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AMYVID Drug Patent Profile

When do Amyvid patents expire, and what generic alternatives are available?

Amyvid is a drug marketed by Avid Radiopharms Inc and is included in one NDA. There are two patents protecting this drug.

This drug has fifty-one patent family members in thirty-three countries.

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

DrugPatentWatch^® Generic Entry Outlook for Amyvid

Amyvid was eligible for patent challenges on April 6, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 30, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AMYVID

International Patents:	51
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	39
Patent Applications:	160
What excipients (inactive ingredients) are in AMYVID?	AMYVID excipients list
DailyMed Link:	AMYVID at DailyMed

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

Constraining patent/regulatory exclusivity:

7,687,052

NDA:

202008

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 AMYVID

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

Sponsor	Phase
University of Puerto Rico	Phase 2
Universidad Central del Caribe	Phase 2
Invicro	Phase 1

See all AMYVID clinical trials

Pharmacology for AMYVID

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for AMYVID

AMYVID is protected by two US patents.

This potential generic entry date is based on patent 7,687,052.

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	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-001	Apr 6, 2012		DISCN	Yes	No	8,506,929		Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-003	Apr 6, 2012		RX	Yes	Yes	7,687,052		Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-002	Apr 6, 2012		DISCN	Yes	No	8,506,929		Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-001	Apr 6, 2012		DISCN	Yes	No	7,687,052		Y	Y

International Patents for AMYVID

When does loss-of-exclusivity occur for AMYVID?

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

Australia

Austria

Brazil

Canada

China

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

France

Guatemala

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

New Zealand

Norway

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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 AMYVID around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5290954
Norway	2018030
Cyprus	1119048
New Zealand	570887	Styrylpyridine derivatives and their use for binding and imaging amyloid plaques

Supplementary Protection Certificates for AMYVID

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
1999109	C20130016 00076	Estonia		PRODUCT NAME: FLORBETAPIIR (18F);REG NO/DATE: K(2013)137 (LOPLIK) 14.01.2013

AMYVID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amyvid

Introduction

Amyvid, also known as Florbetapir F 18 Injection, is a groundbreaking diagnostic agent approved by the FDA in 2012 for the detection of beta-amyloid plaques in the brains of patients with cognitive impairment, particularly those being evaluated for Alzheimer's Disease and other causes of cognitive decline. Here, we delve into the market dynamics and financial trajectory of Amyvid.

FDA Approval and Regulatory Environment

The FDA approval of Amyvid marked a significant milestone in the diagnosis of Alzheimer's Disease. It is the first and only radioactive diagnostic agent approved for PET imaging of beta-amyloid neuritic plaques in the living brain[1][4].

Market Need and Demand

Alzheimer's Disease is a growing health concern, affecting millions worldwide. The need for accurate and early diagnosis is paramount, and Amyvid fills this gap by providing a tool for clinicians to visualize amyloid plaques, a hallmark of Alzheimer's[1].

Distribution and Manufacturing

Given its radioactive nature, Amyvid loses over half of its radioactivity every two hours, necessitating a robust distribution network. Cardinal Health plays a crucial role in manufacturing and distributing Amyvid, leveraging its extensive network of radiopharmacies to reach over 90% of U.S. hospitals within three hours[4].

Commercial Launch and Expansion

The commercial launch of Amyvid began in June 2012, with initial distribution from seven sites in the U.S. and plans to expand to 12 locations by the end of that year. This strategic rollout ensured widespread accessibility to the diagnostic agent[4].

Financial Impact on Eli Lilly

Eli Lilly, the developer of Amyvid, has seen significant financial implications from the drug's approval and distribution. While specific revenue figures for Amyvid are not isolated in public reports, the overall revenue and profitability of Eli Lilly's neuroscience segment have been influenced by the drug's market presence.

Revenue Contribution

Amyvid contributes to Eli Lilly's revenue, although it is part of a broader portfolio. The company's overall revenue growth, particularly in the neuroscience segment, reflects the impact of innovative products like Amyvid[5].

Operational Costs

The manufacturing and distribution of Amyvid involve substantial operational costs, including the maintenance of a sophisticated radiopharmaceutical manufacturing infrastructure and a comprehensive logistics network. These costs are factored into Eli Lilly's overall operational expenses[4].

