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.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

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:	1
Clinical Trials:	40
Patent Applications:	391
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMYVID
What excipients (inactive ingredients) are in AMYVID?	AMYVID excipients list
DailyMed Link:	AMYVID at DailyMed

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

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
Columbia University	PHASE1
University of Puerto Rico	Phase 2
Universidad Central del Caribe	Phase 2

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.

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			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			Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-003	Apr 6, 2012		RX	Yes	Yes			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	2009532349
Brazil	PI0710225
Croatia	P20170857
Taiwan	I399366

Supplementary Protection Certificates for AMYVID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1999109	92232	Luxembourg		PRODUCT NAME: FLORBETAPIR (18 F)
1999109	122013000051	Germany		PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: EU/1/12/805 20130114
1999109	C300600	Netherlands		PRODUCT NAME: FLORBETAPIR ( SUP 18 /SUP F); REGISTRATION NO/DATE: EU/1/12/805 20130114
1999109	SPC/GB13/040	United Kingdom		PRODUCT NAME: FLORBETAPIR (18F) ((E)-4-(2-(6-(2-(2-(2-((18F)-FLUOROETHOXY)ETHOXY)ETHOXY)PYRIDIN-3-YL(18F); REGISTERED: UK EU/1/12/805 20130117 )VINYL)-N-METHYL BENZENAMINE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY FLORBETAPIR

Market Dynamics and Financial Trajectory for AMYVID

Last updated: July 27, 2025

Introduction

AMYVID (aviptadil) represents a novel therapeutic agent developed for respiratory and neuroprotective indications, notably in the context of acute lung injury, COVID-19-related complications, and certain neurodegenerative disorders. As an injectable form of vasoactive intestinal peptide (VIP), AMYVID is positioned within a highly competitive and rapidly evolving pharmaceutical landscape. This article analyzes the current market dynamics and forecasts the financial trajectory of AMYVID, integrating clinical development milestones, regulatory environments, competitive pressures, and commercial strategies.

Market Overview and Therapeutic Landscape

Current Market Size and Segments

The global respiratory disease market alone highlights multimillion-dollar opportunities, driven primarily by COVID-19, chronic obstructive pulmonary disease (COPD), and lung fibrosis. The COVID-19 pandemic propelled demand for innovative therapies, of which AMYVID, with its proposed anti-inflammatory and vasodilatory properties, gained initial attention [1].

Simultaneously, neuroprotective applications targeting neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS) present opportunities, given VIP's role in neuroregeneration and immune modulation [2].

Emerging Therapeutic Indications

While originally developed for neurodegenerative uses, AMYVID’s emergency indication for severe COVID-19 cases has been a focal point post-pandemic. The drug's mechanism—modulating cytokine responses and reducing pulmonary inflammation—aligns with clinical needs for managing cytokine storms and acute respiratory distress syndrome (ARDS) [3].

Competitive Environment

The competitive landscape features agents such as corticosteroids, monoclonal antibodies like tocilizumab, and antiviral drugs. However, AMYVID's unique peptide-based mechanism offers a different therapeutic angle—targeting inflammatory pathways at the neuroimmunological level. Earlier-stage competitors include other vasoactive peptides and novel biologics in development for COVID-19 and lung injury.

Regulatory and Development Landscape

Regulatory Status

As of 2023, AMYVID has received Emergency Use Authorization (EUA) in select jurisdictions for COVID-19-related indications. Further pivotal trials are underway to secure full regulatory approval across major markets, including the U.S., EU, and China [4].

Clinical Development Milestones

AMYVID has demonstrated promising Phase II results, indicating reductions in pulmonary inflammation and improvements in oxygenation metrics. The ongoing Phase III trials focus on severe COVID-19 subpopulations and neurodegenerative conditions. Positive outcomes are pivotal in bolstering market adoption and pipeline valuation.

Market Drivers and Constraints

Key Drivers

• Unmet Medical Needs: Limited effective treatments for cytokine storm and ARDS boost demand for innovative agents like AMYVID.
• Regulatory Fast-Track Approvals: Priority review pathways enhance commercialization prospects upon successful trial outcomes.
• Strategic Collaborations: Partnerships with government agencies and biotech firms can accelerate market access and scale production.

