Flutemetamol f-18 - Generic Drug Details

What are the generic sources for flutemetamol f-18 and what is the scope of freedom to operate?

Flutemetamol f-18 is the generic ingredient in one branded drug marketed by Ge Healthcare and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Flutemetamol f-18 has eighty-four patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for flutemetamol f-18

International Patents:	84
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	19
Patent Applications:	279
What excipients (inactive ingredients) are in flutemetamol f-18?	flutemetamol f-18 excipients list
DailyMed Link:	flutemetamol f-18 at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for flutemetamol f-18

Constraining patent/regulatory exclusivity:

8,916,131

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 flutemetamol f-18

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

Sponsor	Phase
Yale University	Phase 1
Shanghai Mental Health Center	Phase 4
Maastricht University Medical Center	Phase 2/Phase 3

See all flutemetamol f-18 clinical trials

Pharmacology for flutemetamol f-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

US Patents and Regulatory Information for flutemetamol f-18

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	203137-002	Oct 25, 2013		RX	Yes	Yes	8,236,282		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	203137-001	Oct 25, 2013		DISCN	Yes	No	7,270,800		Y	Y

Expired US Patents for flutemetamol f-18

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

International Patents for flutemetamol f-18

Country	Patent Number	Title	Estimated Expiration
Australia	2008202626	Thioflavin derivatives and their use in diagnosis and therapy of Alzheimer's disease
European Patent Office	2182988	COMPOSITION RADIOPHARMACEUTIQUE (RADIOPHARMACEUTICAL COMPOSITION)
Brazil	PI0113470	composto de ligação amilóide, composição farmacêutica e métodos de síntese de composto, de detecção in vivo de depósitos amilóides num indivíduo e em tecido humano ou animal, de quantificação de depósito amilóide em tecido de biópsia ou postmortem e de distinção de um cérebro de doença de alzheimer de um cérebro normal
South Korea	101571572

Supplementary Protection Certificates for flutemetamol f-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2182988	C300723	Netherlands		PRODUCT NAME: FLUTEMETAMOL (18 F); REGISTRATION NO/DATE: EU/1/14/941 20140822
1611115	2015/004	Ireland		PRODUCT NAME: VIZAMYL-FLUTEMETAMOL (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
1334091	PA2015001,C1334091	Lithuania		PRODUCT NAME: FLUTEMETAMOLIS (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
2182988	2015006	Norway		PRODUCT NAME: VIZAMYL; REG. NO/DATE: EU/1/14/941 20140822

Flutemetamol f-18 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Flutemetamol F-18

Introduction to Flutemetamol F-18

Flutemetamol F-18, marketed under the brand name Vizamyl, is a diagnostic radiopharmaceutical used in Positron Emission Tomography (PET) imaging to estimate β-amyloid neuritic plaque density in the brains of adult patients. This is particularly useful in the evaluation of Alzheimer's disease and other causes of cognitive decline[2][4][5].

Market Driving Factors

Advancements in Imaging Technology

The market for Flutemetamol F-18 is significantly driven by advancements in imaging technology, particularly in PET scanning. Improved imaging techniques and the development of more sensitive and specific radiotracers have enhanced the diagnostic accuracy and utility of PET scans in neurology[1].

Growth in PET Imaging

The increasing use of PET imaging in clinical practice, especially for neurodegenerative diseases, has boosted the demand for diagnostic agents like Flutemetamol F-18. This growth is fueled by the rising incidence of Alzheimer's disease and the need for early and accurate diagnosis[1].

Regulatory Approval and Compliance

First Approval Date

Flutemetamol F-18 was first approved by the US FDA on October 25, 2013. This approval marked a significant milestone in the market trajectory of the drug, opening up new diagnostic avenues for clinicians[1][5].

Regulatory Requirements

The FDA has established specific guidelines and training programs for the use of Flutemetamol F-18 to ensure accurate image interpretation and minimize risks. This includes the completion of an electronic self-training program by healthcare professionals[5].

Pharmacoeconomics and Pricing

Manufacturing and Distribution

The drug is manufactured by GE Healthcare, and its distribution is managed through various channels to ensure availability in healthcare settings. The pricing of Flutemetamol F-18 is not publicly disclosed, but it is generally covered under diagnostic imaging services in healthcare plans[2][4].

