerging markets with increasing healthcare infrastructure.

Key Milestones

• FDA and EMA approval renewals.
• Launch of new formulations or indications.
• Strategic partnerships for market expansion.

Conclusions

Gadoterate meglumine remains a significant player within the MRI contrast agent space. While revenue growth has slowed due to market maturation and safety concerns, ongoing expansion into emerging markets and new indications sustains its financial trajectory. Patent expirations and generic competition pose challenges, but a strong safety profile and expanding MRI procedures support its continued relevance.

Key Takeaways

• The MRI contrast agent market is projected to grow at a CAGR of 4.5%, with gadolinium-based agents dominating.
• GADOTERATE MEGLUMINE holds a notable market share, primarily driven by safety advantages.
• Regulatory scrutiny continues to shape market dynamics, favoring agents with lower gadolinium retention risks.
• Revenue is expected to reach approximately $220 million globally by 2025, with growth moderating.
• Opportunities exist in adoption for new indications and emerging markets, despite rising competition and pricing pressures.

FAQs

1. What factors influence the pricing of gadoterate meglumine?
   Pricing is impacted by patent status, competition from generics, safety profile, and regional regulations.

2. How has gadolinium safety concerns affected GADOTERATE MEGLUMINE sales?
   Safety concerns have led to market restrictions and increased preference for macrocyclic GBCAs, positively affecting agents with better safety profiles like gadoterate meglumine.

3. What is the outlook for generic competition in this segment?
   Patent expirations increase generic competition, likely leading to price declines and margin compression.

4. Are there new formulations of gadoterate meglumine in development?
   No publicly disclosed new formulations are currently under development, but ongoing safety improvements are possible.

5. Which regions offer the highest growth potential?
   Emerging markets in Asia-Pacific and Latin America have the highest growth potential due to expanding healthcare infrastructure.

References

[1] Fortune Business Insights. (2022). MRI Contrast Agent Market Size, Share & Industry Analysis.
[2] MarketsandMarkets. (2021). MRI Contrast Agents Market Forecast to 2030.
[3] IQVIA. (2022). Global Imaging Agents Market Report.