Details for New Drug Application (NDA): 203137

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NDA 203137 describes VIZAMYL, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the VIZAMYL profile page.

The generic ingredient in VIZAMYL is flutemetamol f-18. One supplier is listed for this compound. Additional details are available on the flutemetamol f-18 profile page.

Summary for 203137

Tradename:	VIZAMYL
Applicant:	Ge Healthcare
Ingredient:	flutemetamol f-18
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 203137

Generic Entry Date for 203137^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: INJECTABLE;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.

Pharmacology for NDA: 203137

Mechanism of Action	Radiopharmaceutical Activity

Suppliers and Packaging for NDA: 203137

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137	NDA	Medi-Physics, Inc. dba GE Healthcare	17156-067	17156-067-30	1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-30) / 30 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	40.5mCi/10ML (4.05mCi/ML)
Approval Date:	Oct 25, 2013	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 3, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	DIAGNOSTIC RADIOIMAGING
Patent:	⤷ Sign Up	Patent Expiration:	May 21, 2024	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Sep 16, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 203137

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013	⤷ Sign Up	⤷ Sign Up
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013	⤷ Sign Up	⤷ Sign Up
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.