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TAUVID Drug Patent Profile

Which patents cover Tauvid, and what generic alternatives are available?

Tauvid is a drug marketed by Avid Radiopharms Inc and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-six patent family members in sixteen countries.

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

DrugPatentWatch^® Generic Entry Outlook for Tauvid

Tauvid was eligible for patent challenges on May 28, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 26, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TAUVID

International Patents:	26
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	9
Patent Applications:	9
What excipients (inactive ingredients) are in TAUVID?	TAUVID excipients list
DailyMed Link:	TAUVID at DailyMed

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

Constraining patent/regulatory exclusivity:

8,932,557

NDA:

212123

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 TAUVID

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

Sponsor	Phase
The Cleveland Clinic	Phase 1
Avid Radiopharmaceuticals	Phase 2
Avid Radiopharmaceuticals	Phase 1

See all TAUVID clinical trials

US Patents and Regulatory Information for TAUVID

TAUVID is protected by one US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 8,932,557.

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
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-001	May 28, 2020		DISCN	Yes	No	8,932,557			Y
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-002	May 28, 2020		DISCN	Yes	No
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-001	May 28, 2020		DISCN	Yes	No
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-002	May 28, 2020		DISCN	Yes	No	8,932,557			Y
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-004	Jul 1, 2022		RX	Yes	Yes	8,932,557			Y

International Patents for TAUVID

When does loss-of-exclusivity occur for TAUVID?

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

Australia

Canada

China

Colombia

Croatia

Denmark

European Patent Office

Hungary

Japan

Lithuania

Poland

Portugal

Slovenia

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 TAUVID around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20150002854	CARBOLINE AND CARBAZOLE BASED IMAGING AGENTS FOR DETECTING NEUROLOGICAL DYSFUNCTION
European Patent Office	2599763	Nouveaux agents d'imagerie pour la détection d'un dysfonctionnement neurologique (Novel imaging agents for detecting neurological dysfunction)
World Intellectual Property Organization (WIPO)	2009102498
China	104781234	Carboline and carbazole based imaging agents for detecting neurological dysfunction
South Korea	20100135235	NOVEL IMAGING AGENTS FOR DETECTING NEUROLOGICAL DYSFUNCTION

TAUVID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tauvid

Introduction

Tauvid, also known as flortaucipir F 18, is a groundbreaking diagnostic agent approved by the FDA for positron emission tomography (PET) imaging of the brain. It is specifically designed to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD). Here, we delve into the market dynamics and financial trajectory of Tauvid.

FDA Approval and Regulatory Framework

Tauvid was approved by the FDA on May 28, 2020, under the authority granted by Section 505(b)(1) of the Food, Drug, and Cosmetic Act. This approval marked a significant milestone as it is the first FDA-approved molecule for imaging aggregated tau protein in the brain[1][4].

Market Need and Demand

The demand for diagnostic tools in Alzheimer’s disease is increasing due to the growing prevalence of the condition and the need for accurate diagnosis. Tauvid fills a critical gap by providing a non-invasive method to visualize tau NFTs, which are a hallmark of Alzheimer’s pathology. This diagnostic capability is crucial for both clinical practice and research, driving a strong market demand[2].

Competitive Landscape

Currently, Tauvid is the only FDA-approved tau PET tracer, giving it a unique position in the market. While other diagnostic agents like amyloid-beta PET tracers exist, Tauvid’s specificity for tau NFTs makes it a valuable tool in the diagnostic arsenal for Alzheimer’s disease. This lack of direct competition enhances its market potential[2][4].

Clinical Validation and Adoption

Tauvid has been widely adopted and validated in numerous independent research and clinical settings. Studies have shown that the binding of flortaucipir to tau NFTs parallels NFT accumulation described by Braak stages, correlating with clinical symptoms and measures of neurodegeneration. This robust clinical validation has contributed to its rapid adoption in both research and clinical practice[2].

