Flortaucipir f-18 - Generic Drug Details

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

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

Flortaucipir f-18 has twenty-six patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for flortaucipir f-18

International Patents:	26
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	21
Patent Applications:	18
What excipients (inactive ingredients) are in flortaucipir f-18?	flortaucipir f-18 excipients list
DailyMed Link:	flortaucipir f-18 at DailyMed

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

Constraining patent/regulatory exclusivity:

8,932,557

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 flortaucipir f-18

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

Sponsor	Phase
Tharick Pascoal	Phase 1
Seelos Therapeutics, Inc.	Phase 2
National Institute on Aging (NIA)	Phase 1

See all flortaucipir f-18 clinical trials

US Patents and Regulatory Information for flortaucipir 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	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-003	Jul 1, 2022		RX	Yes	Yes	8,932,557			Y
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	212123-002	May 28, 2020		DISCN	Yes	No
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-004	Jul 1, 2022		RX	Yes	Yes	8,932,557			Y
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	212123-001	May 28, 2020		DISCN	Yes	No	8,932,557			Y

International Patents for flortaucipir f-18

Country	Patent Number	Title	Estimated Expiration
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
Denmark	2247558
Portugal	2247558
China	107011342	用于检测神经功能障碍的基于咔啉和咔唑的成像剂 (CARBOLINE AND CARBAZOLE BASED IMAGING AGENTS FOR DETECTING NEUROLOGICAL DYSFUNCTION)
World Intellectual Property Organization (WIPO)	2013176698
Spain	2792830

Flortaucipir f-18 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Flortaucipir F-18 (Tauvid™)

Introduction

Flortaucipir F-18, marketed under the name Tauvid™, is a groundbreaking radiopharmaceutical used in positron emission tomography (PET) imaging to assess the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients being evaluated for Alzheimer’s disease. Here, we delve into the market dynamics and financial trajectory of this innovative drug.

Regulatory Approval and Market Access

FDA Approval

Flortaucipir F-18 received FDA approval on May 28, 2020, marking a significant milestone as the first FDA-approved molecule for imaging aggregated tau protein in the brain[3].

European Market

Tauvid received a marketing authorization valid throughout the EU on August 22, 2024, expanding its reach to European markets[4].

Medicaid and Health Choice Coverage

In the United States, Medicaid and NC Health Choice programs began covering flortaucipir F-18 injections effective March 6, 2023, under the HCPCS code A9601. This coverage is crucial for increasing accessibility to the drug[2].

Market Demand and Growth

Clinical Need

The demand for flortaucipir F-18 is driven by the growing need for accurate diagnostic tools in Alzheimer’s disease. Alzheimer’s is a prevalent and debilitating condition, and the ability to visualize tau pathology in vivo has revolutionized diagnostic and prognostic capabilities[5].

Adoption in Clinical Settings

Flortaucipir F-18 has been widely adopted and validated in numerous independent research and clinical settings. Its high diagnostic and prognostic value in assessing neurofibrillary tau tangles has made it a preferred choice among clinicians[5].

Pricing and Reimbursement

Medicaid Reimbursement

For Medicaid and NC Health Choice beneficiaries, the maximum reimbursement rate per unit of flortaucipir F-18 is $378.52. Providers must bill the product with the HCPCS code A9601 and indicate the number of units[2].

General Pricing

The cost of flortaucipir F-18 can vary, but it is generally priced based on the dose and the specific healthcare program. The drug is typically administered in a dose of 370 MBq (10 mCi), and the billing is for the patient-ready dose vial only[2].

Financial Trajectory

Revenue Projections

Given its FDA approval and expanding market access, flortaucipir F-18 is expected to generate significant revenue. The demand for precise diagnostic tools in neurodegenerative diseases, coupled with its unique positioning as the first FDA-approved tau PET tracer, positions it for substantial market growth.

Cost-Benefit Analysis

The financial trajectory of flortaucipir F-18 is also influenced by its cost-benefit profile. While the drug is expensive, its ability to provide early and accurate diagnoses can lead to better patient outcomes and potentially reduce long-term healthcare costs associated with Alzheimer’s disease.

