AMMONIA N-13 - Generic Drug Details

What are the generic drug sources for ammonia n-13 and what is the scope of freedom to operate?

Ammonia n-13 is the generic ingredient in one branded drug marketed by 3d Imaging Drug, Biomedcl Res Fdn, Brigham Womens Hosp, Cardinal Hlth 414, Central Radiopharm, Decatur, Essential Isotopes, Feinstein, Gen Hosp, Ionetix, Johns Hopkins Univ, Kreitchman Pet Ctr, Mcprf, Methodist, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Nukemed, Petnet, Precision Nuclear, Shertech Labs Llc, Sofie, Ucla Biomedical, Ucsf Rodiopharm, Univ Alahama Birm, Univ Tx Md Anderson, Univ Tx Sw Medctr, Univ Wisconsin, Wa Univ Sch Med, and Wisconsin, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

Twenty suppliers are listed for this compound.

Summary for AMMONIA N-13

US Patents:	0
Tradenames:	1
Applicants:	30
NDAs:	31
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	103
Patent Applications:	1,728
What excipients (inactive ingredients) are in AMMONIA N-13?	AMMONIA N-13 excipients list
DailyMed Link:	AMMONIA N-13 at DailyMed

Recent Clinical Trials for AMMONIA N-13

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

Sponsor	Phase
Khyber Medical College, Peshawar	Phase 4
Cairo University	Phase 3
CBmed Ges.m.b.H.	Phase 4

See all AMMONIA N-13 clinical trials

Pharmacology for AMMONIA N-13

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

US Patents and Regulatory Information for AMMONIA N-13

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Midwest Medcl	AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	204457-001	Nov 18, 2015	AP	RX	No	No
Methodist	AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	215083-001	Jul 9, 2021	AP	RX	No	No
Cardinal Hlth 414	AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	203700-001	Feb 25, 2013	AP	RX	No	No

AMMONIA N-13 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ammonia N-13

Introduction

Ammonia N-13, a radiopharmaceutical used primarily in Positron Emission Tomography (PET) imaging, is experiencing significant growth driven by its applications in medical diagnostics. Here, we delve into the market dynamics and financial trajectory of Ammonia N-13.

Market Size and Growth

The global Ammonia N-13 market is projected to witness exponential growth, with a Compound Annual Growth Rate (CAGR) of approximately 7.8% from 2024 to 2033. This growth is largely driven by the increasing demand for advanced medical imaging technologies, particularly in the diagnosis of cardiovascular and neurological disorders[1].

Key Drivers

Several factors are driving the growth of the Ammonia N-13 market:

Increasing Prevalence of Cardiovascular and Neurological Disorders

The rising incidence of cardiovascular diseases such as coronary artery disease, myocardial infarction, and heart failure, along with neurological disorders like Alzheimer's and Parkinson's disease, has significantly boosted the demand for Ammonia N-13-based PET imaging. This diagnostic tool is invaluable for early detection and effective management of these conditions[1].

Advanced Medical Imaging Techniques

The growing demand for advanced and non-invasive diagnostic tools has made Ammonia N-13 a preferred choice. Its superior image quality, high spatial and contrast resolution, and high first-pass extraction and retention in the myocardium make it an optimal tracer for myocardial perfusion imaging[2].

Regulatory Approvals

FDA approval and reimbursement by Medicare and most private payers have contributed to the market's growth and acceptance among healthcare providers. This regulatory support has enhanced the financial viability of Cardiac PET programs using Ammonia N-13[2].

Competitive Landscape

The Ammonia N-13 market is characterized by a competitive landscape with both established pharmaceutical and medical imaging companies, such as GE Healthcare, Siemens Healthineers, and Bracco Imaging, as well as specialized radiopharmaceutical manufacturers. These companies are focused on product development, strategic partnerships, and geographic expansion to strengthen their market position[1].

Market Opportunities

Emerging Markets

The Latin American and Middle East and Africa regions are witnessing a growing interest in Ammonia N-13-based PET imaging as these regions invest in healthcare infrastructure and adopt advanced medical technologies. Although market penetration in these regions is currently lower compared to North America and Europe, they present significant opportunities for market expansion[1].

Technological Advancements

Ongoing research and development activities aim to improve production techniques, increase availability, and enhance the safety and efficacy of Ammonia N-13 radiopharmaceuticals. These advancements will make Ammonia N-13-based PET imaging more accessible and affordable, further driving market growth[1].

