Gadobutrol - Generic Drug Details

What are the generic sources for gadobutrol and what is the scope of patent protection?

Gadobutrol is the generic ingredient in two branded drugs marketed by Bayer Hlthcare, Hainan Poly Pharm, and Hengrui Pharma, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for gadobutrol. Three suppliers are listed for this compound.

Summary for gadobutrol

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	42
Patent Applications:	1,310
What excipients (inactive ingredients) are in gadobutrol?	gadobutrol excipients list
DailyMed Link:	gadobutrol at DailyMed

Recent Clinical Trials for gadobutrol

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

Sponsor	Phase
National Institutes of Health (NIH)	Early Phase 1
Lipella Pharmaceuticals, Inc.	Early Phase 1
Christopher J Chermansky, MD	Early Phase 1

See all gadobutrol clinical trials

Pharmacology for gadobutrol

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

Anatomical Therapeutic Chemical (ATC) Classes for gadobutrol

V08CA	Paramagnetic contrast media
V08C	MAGNETIC RESONANCE IMAGING CONTRAST MEDIA
V08	CONTRAST MEDIA
V	Various

US Patents and Regulatory Information for gadobutrol

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	201277-005	Mar 14, 2011	AP	RX	Yes	Yes
Hainan Poly Pharm	GADOBUTROL	gadobutrol	SOLUTION;INTRAVENOUS	217480-003	Apr 16, 2025	AP	RX	No	No
Hengrui Pharma	GADOBUTROL	gadobutrol	SOLUTION;INTRAVENOUS	216081-002	Sep 8, 2023	AP	RX	No	No
Hengrui Pharma	GADOBUTROL	gadobutrol	SOLUTION;INTRAVENOUS	216081-001	Sep 8, 2023	AP	RX	No	No
Hainan Poly Pharm	GADOBUTROL	gadobutrol	SOLUTION;INTRAVENOUS	217480-006	Apr 16, 2025	AP	RX	No	No
Hengrui Pharma	GADOBUTROL	gadobutrol	SOLUTION;INTRAVENOUS	216081-006	Nov 17, 2022	AP	RX	No	No

Expired US Patents for gadobutrol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-003	Mar 14, 2011	5,980,864
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-005	Mar 14, 2011	5,980,864
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-006	Dec 18, 2013	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
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-001	Mar 14, 2011	5,980,864

Market Dynamics and Financial Trajectory of Gadobutrol

Introduction to Gadobutrol

Gadobutrol, marketed under the trade name Gadavist, is a macrocyclic gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI). It has been widely used since its introduction in 1998 and has established a strong presence in the medical imaging market.

Market Growth and Projections

The Gadobutrol market is poised for significant growth over the forecast period from 2024 to 2031. Here are some key points indicating this growth:

• CAGR and Revenue: The market is expected to grow at a remarkable Compound Annual Growth Rate (CAGR) during the forecast period, leading to substantial revenue growth[1].
• Historical Performance: Over the past few years, the Gadobutrol market has experienced rapid and considerable growth, setting a strong foundation for continued expansion[1].

Market Segmentation

The market is segmented based on several factors, which help in understanding its dynamics better:

• Type: The market is categorized into Single Dose Vials (2 mL, 7.5 mL, 10 mL, and 15 mL) and Pharmacy Bulk Packages (30 mL and 65 mL)[1].
• Application: Gadobutrol is used in both adult and pediatric populations[1].
• Geography: The market spans across North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1].

Drivers of Market Growth

Several factors are driving the growth of the Gadobutrol market:

• Increasing Demand for MRI Procedures: The rising need for diagnostic imaging due to an increase in chronic diseases and the aging population is a significant driver. MRI procedures, which often require contrast agents like Gadobutrol, are becoming more common[1].
• Safety Profile: Gadobutrol has a well-established safety profile, with over 100 million administrations worldwide showing a low incidence of adverse events. This safety record enhances its market appeal[4].
• Regulatory Approvals and Agreements: Recent licensing and supply agreements, such as the one between Zydus Lifesciences and Viwit Pharmaceuticals, are expanding the market reach of Gadobutrol in regions like the US[2].

Market Opportunities

The Gadobutrol market presents several opportunities for growth and expansion:

• Emerging Markets: Regions like Asia-Pacific and South America offer significant growth potential due to increasing healthcare spending and improving diagnostic infrastructure[1].
• Generic Versions: The introduction of generic versions of Gadobutrol, such as the one by Zydus and Viwit, can increase market penetration by offering cost-effective alternatives[2].