Market Competition and Landscape

The Alzheimer's diagnostic and therapeutic market is evolving rapidly. Amyvid faces competition from other diagnostic tools and emerging therapies. For instance, the FDA's recent approval of anti-amyloid therapies like Leqembi and the ongoing review of donanemab indicate a dynamic market landscape[3].

Pricing and Reimbursement

The pricing of Amyvid is critical to its market success. Given its innovative nature and the specialized distribution requirements, the drug is likely priced at a premium. Reimbursement policies by healthcare providers and insurance companies also play a significant role in its adoption and financial performance.

Future Outlook and Expansion

As research in Alzheimer's Disease advances, the demand for diagnostic tools like Amyvid is expected to grow. The integration of Amyvid into clinical trials, such as the TRAILBLAZER-ALZ 2 trial for donanemab, highlights its ongoing relevance in the field[3].

Combination Therapies

The future of Alzheimer's treatment may involve combination therapies, where amyloid-clearing drugs like those being developed by Eli Lilly are used in conjunction with other novel therapies. This approach could further enhance the market for diagnostic agents like Amyvid[3].

Financial Performance Metrics

While detailed financial metrics specific to Amyvid are not publicly disclosed, the overall financial performance of Eli Lilly and its neuroscience segment provides insights into the drug's impact.

• Revenue Growth: Eli Lilly's revenue has seen growth, partly attributed to innovative products in its neuroscience portfolio, including Amyvid[5].
• Operational EBITDA: The company's operational EBITDA margins reflect the efficiency and profitability of its operations, including the distribution and sales of Amyvid[5].

Challenges and Opportunities

Regulatory Challenges

The regulatory environment remains a significant factor. The FDA's rigorous approval process and ongoing reviews, such as the advisory committee meeting for donanemab, underscore the challenges and opportunities in this market[3].

Market Expansion

The potential for expanding Amyvid's availability to more markets and regions presents a significant opportunity for growth. Cardinal Health's extensive distribution network is pivotal in this expansion[4].

Key Takeaways

• Innovative Diagnostic Tool: Amyvid is the first FDA-approved radioactive diagnostic agent for PET imaging of beta-amyloid plaques.
• Market Demand: The growing need for early and accurate Alzheimer's diagnosis drives demand for Amyvid.
• Distribution and Manufacturing: Cardinal Health's role is crucial in ensuring the drug's availability.
• Financial Impact: Amyvid contributes to Eli Lilly's revenue and operational costs, influencing the company's financial performance.
• Future Outlook: The drug's integration into combination therapies and ongoing clinical trials ensures its relevance in the evolving Alzheimer's treatment landscape.

FAQs

Q: What is Amyvid used for?

A: Amyvid is used for the PET imaging of beta-amyloid neuritic plaques in the brains of patients with cognitive impairment, particularly those being evaluated for Alzheimer's Disease and other causes of cognitive decline.

Q: Who manufactures and distributes Amyvid?

A: Amyvid is manufactured and distributed by Cardinal Health, leveraging its extensive network of radiopharmacies.

Q: How does Amyvid's radioactivity affect its distribution?

A: Amyvid loses over half of its radioactivity every two hours, requiring it to be distributed directly from radiopharmacies to imaging centers within a short timeframe.

Q: What is the current market landscape for Alzheimer's diagnostics and therapies?

A: The market is dynamic, with emerging therapies like Leqembi and ongoing reviews of new drugs like donanemab, indicating a growing and competitive field.

Q: How does Amyvid fit into future Alzheimer's treatment strategies?

A: Amyvid is expected to play a role in combination therapies, where it will be used alongside other novel treatments to provide a precision medicine approach for Alzheimer's patients.

Sources

1. FDA Approves Amyvid™ (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline. PR Newswire.
2. Unaudited Group interim results for the six months ended 31 March 2023. Life Healthcare.
3. Alzheimer's Drug Discovery Foundation (ADDF) Statement on FDA Decision to Convene Advisory Committee for Donanemab. BioSpace.
4. Cardinal Health to Manufacture, Distribute Eli Lilly and Company's New Diagnostic Imaging Agent Amyvid. Cardinal Health Newsroom.
5. 2024 Revenue - Eli Lilly Investors. Eli Lilly Investor Relations.