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VIZAMYL Drug Patent Profile

Which patents cover Vizamyl, and when can generic versions of Vizamyl launch?

Vizamyl is a drug marketed by Ge Healthcare and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-four patent family members in twenty-five countries.

The generic ingredient in VIZAMYL is flutemetamol f-18. One supplier is listed for this compound. Additional details are available on the flutemetamol f-18 profile page.

DrugPatentWatch^® Generic Entry Outlook for Vizamyl

Vizamyl was eligible for patent challenges on October 25, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 16, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VIZAMYL

International Patents:	84
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	6
Patent Applications:	99
Drug Prices:	Drug price information for VIZAMYL
What excipients (inactive ingredients) are in VIZAMYL?	VIZAMYL excipients list
DailyMed Link:	VIZAMYL at DailyMed

See drug prices for VIZAMYL

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VIZAMYL

Constraining patent/regulatory exclusivity:

8,916,131

NDA:

203137

Dosage:

INJECTABLE;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VIZAMYL

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

Sponsor	Phase
Yale University	Phase 1
University of Utah	Phase 2
University Hospital, Toulouse	Early Phase 1

See all VIZAMYL clinical trials

Pharmacology for VIZAMYL

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

US Patents and Regulatory Information for VIZAMYL

VIZAMYL is protected by three US patents.

This potential generic entry date is based on patent 8,916,131.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013		DISCN	Yes	No	7,270,800		Y	Y
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013		RX	Yes	Yes	7,270,800		Y	Y
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013		DISCN	Yes	No	8,236,282		Y	Y
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013		DISCN	Yes	No	8,916,131		Y
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013		RX	Yes	Yes	8,236,282		Y	Y
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013		RX	Yes	Yes	8,916,131		Y

Expired US Patents for VIZAMYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013	7,351,401
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013	7,351,401
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013	8,236,282
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013	8,691,185
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013	8,236,282
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013	8,691,185

International Patents for VIZAMYL

When does loss-of-exclusivity occur for VIZAMYL?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Russian Federation

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VIZAMYL around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1146710	RADIOPHARMACEUTICAL COMPOSITION
Portugal	2182988
Russian Federation	2005131872	ПРОИЗВОДНЫЕ БЕНЗОТИАЗОЛА (ВАРИАНТЫ), ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ДЕТЕКЦИИ ОТЛОЖЕНИЙ АМИЛОИДА И СПОСОБ ИХ ДЕТЕКЦИИ У МЛЕКОПИТАЮЩЕГО
Poland	1611115
Portugal	1611115
Brazil	PI0408274	compostos de ligação de amilóide, composição farmacêutica e método de detecção de depósito de amilóide in vivo

Supplementary Protection Certificates for VIZAMYL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2182988	6/2015	Austria		PRODUCT NAME: (18F) - FLUTEMETAMOL; REGISTRATION NO/DATE: EU/1/14/941 (MITTEILUNG) 20140826
2182988	2015006	Norway		PRODUCT NAME: VIZAMYL; REG. NO/DATE: EU/1/14/941 20140822
1611115	C20150004 00139	Estonia		PRODUCT NAME: FLUTEMETAMOOL (18F);REG NO/DATE: EU/1/14/941 26.08.2014
2182988	CR 2015 00008	Denmark		PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140826
1611115	2015/004	Ireland		PRODUCT NAME: VIZAMYL-FLUTEMETAMOL (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
2182988	SPC/GB15/012	United Kingdom		PRODUCT NAME: FLUTEMETAMOL (18F) OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTERED: UK EU/1/14/941 20140826

VIZAMYL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vizamyl

Introduction

Vizamyl, a radioactive diagnostic agent developed by GE Healthcare, is a crucial tool in the diagnosis of Alzheimer's disease. Here, we delve into the market dynamics and financial trajectory of Vizamyl, highlighting its growth potential, market challenges, and the broader impact on GE Healthcare's financial performance.

Market Context and Growth Opportunities

Theranostics Market Expansion

The theranostics market, which includes equipment, tracers, and therapies, is poised for significant growth. Currently valued at around $9 billion, it is expected to reach $40 billion by 2032. Vizamyl, as a key player in this market, is well-positioned to benefit from this expansion, particularly as novel therapies for Alzheimer's and other diseases become more widely available[1].

Increasing Demand for Diagnostic Tools

The growing need for precise diagnostic tools, especially in the context of Alzheimer's disease, drives the demand for Vizamyl. As the only amyloid imaging agent with FDA approval for color image interpretation, Vizamyl enhances diagnostic certainty, increasing physician confidence in their diagnoses from 69% to 88% in 87% of patients[4].

