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Last Updated: December 22, 2024

AMMONIA N 13 Drug Patent Profile


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Which patents cover Ammonia N 13, and when can generic versions of Ammonia N 13 launch?

Ammonia N 13 is a 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.

The generic ingredient in AMMONIA N 13 is ammonia n-13. There are two drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ammonia n-13 profile page.

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Summary for AMMONIA N 13
US Patents:0
Applicants:30
NDAs:31
Finished Product Suppliers / Packagers: 20
Raw Ingredient (Bulk) Api Vendors: 4
Clinical Trials: 103
Patent Applications: 829
What excipients (inactive ingredients) are in AMMONIA N 13?AMMONIA N 13 excipients list
DailyMed Link:AMMONIA N 13 at DailyMed
Drug patent expirations by year for AMMONIA N 13
Recent Clinical Trials for AMMONIA N 13

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

SponsorPhase
Khyber Medical College, PeshawarPhase 4
Cairo UniversityPhase 3
Medical University of GrazPhase 4

See all AMMONIA N 13 clinical trials

Pharmacology for AMMONIA N 13

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
Univ Tx Sw Medctr AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 209507-001 Nov 1, 2019 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Univ Wisconsin AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 211740-001 Sep 9, 2020 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
3d Imaging Drug AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 203779-001 Oct 19, 2015 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Nukemed AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 204455-001 Apr 23, 2015 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ucla Biomedical AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 203812-001 Jun 27, 2013 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

AMMONIA N 13 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ammonia N 13

Market Overview

The global Ammonia N 13 market is a segment of the broader radiopharmaceutical industry, specifically focused on Positron Emission Tomography (PET) imaging. This market is driven by the increasing demand for advanced medical imaging technologies, particularly in the diagnosis and management of cardiovascular and neurological disorders.

Market Size and Growth

The Ammonia N 13 market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 7.8% during the forecast period, driven by the rising prevalence of cardiovascular and neurological diseases[1].

Key Drivers

  • Increasing Prevalence of Cardiovascular Diseases: The growing incidence of coronary artery disease, myocardial infarction, and heart failure has significantly contributed to the market's growth. Ammonia N 13-based PET imaging is a valuable tool in assessing myocardial perfusion, enabling early diagnosis and effective management of these conditions[1].
  • Growing Demand for Advanced Medical Imaging: The need for more accurate and non-invasive diagnostic tools has increased the demand for Ammonia N 13-based PET imaging. This is particularly evident in the assessment of myocardial perfusion and the evaluation of neurological disorders such as Alzheimer's disease and Parkinson's disease[1].
  • Advancements in Production and Distribution: Ongoing research and development activities aimed at improving production techniques, increasing availability, and enhancing the safety and efficacy of Ammonia N 13 radiopharmaceuticals are also driving market growth[1].

Market Opportunities

  • Emerging Regions: The Asia-Pacific region is poised to experience the highest growth rate during the forecast period, driven by rising healthcare awareness, a growing middle-class population, and increasing investments in healthcare infrastructure in countries like China, Japan, and India[1].
  • Expanding Applications: The use of Ammonia N 13 in the evaluation of neurological disorders offers substantial growth potential. As healthcare providers seek advanced imaging techniques for early detection and effective management of these conditions, the demand for Ammonia N 13-based PET imaging is expected to increase[1].

Competitive Landscape

The market is characterized by the presence of both established players, such as GE Healthcare and Siemens Healthineers, and specialized radiopharmaceutical manufacturers. This competitive landscape drives innovation and improves the quality and accessibility of Ammonia N 13 radiopharmaceuticals[1].

Regulatory Environment

Regulatory approvals, such as the FDA approval of Ammonia N 13 for use in PET imaging, have significantly contributed to the market's growth and acceptance among healthcare providers. These approvals ensure the safety and efficacy of the radiopharmaceutical, enhancing its adoption[1][5].

Regional Analysis

  • North America: Currently the largest market, driven by a well-established healthcare infrastructure, the presence of key market players, and a favorable regulatory environment[1].
  • Europe: A significant market with growing adoption in countries such as Germany, the UK, and France, driven by the increasing prevalence of cardiovascular and neurological disorders[1].
  • Asia-Pacific: Expected to experience the highest growth rate, driven by rising healthcare awareness and investments in healthcare infrastructure[1].

Financial Trajectory

The financial trajectory of the Ammonia N 13 market is positive, with projected growth driven by increasing demand and advancements in technology.

  • Revenue Growth: The market is expected to continue its growth trajectory, driven by the increasing prevalence of cardiovascular and neurological disorders and the growing demand for advanced medical imaging techniques[1].
  • Investments and R&D: Ongoing investments in research and development to improve production techniques, increase availability, and enhance safety and efficacy are expected to contribute to the market's financial growth[1].

Challenges and Considerations

  • Radiation Risks: Ammonia N 13 Injection may increase the risk of cancer, necessitating the use of the smallest dose necessary for imaging and ensuring safe handling to protect patients and healthcare workers[5].
  • Regulatory Compliance: Market players must comply with stringent regulatory requirements to ensure the safety and efficacy of Ammonia N 13 radiopharmaceuticals[1].

Future Outlook

The future outlook for the Ammonia N 13 market is promising, with continued growth expected due to the increasing prevalence of cardiovascular and neurological disorders and the ongoing advancements in production and distribution.

  • Expansion into Emerging Economies: The market is expected to expand into emerging economies, particularly in the Asia-Pacific and Latin American regions, presenting significant opportunities for market players[1].
  • Technological Advancements: Improvements in manufacturing processes, supply chain management, and cost optimization will enhance the accessibility and affordability of Ammonia N 13-based PET imaging, making it more widely available to healthcare providers and patients[1].

Key Takeaways

  • The Ammonia N 13 market is growing at a CAGR of approximately 7.8%, driven by the increasing demand for advanced medical imaging technologies.
  • The market is driven by the rising prevalence of cardiovascular and neurological diseases.
  • Regulatory approvals and ongoing R&D activities are key factors contributing to market growth.
  • The Asia-Pacific region is expected to experience the highest growth rate during the forecast period.
  • The market faces challenges such as radiation risks and the need for regulatory compliance.

FAQs

Q: What is Ammonia N 13 used for? A: Ammonia N 13 is used for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease[4][5].

Q: What are the key drivers of the Ammonia N 13 market? A: The key drivers include the increasing prevalence of cardiovascular and neurological diseases, the growing demand for advanced medical imaging techniques, and ongoing advancements in production and distribution[1].

Q: Which regions are expected to experience significant growth in the Ammonia N 13 market? A: The Asia-Pacific region is expected to experience the highest growth rate, followed by North America and Europe[1].

Q: What are the regulatory considerations for Ammonia N 13? A: Ammonia N 13 has received FDA approval for use in PET imaging, and market players must comply with stringent regulatory requirements to ensure safety and efficacy[1][5].

Q: What are the potential risks associated with Ammonia N 13? A: Ammonia N 13 may increase the risk of cancer, and safe handling practices are necessary to protect patients and healthcare workers[5].

Cited Sources

  1. DataHorizzon Research: Ammonia N 13 Market Size, Share, Growth, Statistics Report 2033.
  2. FDA: Ammonia N 13 Injection for intravenous use.
  3. KBV Research: Ammonia Market Size, Trends Analysis & Forecast to 2023-2030.
  4. DrugBank: Ammonia N-13: Uses, Interactions, Mechanism of Action.
  5. Siemens Healthineers: Ammonia N 13 Injection.

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