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Last Updated: November 22, 2024

FLUDEOXYGLUCOSE F-18 - Generic Drug Details

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What are the generic drug sources for fludeoxyglucose f-18 and what is the scope of freedom to operate?

Fludeoxyglucose f-18 is the generic ingredient in one branded drug marketed by Downstate Clincl, 3d Imaging Drug, Biomedcl Res Fdn, Brigham Womens, Cardinal Health 414, Childrens Hosp Mi, Decatur, Essential Isotopes, Feinstein, Hot Shots Nm Llc, Isologic Innovative, Jubilant Draximage, Kettering Medctr, Kreitchman Pet Ctr, Ma General Hosp, Mcprf, Mem Sloan-kettering, Methodist Hosp Res, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Northland, Nukemed, Petnet, Pharmalogic, Pharmalogic Hldgs, Precision Nuclear, Queen Hamamatsu Pet, Sofie, Trustees Univ Pa, Ucla Biomedical, Ucsf Rodiopharm, Uihc Pet Imaging, Univ Michigan, Univ Southern Ca, Univ Tx Md Anderson, Univ Tx Sw Medctr, Univ Utah Cyclotron, Weill Medcl Coll, Wisconsin, and Wusm Cyclotron, and is included in forty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for fludeoxyglucose f-18. Twenty-six suppliers are listed for this compound.

Summary for FLUDEOXYGLUCOSE F-18

US Patents:	0
Tradenames:	1
Applicants:	41
NDAs:	43
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	183
Patent Applications:	1,672
What excipients (inactive ingredients) are in FLUDEOXYGLUCOSE F-18?	FLUDEOXYGLUCOSE F-18 excipients list
DailyMed Link:	FLUDEOXYGLUCOSE F-18 at DailyMed

Recent Clinical Trials for FLUDEOXYGLUCOSE F-18

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

Sponsor	Phase
Robert Flavell, MD, PhD	Phase 1
Michael Topf	Phase 1
Xencor, Inc.	Phase 1

See all FLUDEOXYGLUCOSE F-18 clinical trials

Pharmacology for FLUDEOXYGLUCOSE F-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

Anatomical Therapeutic Chemical (ATC) Classes for FLUDEOXYGLUCOSE F-18

US Patents and Regulatory Information for FLUDEOXYGLUCOSE F-18

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Essential Isotopes	FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	203946-001	Feb 5, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Wisconsin	FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	203709-001	Oct 23, 2013	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Uihc Pet Imaging	FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	203990-001	Aug 6, 2014	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Wusm Cyclotron	FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	203935-001	Feb 5, 2014	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharmalogic	FLUDEOXYGLUCOSE F18	fludeoxyglucose f-18	INJECTABLE;INTRAVENOUS	204264-001	Dec 18, 2014	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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