Production and Distribution

The production of Ammonia N-13 involves complex processes due to its short half-life of 9.96 minutes. However, recent advancements have led to the development of reliable semi-automated production systems that can manufacture large quantities of high-purity Ammonia N-13. These systems have proven to be easy to operate and maintain, ensuring consistent supply and compliance with FDA/USP specifications[4].

Financial Viability

Reimbursement

Reimbursement is a critical factor in the financial viability of Cardiac PET programs. Since Ammonia N-13 is FDA-approved and reimbursed by Medicare and most private payers, it supports the economic sustainability of these programs. Companies like IONETIX also provide assistance in navigating the reimbursement process, further enhancing financial stability[2].

Market Expansion

The expansion into emerging economies, particularly in the Asia-Pacific and Latin American regions, presents significant financial opportunities. As these regions invest in healthcare infrastructure and adopt advanced medical technologies, the demand for Ammonia N-13 is expected to increase, contributing to the market's financial growth[1].

Clinical Impact and Prognostic Value

Diagnostic Accuracy

Ammonia N-13-based PET imaging has proven to be highly accurate in diagnosing cardiovascular and neurological conditions. It provides superior image quality and is particularly effective in assessing myocardial perfusion and detecting coronary artery disease. This diagnostic accuracy translates into better patient management and outcomes[2].

Long-term Prognosis

Studies have shown that perfusion findings in Ammonia N-13 PET imaging, combined with coronary flow reserve (CFR), are strong predictors of long-term cardiac outcomes. This predictive value allows for better risk stratification and management of patients, further solidifying the clinical and financial importance of Ammonia N-13[5].

Future Outlook

The future outlook for the Ammonia N-13 market is positive, driven by the increasing prevalence of cardiovascular and neurological disorders, the growing demand for advanced medical imaging techniques, and ongoing advancements in production and distribution. As healthcare infrastructure expands globally, the market is expected to continue its growth trajectory, offering substantial financial opportunities for market players[1].

Key Takeaways

• The Ammonia N-13 market is expected to grow at a CAGR of approximately 7.8% from 2024 to 2033.
• Increasing demand for advanced medical imaging techniques and the rising incidence of cardiovascular and neurological disorders are key drivers.
• Regulatory approvals and reimbursement support the market's growth.
• Emerging markets and technological advancements present significant opportunities.
• The production of Ammonia N-13 is complex but has been improved by reliable semi-automated systems.
• The financial viability is supported by reimbursement and market expansion into emerging economies.
• Ammonia N-13-based PET imaging has high diagnostic accuracy and prognostic value.

FAQs

What is the primary use of Ammonia N-13 in medical diagnostics?

Ammonia N-13 is primarily used in Positron Emission Tomography (PET) imaging for the assessment of myocardial perfusion, detection of coronary artery disease, and evaluation of various neurological disorders.

What drives the growth of the Ammonia N-13 market?

The growth of the Ammonia N-13 market is driven by the increasing prevalence of cardiovascular and neurological disorders, the growing demand for advanced medical imaging techniques, and ongoing advancements in production and distribution.

Is Ammonia N-13 reimbursed by healthcare providers?

Yes, Ammonia N-13 is FDA-approved and reimbursed by Medicare and most private payers, which is critical for the financial viability of Cardiac PET programs.

What are the challenges in producing Ammonia N-13?

The production of Ammonia N-13 is challenging due to its short half-life of 9.96 minutes. However, recent advancements have led to the development of reliable semi-automated production systems.

How does Ammonia N-13 contribute to long-term prognosis?

Ammonia N-13-based PET imaging, combined with coronary flow reserve (CFR), is a strong predictor of long-term cardiac outcomes, allowing for better risk stratification and patient management.

Sources

1. DataHorizon Research: Ammonia N 13 Market Size, Share, Growth, Statistics Report 2033.
2. Ionetix: N-13 Ammonia: Advanced Cardiac PET Imaging.
3. KBV Research: Ammonia Market Size, Trends Analysis & Forecast to 2023-2030.
4. MDPI: A Reliable Production System of Large Quantities of [13N]Ammonia.
5. ZORA: Long-term prognostic value of N-Ammonia myocardial perfusion PET.