Financial Performance and Revenue Projections

The financial performance of Tauvid is closely tied to its adoption rate and the overall market demand for Alzheimer’s disease diagnostics. Given its unique approval status and the growing need for accurate Alzheimer’s diagnostics, Tauvid is expected to generate significant revenue. The approval and subsequent marketing by Avid Radiopharmaceuticals have positioned the drug for substantial financial growth.

Revenue Streams

• Clinical Use: The primary revenue stream for Tauvid comes from its use in clinical settings for diagnosing Alzheimer’s disease.
• Research: It is also used extensively in research studies, contributing to additional revenue.
• Licensing and Partnerships: Potential licensing agreements and partnerships with other pharmaceutical companies or research institutions could further boost revenue.

Market Size and Growth

The global market for Alzheimer’s disease diagnostics is expanding, driven by an increasing patient population and advancements in diagnostic technologies. With Tauvid being a pioneering product in this space, it is poised to capture a significant share of this growing market.

Challenges and Opportunities

Challenges

• Off-Target Binding: Tauvid exhibits off-target binding to monoamine oxidase MAO-A and MAO-B, as well as to regions containing high levels of melanin, neuromelanin, and iron. This could potentially affect its specificity and require careful interpretation of imaging results[4].
• Regulatory Environment: Changes in regulatory policies, such as those related to reimbursement and usage guidelines, could impact its market dynamics.

Opportunities

• Expanding Indications: There is potential for expanding the indications of Tauvid to other tauopathies beyond Alzheimer’s disease.
• Combination with Other Diagnostics: Integrating Tauvid with other diagnostic tools, such as amyloid-beta PET tracers, could enhance diagnostic accuracy and open up new market opportunities[2].

Impact on Healthcare and Research

Tauvid has revolutionized the field of Alzheimer’s disease diagnostics by providing a non-invasive method to visualize tau pathology. This has significant implications for both clinical management and research.

Clinical Management

• Accurate Diagnosis: Tauvid enables more accurate diagnosis of Alzheimer’s disease, allowing for better patient management and treatment planning.
• Monitoring Disease Progression: It can be used to monitor the progression of tau pathology, helping in the assessment of disease severity and response to treatment[1].

Research

• Understanding Alzheimer’s Pathology: Tauvid has facilitated deeper insights into the pathology of Alzheimer’s disease, particularly the role of tau NFTs.
• Drug Development: It is a valuable tool in clinical trials for Alzheimer’s disease treatments, helping to assess the efficacy of potential therapies[2].

Key Takeaways

• Unique Market Position: Tauvid is the first and only FDA-approved tau PET tracer, giving it a unique market position.
• Growing Demand: The demand for accurate Alzheimer’s disease diagnostics is increasing, driving the market for Tauvid.
• Clinical and Research Impact: Tauvid has significant implications for both clinical management and research in Alzheimer’s disease.
• Financial Growth: With its strong market position and growing demand, Tauvid is expected to generate substantial revenue.

FAQs

What is Tauvid used for?

Tauvid is used for PET imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease.

When was Tauvid approved by the FDA?

Tauvid was approved by the FDA on May 28, 2020.

What are the key benefits of using Tauvid?

The key benefits include accurate diagnosis of Alzheimer’s disease, monitoring of disease progression, and its role in research and clinical trials.

Does Tauvid have any off-target binding issues?

Yes, Tauvid exhibits off-target binding to monoamine oxidase MAO-A and MAO-B, as well as to regions containing high levels of melanin, neuromelanin, and iron.

How does Tauvid compare to other Alzheimer’s disease diagnostics?

Tauvid is the only FDA-approved tau PET tracer, making it unique in its ability to visualize tau NFTs, a hallmark of Alzheimer’s pathology.

Sources

1. FDA Integrated Review Template: "NDA 212123 Tauvid (flortaucipir F 18 injection)".
2. Academic.oup.com: "Review of the flortaucipir literature for positron emission tomography imaging of neurofibrillary tau tangles".
3. FDA Performance Report: "FY 2020 PDUFA Performance Report".
4. DrugBank: "Flortaucipir F-18: Uses, Interactions, Mechanism of Action".
5. CMS Comment Letter: "Eli Lilly Amyloid PET Reconsideration Comment Letter_July 2022".