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Last Updated: November 4, 2024

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*:
Constraining patent/regulatory exclusivity:
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 ActionRadiopharmaceutical 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:DISCNDosage:INJECTABLE;INTRAVENOUSStrength40.5mCi/10ML (4.05mCi/ML)
Approval Date:Oct 25, 2013TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Sep 3, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:DIAGNOSTIC RADIOIMAGING
Patent:⤷  Sign UpPatent Expiration:May 21, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Sep 16, 2028Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 203137

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 203137-002 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 203137-001 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.