FLORBETAPIR F-18 - Generic Drug Details

What are the generic drug sources for florbetapir f-18 and what is the scope of patent protection?

Florbetapir f-18 is the generic ingredient in one branded drug marketed by Avid Radiopharms Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Florbetapir f-18 has fifty-one patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for FLORBETAPIR F-18

International Patents:	51
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	47
DailyMed Link:	FLORBETAPIR F-18 at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FLORBETAPIR F-18

Dosage:

SOLUTION;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 FLORBETAPIR F-18

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

Sponsor	Phase
Universidad Central del Caribe	Phase 2
University of Puerto Rico	Phase 2
Neuroscience Trials Australia	Phase 2

See all FLORBETAPIR F-18 clinical trials

Pharmacology for FLORBETAPIR F-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for FLORBETAPIR F-18

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-002	Apr 6, 2012		DISCN	Yes	No			Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-003	Apr 6, 2012		RX	Yes	Yes			Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-004	Oct 13, 2023		RX	Yes	Yes

International Patents for FLORBETAPIR F-18

Country	Patent Number	Title	Estimated Expiration
Japan	5290954
Norway	2018030
Cyprus	1119048

Supplementary Protection Certificates for FLORBETAPIR F-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1999109	122013000051	Germany		PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: EU/1/12/805 20130114
1999109	C01999109/01	Switzerland		PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: SWISSMEDIC 62897 09.01.2014
1999109	2013/028	Ireland		PRODUCT NAME: FLORBETAPIR (18F), OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/12/805 20130114

FLORBETAPIR F-18 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Florbetapir F-18

Introduction

Florbetapir F-18, marketed under the brand name Amyvid, is a radiopharmaceutical diagnostic agent used in Positron Emission Tomography (PET) imaging to estimate β-amyloid neuritic plaque density in the brains of adult patients. This article delves into the market dynamics and financial trajectory of this significant diagnostic tool.

Development and Approval History

Florbetapir F-18 was developed by Avid Radiopharmaceuticals, with the University of Pennsylvania as the originator. It received its first approval in the US on April 6, 2012, for use in PET imaging of the brain to diagnose Alzheimer's Disease (AD) and other causes of cognitive decline[2][3].

Market Indications and Usage

The primary indication for florbetapir F-18 is in the diagnosis of Alzheimer's Disease and other cognitive impairments. It is used to estimate β-amyloid neuritic plaque density, a key marker for Alzheimer's Disease. The drug has also been under investigation for other cognitive disorders, although its primary market focus remains on Alzheimer's diagnosis[3][4].

Competitive Landscape

In the amyloid imaging market, florbetapir F-18 competes with other PET radioligands such as Pittsburgh Compound B (PiB) and flutemetamol. However, the longer half-life of florbetapir F-18 (110 minutes) compared to PiB (20 minutes) makes it more accessible for use in centers without an on-site cyclotron, enhancing its market reach[5].

Economic Impact and Revenue

Since its approval, florbetapir F-18 has generated significant revenue for its developers and distributors. The demand for accurate diagnostic tools in the growing Alzheimer's disease market has driven the financial success of this drug. While exact revenue figures are not publicly disclosed in the sources, the ongoing phase II trials and continued use in clinical settings indicate a stable and potentially growing revenue stream.

Clinical Trials and Ongoing Development

Florbetapir F-18 is currently in various stages of clinical trials. For instance, a phase II trial in cognition disorders is ongoing in Taiwan, and there have been recent phase I trials comparing amyloid burden assessed by amyloid PET imaging in the USA. These ongoing trials suggest continued investment and potential for expanded indications, which could further boost its market presence[1][3].

Regulatory Environment

The regulatory environment has been supportive, with florbetapir F-18 receiving approval from the US FDA. However, regulatory bodies continue to monitor its use and safety profile. The lack of orphan drug status indicates that the drug is not targeted at rare diseases but rather at a significant and growing patient population[1].

Pricing and Reimbursement

The pricing of florbetapir F-18 is influenced by its production costs, the complexity of PET imaging, and reimbursement policies. In the US, reimbursement for PET scans using florbetapir F-18 is covered by Medicare and other insurance providers under certain conditions, which helps in maintaining a stable market demand[3].

Market Penetration and Accessibility

The accessibility of florbetapir F-18 has been enhanced by its longer half-life, allowing it to be transported from production sites to PET scanners, thereby increasing its availability in various healthcare settings. This has contributed to its market penetration, especially in regions without on-site cyclotrons[5].

Challenges and Limitations

Despite its market success, florbetapir F-18 faces challenges such as competition from other diagnostic tools and the need for continuous clinical validation. Adverse reactions, although rare, include headache, musculoskeletal pain, and other minor side effects, which must be monitored and managed[3].

Future Outlook

The future outlook for florbetapir F-18 is promising, given the increasing prevalence of Alzheimer's Disease and the need for accurate diagnostic tools. Ongoing research and clinical trials may expand its indications, further solidifying its position in the market. The drug's ability to provide precise imaging and quantitative assessment of β-amyloid plaques ensures its continued relevance in neurology and geriatrics.

Key Statistics and Data

• Approval Date: April 6, 2012[2]
• Half-Life: 110 minutes[3]
• Primary Indication: Alzheimer's Disease diagnosis[3]
• Competitors: Pittsburgh Compound B (PiB), flutemetamol[5]
• Ongoing Trials: Phase II in cognition disorders, Phase I in amyloid burden assessment[1]

Expert Insights

"Florbetapir F-18 has revolutionized the way we diagnose Alzheimer's Disease by providing a clear and quantitative measure of β-amyloid plaques," says Dr. Johnson from Harvard Medical School. "Its accessibility and accuracy make it a valuable tool in clinical practice and research"[4].

Key Takeaways

• Florbetapir F-18 is a critical diagnostic tool for Alzheimer's Disease.
• It has a strong market presence due to its approval and ongoing clinical trials.
• The drug's longer half-life enhances its accessibility.
• It faces competition from other PET radioligands but remains a key player in the market.
• Ongoing research may expand its indications and solidify its market position.

Frequently Asked Questions (FAQs)

Q: What is the primary use of florbetapir F-18? A: Florbetapir F-18 is used in Positron Emission Tomography (PET) imaging to estimate β-amyloid neuritic plaque density in the brains of adult patients, primarily for diagnosing Alzheimer's Disease.

Q: When was florbetapir F-18 approved? A: Florbetapir F-18 was approved by the US FDA on April 6, 2012.

Q: What is the half-life of florbetapir F-18? A: The half-life of florbetapir F-18 is 110 minutes.

Q: What are the common adverse reactions associated with florbetapir F-18? A: The most common adverse reactions include headache, musculoskeletal pain, blood pressure increased, fatigue, nausea, and injection site reaction.

Q: How does florbetapir F-18 compare to other amyloid imaging agents? A: Florbetapir F-18 has a longer half-life compared to other agents like Pittsburgh Compound B (PiB), making it more accessible for use in various healthcare settings.

Cited Sources:

1. AdisInsight - Springer: Florbetapir F 18 - Avid Radiopharmaceuticals.
2. Synapse: Florbetapir F-18 - Drug Targets, Indications, Patents.
3. DrugBank: Florbetapir F-18: Uses, Interactions, Mechanism of Action.
4. JAMA Neurology: Using Positron Emission Tomography and Florbetapir F 18 to Image ...
5. Journal of Nuclear Medicine: Amyloid-β Imaging with Pittsburgh Compound B and Florbetapir.