FLUOROESTRADIOL F-18 - Generic Drug Details

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

Fluoroestradiol f-18 is the generic ingredient in one branded drug marketed by Ge Healthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for FLUOROESTRADIOL F-18

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	23
Patent Applications:	44
DailyMed Link:	FLUOROESTRADIOL F-18 at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FLUOROESTRADIOL F-18

Generic Entry Date for FLUOROESTRADIOL F-18^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY Dosage: SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FLUOROESTRADIOL F-18

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

Sponsor	Phase
Jiangsu HengRui Medicine Co., Ltd.	Phase 3
Peking Union Medical College Hospital	Phase 3
Abramson Cancer Center of the University of Pennsylvania	Early Phase 1

See all FLUOROESTRADIOL F-18 clinical trials

Pharmacology for FLUOROESTRADIOL F-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

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

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for FLUOROESTRADIOL F-18

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Glossary

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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
Ge Healthcare	CERIANNA	fluoroestradiol f-18	SOLUTION;INTRAVENOUS	212155-001	May 20, 2020		RX	Yes	Yes	⤷ 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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