Challenges and Restraints

Despite the positive outlook, there are challenges that the Gadobutrol market faces:

• Safety Concerns: Although rare, adverse reactions such as hypersensitivity and nephrogenic systemic fibrosis (NSF) are associated with gadolinium-based contrast agents. These risks need to be managed through appropriate labeling and patient monitoring[4][5].
• Competition: The market for MRI contrast agents is competitive, with other macrocyclic and linear GBCAs available. New entrants, like gadopiclenol, may also impact market dynamics[3].

Competitive Landscape

The competitive landscape of the Gadobutrol market is characterized by:

• Key Players: Companies like Bayer HealthCare Pharmaceuticals, Zydus Lifesciences, and other generic manufacturers play a significant role in the market. These companies are involved in various activities such as licensing agreements, new product introductions, and mergers and acquisitions[1][2].
• Market Share: The top five companies in the market have a substantial market share, with Bayer HealthCare Pharmaceuticals being a major player due to its long-standing presence and brand recognition[1].

Financial Trajectory

The financial outlook for the Gadobutrol market is promising:

• Revenue Projections: The market is expected to generate significant revenue, with the total addressable market opportunity for gadobutrol injection estimated at US$ 120 million in the US market alone[2].
• Market Size: The global market size is projected to grow substantially, driven by increasing demand and expanding market reach[1].

Regional Market Analysis

The market performance varies across different regions:

• North America and Europe: These regions are expected to continue their strong performance due to advanced healthcare infrastructure and high demand for diagnostic imaging[1].
• Asia-Pacific: This region is anticipated to show rapid growth due to increasing healthcare spending and improving diagnostic capabilities[1].

Emerging Trends

Several trends are shaping the future of the Gadobutrol market:

• Generic and Biosimilar Products: The introduction of generic and biosimilar versions of Gadobutrol is expected to increase market competition and affordability[2].
• Advancements in MRI Technology: Improvements in MRI technology are likely to enhance the demand for high-quality contrast agents like Gadobutrol[1].

Regulatory Environment

The regulatory environment plays a crucial role in the Gadobutrol market:

• FDA Approvals: Gadobutrol has received regulatory approvals, and any new developments or updates in regulatory requirements can impact the market[5].
• Postmarketing Surveillance: Continuous monitoring of safety data through postmarketing surveillance helps in maintaining the drug's safety profile and regulatory compliance[4].

Conclusion

The Gadobutrol market is poised for significant growth driven by its well-established safety profile, increasing demand for MRI procedures, and expanding market reach through licensing agreements and generic versions. While challenges such as safety concerns and competition exist, the overall financial trajectory of the market is promising.

Key Takeaways

• Strong Market Growth: The Gadobutrol market is expected to grow at a remarkable CAGR from 2024 to 2031.
• Safety Profile: Gadobutrol has a well-established safety profile with over 100 million administrations worldwide.
• Market Segmentation: The market is segmented by type, application, and geography.
• Regulatory Approvals: Recent licensing agreements and FDA approvals are expanding the market reach.
• Financial Projections: The market is projected to generate significant revenue, with a total addressable market opportunity of US$ 120 million in the US.

FAQs

Q: What is Gadobutrol used for? A: Gadobutrol is a macrocyclic gadolinium-based contrast agent used in magnetic resonance imaging (MRI) to enhance the visibility of internal body structures.

Q: Who are the key players in the Gadobutrol market? A: Key players include Bayer HealthCare Pharmaceuticals, Zydus Lifesciences, and other generic manufacturers.

Q: What are the main drivers of the Gadobutrol market growth? A: The main drivers include increasing demand for MRI procedures, a well-established safety profile, and expanding market reach through licensing agreements.

Q: What are the potential challenges for the Gadobutrol market? A: Challenges include safety concerns such as hypersensitivity and nephrogenic systemic fibrosis, as well as competition from other MRI contrast agents.

Q: What is the estimated market size for Gadobutrol in the US? A: The total addressable market opportunity for gadobutrol injection is estimated at US$ 120 million in the US market.

Sources

1. Global Gadobutrol Market Size, Trends and Projections - Market Research Intellect
2. Zydus announces exclusive licensing and supply agreement for two Gadolinium based Magnetic Resonance Imaging (MRI) injectable, contrast agents - Biospace
3. 216986Orig1s000 - accessdata.fda.gov - FDA
4. Clinical Safety of Gadobutrol: Review of Over 25 Years of Use - PubMed
5. 201277 Gadobutrol Clinical PREA - FDA - FDA

Last updated: 2024-12-16