Financial Performance and Trends

Revenue Growth

In the second quarter of 2024, GE Healthcare reported a significant increase in Vizamyl doses delivered in the U.S., with sales tripling compared to the previous year. This strong performance is a testament to the growing adoption of Vizamyl in clinical practice[2].

Segment Contribution

The Pharmaceutical Diagnostics segment, which includes Vizamyl, has been a strong performer for GE Healthcare. In the first quarter of 2024, this segment saw an 8% year-over-year organic growth, driven by price and volume increases. The segment's EBIT margin improved by 190 basis points year-over-year, reflecting the positive impact of Vizamyl and other imaging agents[3].

Market Challenges and Headwinds

Global Market Variations

While Vizamyl has seen robust growth in the U.S., GE Healthcare faces challenges in other markets, particularly in China. Market headwinds in China have negatively impacted overall sales growth, with a high teens decline in China sales anticipated for the second half of 2024. However, the company remains optimistic about long-term growth potential in these regions[2].

Supply Chain and Pricing Factors

The recovery of supply chains and pricing advantages have contributed to GE Healthcare's revenue growth in the past year. However, these factors can be volatile and may impact future performance. The company has attributed last year's gains to these factors but does not expect the same trajectory to continue into the next year[1].

Strategic Initiatives and Future Outlook

Integration of New Technologies

GE Healthcare is enhancing its theranostics franchise through organic and inorganic expansions. The proposed acquisition of MIM Software and the integration of its imaging analysis programs are expected to further strengthen the company's position in the market. These initiatives will particularly benefit Vizamyl by improving imaging analysis and radiation oncology capabilities[1].

Care Pathway and Precision Innovation Strategies

GE Healthcare is progressing with its care pathway strategy and Precision innovation strategy, which include the development and deployment of advanced imaging technologies. These strategies are expected to drive mid-single-digit growth in orders and revenue in the second half of 2024, further bolstering Vizamyl's market presence[3].

Regulatory and Pipeline Developments

FDA Approvals and Pipeline Products

The FDA approval for Flurpiridaz, another pipeline product for diagnosing and assessing coronary artery disease, is expected in the next few years. Although this approval is not anticipated to impact 2024 guidance, it will significantly advance PET/CT imaging and contribute to the broader growth of GE Healthcare's diagnostic portfolio, including Vizamyl[3].

Key Takeaways

• Market Growth: Vizamyl is positioned to benefit from the expanding theranostics market, expected to grow to $40 billion by 2032.
• Financial Performance: Strong revenue growth in the U.S. market, with Vizamyl doses delivered tripling in the second quarter of 2024.
• Segment Contribution: The Pharmaceutical Diagnostics segment, which includes Vizamyl, has seen significant organic growth and margin expansion.
• Challenges: Market headwinds in China and supply chain volatility could impact future performance.
• Strategic Initiatives: Integration of new technologies and strategic initiatives are expected to enhance Vizamyl's market position and drive future growth.

FAQs

What is Vizamyl used for?

Vizamyl is a radioactive diagnostic agent used for PET imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment suspected of Alzheimer's disease[4].

How has Vizamyl's sales performance been in recent quarters?

Vizamyl has seen significant sales growth, particularly in the U.S., with doses delivered tripling in the second quarter of 2024 compared to the previous year[2].

What are the market challenges facing Vizamyl?

Market headwinds in China and temporary supply chain disruptions are among the challenges impacting Vizamyl's sales growth[2].

How does Vizamyl contribute to GE Healthcare's financial performance?

Vizamyl is part of the Pharmaceutical Diagnostics segment, which has contributed to GE Healthcare's strong organic growth and margin expansion[3].

What are the future growth prospects for Vizamyl?

Vizamyl is expected to benefit from the growing theranostics market and GE Healthcare's strategic initiatives, including the integration of new technologies and the expansion of its care pathway and Precision innovation strategies[1][3].

Sources

1. FierceBiotech: "GE HealthCare plots theranostics growth as it beats earnings estimates in first independent year"[1].
2. Investing.com: "Earnings call: GE Healthcare maintains guidance amid market challenges"[2].
3. Investing.com: "Earnings call: GE Healthcare affirms 2024 outlook, sees growth potential"[3].
4. GE Healthcare: "Vizamyl™ (Flutemetamol F18 Injection)"[4].