Patents and Exclusivity

Flutemetamol F-18 has several patents that protect its exclusivity, with some patents expiring between 2023 and 2028. These patents play a crucial role in the financial trajectory by preventing generic competition during the patent period[2].

Clinical Efficacy and Safety

Diagnostic Performance

Clinical studies have established the diagnostic performance of Flutemetamol F-18 in detecting β-amyloid plaques. The drug has shown a strong correlation between PET imaging results and histopathological findings, making it a reliable diagnostic tool[4][5].

Safety Profile

While Flutemetamol F-18 is generally safe, it can cause hypersensitivity reactions and increases the patient's cumulative exposure to radiation. These risks are managed through careful patient selection and adherence to safety protocols[4][5].

Market Competition

Competitive Landscape

The market for amyloid PET imaging agents includes other competitors like Florbetapir F-18. However, Flutemetamol F-18 has carved out a niche due to its specific binding characteristics and clinical validation[5].

Financial Trajectory

Revenue Growth

The revenue from Flutemetamol F-18 has seen steady growth since its approval, driven by increasing adoption in clinical practice and the expanding need for accurate Alzheimer's disease diagnosis. The exact financial figures are not publicly disclosed, but the drug is considered a significant contributor to the diagnostic radiopharmaceutical market[1].

Cost-Benefit Analysis

The cost-benefit analysis of Flutemetamol F-18 is favorable due to its ability to provide early and accurate diagnosis, which can lead to better patient outcomes and reduced long-term healthcare costs. However, the high cost of PET imaging and the need for specialized equipment and training can be barriers to widespread adoption[4].

Future Outlook

Expanding Indications

There is potential for expanding the indications of Flutemetamol F-18 to other neurodegenerative diseases beyond Alzheimer's, which could further boost its market presence and financial performance[2].

Technological Advancements

Continued advancements in PET imaging technology and the development of new radiotracers could enhance the diagnostic capabilities of Flutemetamol F-18, maintaining its competitive edge in the market[1].

Key Takeaways

• Market Drivers: Advancements in imaging technology and growth in PET imaging drive the market for Flutemetamol F-18.
• Regulatory Compliance: FDA approval and specific training programs are crucial for the safe and effective use of the drug.
• Pharmacoeconomics: The drug is protected by patents, and its pricing is part of diagnostic imaging services.
• Clinical Efficacy: Strong diagnostic performance and a manageable safety profile contribute to its market success.
• Market Competition: Flutemetamol F-18 competes with other amyloid PET imaging agents but maintains a strong market position.
• Financial Trajectory: Steady revenue growth driven by increasing adoption and potential for expanding indications.

Frequently Asked Questions (FAQs)

Q1: What is Flutemetamol F-18 used for? Flutemetamol F-18 is used in Positron Emission Tomography (PET) imaging to estimate β-amyloid neuritic plaque density in the brains of adult patients, particularly for diagnosing Alzheimer's disease and other causes of cognitive decline.

Q2: When was Flutemetamol F-18 approved by the FDA? Flutemetamol F-18 was approved by the FDA on October 25, 2013.

Q3: What are the potential side effects of Flutemetamol F-18? The drug can cause hypersensitivity reactions and increases the patient's cumulative exposure to radiation. Other potential side effects include eye/face swelling, pallor, dyspnea, and skin tightness.

Q4: How does Flutemetamol F-18 work? Flutemetamol F-18 accumulates in β-amyloid plaques in the brain, making them visible via PET imaging. The drug binds to these plaques, allowing for the detection of neuritic and diffuse amyloid β deposits.

Q5: What is the financial outlook for Flutemetamol F-18? The financial outlook is positive, with steady revenue growth driven by increasing adoption in clinical practice and potential for expanding indications to other neurodegenerative diseases.

Cited Sources:

1. Synapse: Flutemetamol F-18 - Drug Targets, Indications, Patents[1]
2. DrugBank: Flutemetamol (18F): Uses, Interactions, Mechanism of Action[2]
3. Wiley Online Library: Appropriate use criteria for amyloid PET: A report of the Amyloid Imaging Task Force[3]
4. European Medicines Agency: Vizamyl, INN-flutemetamol (18F) - Product Information[4]
5. FDA: 203137Orig1s000 - Vizamyl (Flutemetamol F 18)[5]