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Last Updated: June 4, 2020

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Ammonia n-13 - Generic Drug Details

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What are the generic sources for ammonia n-13 and what is the scope of patent protection?

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

There are two drug master file entries for ammonia n-13. Eighteen suppliers are listed for this compound.

Summary for ammonia n-13
Recent Clinical Trials for ammonia n-13

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

SponsorPhase
Marcelo F. Di Carli, MD, FACCPhase 4
Ronnie Fass, MDPhase 3
Asian Institute of Gastroenterology, IndiaPhase 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
Feinstein AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 022119-001 Aug 23, 2007 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Essential Isotopes AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 205687-001 Dec 17, 2015 RX No No   Start Trial   Start Trial   Start Trial
Decatur AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 204465-001 Oct 23, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Wa Univ Sch Med AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 204506-001 Feb 7, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Johns Hopkins Univ AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 204514-001 Aug 19, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Univ Tx Sw Medctr AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 209507-001 Nov 1, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Precision Nuclear AMMONIA N 13 ammonia n-13 INJECTABLE;INTRAVENOUS 204547-001 Aug 14, 2015 RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Merck
AstraZeneca
Boehringer Ingelheim
Johnson and Johnson

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