AMMONIA N 13 Drug Patent Profile

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, 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. Nineteen suppliers are listed for this compound. Additional details are available on the ammonia n-13 profile page.

Summary for AMMONIA N 13

US Patents:	0
Applicants:	29
NDAs:	31
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	116
Patent Applications:	1,650
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
Mansoura University	PHASE4
Universit de Montral	PHASE4
Université de Sherbrooke	PHASE2

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
Univ Tx Sw Medctr	AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	209507-001	Nov 1, 2019	AP	RX	No	No
Univ Wisconsin	AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	211740-001	Sep 9, 2020	AP	RX	No	No
3d Imaging Drug	AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	203779-001	Oct 19, 2015	AP	RX	No	No
Petnet	AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	204510-001	Nov 2, 2015	AP	RX	No	No
Ucla Biomedical	AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	203812-001	Jun 27, 2013	AP	RX	No	No
Feinstein	AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	022119-001	Aug 23, 2007	AP	RX	Yes	Yes
Cardinal Hlth 414	AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	203700-001	Feb 25, 2013	AP	RX	No	No

Market Dynamics and Financial Trajectory for Ammonia N-13

Last updated: February 20, 2026

What is Ammonia N-13?

Ammonia N-13, or nitrogen-13 labeled ammonia, is a radiotracer used primarily in positron emission tomography (PET) scans to evaluate myocardial perfusion and viability. Its half-life is approximately 10 minutes, necessitating on-site cyclotron production.

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Market Fundamentals

Supply Chain Overview

• Production Source: Cyclotrons generate N-13 amid high operational costs and specialized infrastructure.
• Distribution: Limited to facilities with cyclotrons or access via specialized suppliers.
• Regulatory Environment: Requires adherence to radiation safety, import/export controls, and approval from agencies such as the FDA (U.S.) or EMA (Europe).

Key Markets and Adoption Factors

• Geographic Adoption: Highest in North America and Europe; Asia-Pacific exhibits growth potential.
• Clinical Demand Drivers: Rising prevalence of cardiovascular diseases (CVD), advancements in PET imaging technologies, and increasing clinical research.

Competitive Landscape

• Major Players: Thermo Fisher Scientific, Bracco Diagnostics, and certain regional providers manage N-13 production and distribution.
• Alternatives: Rubidium-82 is gaining popularity for myocardial imaging, impacting N-13's market share.

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Market Trends

Trend	Impact	Evidence
Growing CVD prevalence	Increases demand for myocardial PET tracers	WHO reports CVD as leading cause of death globally [1]
Technological advancements	Enhances diagnostic accuracy and broadens use cases	PET scanner improvements expanding clinical scope [2]
Regulatory firings and approvals	Facilitates region-wise market expansion	FDA approval pathways for new tracers [3]
Competition from alternative tracers	Limits N-13 market growth in some segments	Rubidium-82 availability increasing [4]

Pricing Trends

• Unit Cost: Typically ranges from $1,200 to $2,500 per dose owing to cyclotron maintenance and production complexity.
• Reimbursement: Varies; in the U.S., Medicare covers PET myocardial perfusion with specific guidelines (CPT 78999), influencing uptake.

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Financial Trajectory and Investment Outlook

Revenue Projections

• Current Market Size: Estimated at $50–70 million globally in 2022.
• Compound Annual Growth Rate (CAGR): Expected at 4%-6% over the next five years, driven by aging populations and technological adoption.
• Regional Growth: North America dominates, with Europe following; Asia-Pacific shows 7% CAGR due to expanding healthcare infrastructure.

Cost and Investment Considerations

• Production Costs: High initial capital investment in cyclotron facilities; ongoing operational costs are significant.
• Market Entry Barriers: Require regulatory approval, technical expertise, and compliance with radiation safety standards.
• Partnership Opportunities: Collaborations with hospitals, research centers, and pharmaceutical companies foster growth.

Funding and R&D Trends

• Increased funding from government health agencies and private investors for radiopharmaceutical development.
• Emerging research on enhanced tracers and alternative delivery systems.

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Regulatory and Market Challenges

Challenge	Impact
Short half-life constraints	Limits distribution radius and complicates logistics
Regulatory complexity	Extends approval timelines and increases costs
Competition from alternative tracers	Diminishes market share and pricing power

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Key Takeaways

• Market size remains modest but steady, driven by clinical demand for myocardial perfusion imaging.
• Growth prospects depend heavily on regulatory developments, technological advancements, and regional healthcare infrastructure.
• Production costs and logistics constitute major barriers; on-site cyclotron operation is essential for supply security.
• Alternative tracers, especially Rubidium-82, pose competitive threats, prompting continuous innovation.
• Investment in R&D and strategic partnerships is crucial for companies aiming to expand in this niche market.

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FAQs

1. What are the leading competitors producing Ammonia N-13?
   Thermo Fisher Scientific and Bracco Diagnostics are primary suppliers.

2. How does the short half-life affect the market?
   It restricts distribution to nearby facilities, limiting market reach and necessitating on-site production.

3. What regions are experiencing higher growth?
   North America remains the largest market, with Asia-Pacific showing the fastest expansion due to healthcare infrastructure improvements.

4. Are regulatory approvals easy to obtain?
   Not necessarily; approvals depend on regional agencies' standards, with extensive safety and efficacy data required.

5. What future developments could impact the market?
   Enhanced PET imaging technology, new radiotracers competing with N-13, and policies supporting nuclear medicine could reshape demand.

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References

[1] World Health Organization. (2021). Cardiovascular diseases. WHO Fact Sheet No. 317.
[2] Boellaard, R. et al. (2015). European Association of Nuclear Medicine procedure guidelines for tumor PET imaging. European Journal of Nuclear Medicine and Molecular Imaging, 42(2), 328-354.
[3] U.S. Food and Drug Administration. (2022). New Drug Approvals Calendar.
[4] Verbruggen, A. et al. (2017). Superiority of Rubidium-82 PET in myocardial perfusion imaging. Journal of Nuclear Medicine, 58(1), 101-106.