Competitive Landscape

Unique Selling Proposition

Flortaucipir F-18 holds a unique position in the market as the only FDA-approved tau PET tracer. Its ability to bind to aggregated tau protein and provide in vivo visualization of NFTs sets it apart from other diagnostic tools[3].

Future Competitors

While flortaucipir F-18 currently dominates the tau PET imaging market, ongoing research and development in the field of neurodegenerative diseases may lead to the introduction of new competitors. However, its established track record and regulatory approvals provide a strong foundation for its market position.

Clinical and Economic Impact

Diagnostic Accuracy

Flortaucipir F-18 has demonstrated high sensitivity and specificity in identifying Braak stages of NFT pathology, which is crucial for the accurate diagnosis and staging of Alzheimer’s disease. This accuracy can lead to better treatment planning and patient management[5].

Economic Benefits

The economic impact of flortaucipir F-18 extends beyond its direct revenue. By enabling early diagnosis and potentially delaying disease progression, it can reduce the overall economic burden of Alzheimer’s disease on healthcare systems.

Challenges and Opportunities

Regulatory Monitoring

As with all medicines, the use of flortaucipir F-18 is continuously monitored for suspected side effects. This ongoing evaluation is essential for ensuring patient safety and maintaining regulatory approvals[4].

Expanding Indications

While flortaucipir F-18 is currently indicated for Alzheimer’s disease, there is potential for its use in other neurodegenerative conditions. Research into these areas could expand its market and increase its financial trajectory.

Key Takeaways

• Regulatory Approvals: Flortaucipir F-18 has received FDA approval and EU marketing authorization, ensuring broad market access.
• Market Demand: The drug addresses a significant clinical need for accurate Alzheimer’s disease diagnostics, driving its adoption in clinical settings.
• Pricing and Reimbursement: Medicaid and other healthcare programs cover the drug, with a defined reimbursement rate, making it more accessible.
• Financial Trajectory: Expected to generate substantial revenue due to its unique positioning and growing demand.
• Competitive Landscape: Currently the only FDA-approved tau PET tracer, with a strong market position but potential for future competition.
• Clinical and Economic Impact: High diagnostic accuracy and potential economic benefits through early diagnosis and better patient management.

FAQs

What is flortaucipir F-18 used for?

Flortaucipir F-18 is used in positron emission tomography (PET) imaging to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients being evaluated for Alzheimer’s disease[3].

How is flortaucipir F-18 administered?

Flortaucipir F-18 is administered as an intravenous bolus injection, with a recommended dose of 370 MBq (10 mCi)[2].

Is flortaucipir F-18 covered by Medicaid?

Yes, Medicaid and NC Health Choice programs cover flortaucipir F-18 injections, effective March 6, 2023, under the HCPCS code A9601[2].

What are the key benefits of using flortaucipir F-18?

The key benefits include high diagnostic accuracy, the ability to visualize NFTs in vivo, and potential economic benefits through early diagnosis and better patient management[5].

Are there any potential side effects of flortaucipir F-18?

As with all medicines, the use of flortaucipir F-18 is continuously monitored for suspected side effects, which are carefully evaluated to protect patients[4].

Sources

1. Michael J. Pontecorvo et al., "A multicentre longitudinal study of flortaucipir (18F) in normal ageing, mild cognitive impairment and Alzheimer's disease dementia," Brain, 2019.
2. NC Medicaid, "Flortaucipir F 18 Injection, for Intravenous Use (Tauvid™) HCPCS Code A9601," May 31, 2023.
3. DrugBank, "Flortaucipir F-18: Uses, Interactions, Mechanism of Action," DB14914.
4. European Medicines Agency, "Tauvid | European Medicines Agency (EMA)," June 28, 2024.
5. Academic.oup.com, "Review of the flortaucipir literature for positron emission tomography imaging of neurofibrillary tau tangles," Brain Communications, November 16, 2023.