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Last Updated: May 12, 2024

Sodium fluoride f-18 - Generic Drug Details

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

Sodium fluoride f-18 is the generic ingredient in three branded drugs marketed by Ge Healthcare, Nih Nci Dctd, 3d Imaging Drug, Bamf, Biomedcl Res Fdn, Cardinal Health 414, Decatur, Essential Isotopes, Hot Shots Nm Llc, Jubilant Draximage, Kreitchman Pet Ctr, Mcprf, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Nukemed, Petnet, Precision Nuclear, Shertech Labs Llc, Sofie, The Feinstein Inst, Ucsf Rodiopharm, Uihc Pet Imaging, Univ Tx Md Anderson, and Univ Utah Cyclotron, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

Eleven suppliers are listed for this compound.

Summary for sodium fluoride f-18

US Patents:	0
Tradenames:	3
Applicants:	25
NDAs:	26
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	116
Patent Applications:	31
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in sodium fluoride f-18?	sodium fluoride f-18 excipients list
DailyMed Link:	sodium fluoride f-18 at DailyMed

Recent Clinical Trials for sodium fluoride f-18

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

Sponsor	Phase
Dr. D. Y. Patil Dental College & Hospital	Phase 3
Jasberry Healthcare Pvt. Ltd	Phase 3
HALEON	N/A

See all sodium fluoride f-18 clinical trials

Pharmacology for sodium fluoride f-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

Medical Subject Heading (MeSH) Categories for sodium fluoride f-18

Cariostatic Agents

Anatomical Therapeutic Chemical (ATC) Classes for sodium fluoride f-18

A01AA	Caries prophylactic agents
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A12CD	Fluoride
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for sodium fluoride 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
3d Imaging Drug	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	203777-001	Oct 19, 2015	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bamf	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	216126-001	Dec 6, 2022	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Kreitchman Pet Ctr	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	203936-001	May 19, 2016	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Univ Tx Md Anderson	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	203247-001	Dec 23, 2013		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ge Healthcare	FLUORINE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	017042-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hot Shots Nm Llc	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	204530-001	Jul 29, 2015	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Petnet	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	203890-001	Sep 28, 2015	AP	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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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