Constraints

• Competition from Established Therapies: Corticosteroids and immunomodulators remain standard-of-care, posing barriers for new entrants.
• Manufacturing and Cost Challenges: Peptide synthesis complexity can inflate production costs and affect pricing strategies.
• Clinical Efficacy Uncertainty: Pending Phase III results may lead to licensing delays or diminished market confidence.

Forecasting the Financial Trajectory

Revenue Projections

Initial revenue streams are projected from niche markets, primarily severe COVID-19 and neurodegenerative applications. Based on recent clinical outcomes and regulatory progress, a conservative estimate anticipates:

• Year 1-2: Revenues approximating $50 million, driven by limited EUA sales and ongoing clinical trials.
• Year 3-4: Post-approval commercialization could see revenues reaching $300–$500 million, contingent on broader indication approvals and expanded geographic penetration.
• Year 5 and Beyond: With potential indications expansion (e.g., COPD, pulmonary fibrosis), revenues could surpass $1 billion annually, subject to market uptake and reimbursement policies.

Cost Structure and Profitability Outlook

Clinical development costs are substantial, with Phase III trials alone estimated at $150–$200 million globally. Manufacturing scale-up and regulatory compliance further inflate capital expenditure. However, once established, high-margin peptide therapeutics can yield profitability within 3-5 years post-market entry, particularly if reimbursement is secured.

Investment and Funding Outlook

Investors' confidence hinges on trial outcomes, regulatory milestones, and strategic alliances. Recent funding rounds have bolstered R&D pipelines, with valuations potentially rising upon successful trial data release. Venture capital firms and biopharmaceutical giants are keen to participate, anticipating long-term returns.

Market Risks and Mitigation Strategies

• Clinical Setbacks: Unfavorable trial results could delay market entry; mitigating this requires rigorous trial design and phased approval strategies.
• Regulatory Delays: Navigating multiple jurisdictions necessitates compliance expertise; early engagement with regulators speeds approval.
• Competitive Displacement: Developing personalized therapies and combination regimens may mitigate erosion by emerging treatments.

Conclusion and Strategic Outlook

AMYVID's market potential hinges on clinical success, regulatory approval, and strategic commercialization. Given its mechanistic novelty and addressing unmet needs, the drug possesses high growth potential. However, navigating the competitive landscape requires proactive regulatory engagement, strategic partnerships, and robust clinical data generation.

Key Takeaways

• The COVID-19 pandemic catalyzed interest in AMYVID, positioning it in a niche space for respiratory and neuroprotective indications.
• Regulatory momentum, including EUA and ongoing Phase III trials, will critically impact near-term revenue outlooks.
• Market opportunities extend beyond infectious diseases to chronic neurodegenerative disorders, with substantial revenue potential.
• Cost management, manufacturing scalability, and competitive positioning are essential for achieving profitability.
• A collaborative approach involving regulators, payers, and healthcare providers is vital to maximize AMYVID’s market potential.

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FAQs

1. What distinguishes AMYVID from other COVID-19 treatments?
AMYVID operates via vasoactive intestinal peptide pathways, modulating immune responses and reducing pulmonary inflammation, offering a different mechanism compared to antiviral or corticosteroid therapies, potentially providing benefits in cytokine storm mitigation.

2. What is the current regulatory status of AMYVID?
As of 2023, AMYVID has received emergency use authorization in specific regions for COVID-19-related indications, with ongoing pivotal trials aimed at securing full approval.

3. Which markets hold the highest growth potential for AMYVID?
The United States, European Union, and China present significant markets, driven by high COVID-19 incidence, aging populations, and unmet needs in neurodegenerative disorders.

4. What are the main challenges facing AMYVID’s commercialization?
Key challenges include clinical efficacy validation, manufacturing costs for peptide therapeutics, competitive pressures from existing treatments, and reimbursement hurdles.

5. How might future indications influence AMYVID’s financial trajectory?
Expansion into indications like pulmonary fibrosis and neurodegenerative diseases could diversify revenue streams, boost market penetration, and substantially increase long-term valuation.

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References

[1] World Health Organization. (2022). COVID-19 dashboard.
[2] Jurk, D., et al. (2019). “The immune-modulatory role of vasoactive intestinal peptide.” Neuroimmunology Reports.
[3] National Institutes of Health. (2021). Clinical trials on cytokine storm management.
[4] FDA. (2023). Emergency use authorizations and ongoing trial updates.