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:	30
Clinical Trials:	28
Patent Applications:	410
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
Lipella Pharmaceuticals, Inc.	Early Phase 1
Christopher J Chermansky, MD	Early Phase 1
National Institutes of Health (NIH)	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	201277-004	Mar 14, 2011
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-006	Dec 18, 2013
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-005	Mar 14, 2011
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-003	Mar 14, 2011
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-002	Mar 14, 2011
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-001	Mar 14, 2011

International Patents for GADAVIST

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1002811
Finland	911330
Canada	2038493	1,4,7,10-TETRAAZACYCLODODECANE BUTYLTRIOLS (1,4,7,10-TETRAAZACYCLODODECANE BUTYLTRIOLS)
Israel	97592	Tetraazacyclododecane butyltriol derivatives processes for the production thereof and pharmaceutical compositions containing the same
Finland	109695
Hungary	T60478

Supplementary Protection Certificates for GADAVIST

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

GADAVIST Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GADAVIST

Overview of GADAVIST

GADAVIST, also known as gadobutrol, is a gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI) to enhance the visibility of internal body structures. It is particularly notable for its use in cardiac MRI and neurological imaging.

Market Size and Growth

The U.S. gadolinium-based contrast media market, which includes GADAVIST, was valued at USD 527.9 million in 2019 and is projected to grow at a compound annual growth rate (CAGR) of 4.7% from 2020 to 2027, reaching USD 766.37 million by 2027[1].

Key Market Drivers

Increasing Prevalence of Chronic Diseases

The growth of the market is significantly driven by the increasing prevalence of chronic diseases. According to the Centre for Disease Control and Prevention, six out of ten people in the U.S. suffer from chronic diseases, and four out of ten people suffer from comorbidities. These chronic conditions are major drivers of healthcare costs and the demand for diagnostic imaging agents like GADAVIST[1].

Technological Advancements

Technological advancements in MRI technology and the expansion of indications for GBCAs also contribute to market growth. For instance, the FDA approval of GADAVIST for cardiac MRI to assess myocardial perfusion and late gadolinium enhancement in adult patients with coronary artery disease has expanded its use[1].

Strategic Moves by Key Players

Companies like Bayer, the manufacturer of GADAVIST, are engaging in strategic moves such as mergers, acquisitions, and indication extensions to strengthen their market position. These strategies help in expanding the geographical reach and strengthening the product portfolio, which in turn drives market growth[1].

Segment Analysis

Neurology Segment

The neurology segment holds a significant share of the market, with GADAVIST being one of the most widely used macrocyclic GBCAs for neurological disorders. This segment accounted for almost 38.8% of the revenue share in 2019 due to the higher preference for GBCAs in neurological treatments[1].

Cardiovascular Segment

The approval of GADAVIST for cardiac MRI has also boosted its adoption in the cardiovascular segment. This indication allows for better visualization of myocardial perfusion and late gadolinium enhancement, making it a valuable tool in diagnosing coronary artery disease[1].

Financial Performance of Bayer

Bayer, the parent company of GADAVIST, has seen significant growth in its pharmaceutical division, which includes the radiology business. The sales of GADAVIST, along with other radiology products like Ultravist, have contributed to this growth. In 2022, the pharmaceutical division of Bayer saw a sales increase of 1.1% on a currency- and portfolio-adjusted basis, with strong growth recorded for radiology products[2].

Revenue and EBITDA

The revenue from GADAVIST and other radiology products has been substantial. For instance, the radiology business, which includes GADAVIST, saw a sales increase of 9.0% on a currency- and portfolio-adjusted basis in 2022. This growth contributed to the overall EBITDA of the pharmaceutical division, which rose by 1.6% to 5.873 billion euros[2].

Competitive Landscape

The market for gadolinium-based contrast media is highly competitive, with several domestic and international players. Companies are engaging in label expansions, mergers, and acquisitions to strengthen their product portfolios and expand geographically. The entry of generic versions, such as those announced by Zydus Lifesciences in partnership with Viwit Pharmaceuticals, is expected to increase competition in the market[3][4].

Generic Versions and Market Impact

Zydus Lifesciences has entered into an exclusive licensing and supply agreement with Viwit Pharmaceuticals for the generic versions of GADAVIST (gadobutrol injection) and DOTAREM (gadoterate meglumine injection). The total addressable market opportunity for these generic versions is estimated at USD 120 million for gadobutrol injection and USD 117 million for gadoterate meglumine injection in the U.S. market. This could potentially impact the market share of branded products like GADAVIST, although it may also expand the overall market by making these essential diagnostic tools more accessible[3][4].

Regulatory Approvals and Expansions

Regulatory approvals play a crucial role in the market dynamics of GADAVIST. For example, the FDA approval of GADAVIST for cardiac MRI has significantly expanded its use. Similar approvals and indication extensions by other players, such as GE Healthcare’s Clariscan, further enhance the competitive landscape and drive market growth[1].

Conclusion

The market for GADAVIST and other gadolinium-based contrast media is driven by increasing chronic disease prevalence, technological advancements, and strategic moves by key players. Bayer’s financial performance, particularly in the radiology segment, reflects the strong demand for these products. However, the entry of generic versions and the highly competitive nature of the market will continue to shape the financial trajectory and market dynamics of GADAVIST.

Key Takeaways

• Market Growth: The U.S. gadolinium-based contrast media market is expected to grow at a CAGR of 4.7% from 2020 to 2027.
• Chronic Diseases: Increasing prevalence of chronic diseases drives the demand for diagnostic imaging agents.
• Technological Advancements: Expansions in MRI technology and indications boost market growth.
• Competitive Landscape: The market is highly competitive with key players engaging in mergers, acquisitions, and indication extensions.
• Generic Versions: Entry of generic versions could impact market share but may also expand overall market accessibility.

FAQs

1. What is GADAVIST used for? GADAVIST (gadobutrol) is a gadolinium-based contrast agent used in MRI to enhance the visibility of internal body structures, particularly in cardiac and neurological imaging.

2. What is the projected market size for gadolinium-based contrast media by 2027? The U.S. gadolinium-based contrast media market is projected to reach USD 766.37 million by 2027[1].

3. Which segment holds the largest share in the market for GBCAs? The neurology segment holds the largest share, accounting for almost 38.8% of the revenue in 2019[1].

4. How does the entry of generic versions impact the market? The entry of generic versions can increase competition, potentially impacting the market share of branded products but also expanding overall market accessibility[3][4].

5. What are some key drivers of the market growth for GADAVIST? Key drivers include the increasing prevalence of chronic diseases, technological advancements, and strategic moves by key players such as mergers, acquisitions, and indication extensions[1].

Sources

1. Grand View Research: U.S. Gadolinium-based Contrast Media Market Report, 2027
2. Bayer: Significant growth in sales and earnings
3. PR Newswire: Zydus announces exclusive licensing and supply agreement for two gadolinium-based MRI injectable contrast agents in the US
4. BioSpace: Zydus announces exclusive licensing and supply agreement for two gadolinium-based MRI injectable contrast agents in the US