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Last Updated: July 5, 2020

DrugPatentWatch Database Preview

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 five 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
Applicant:Ge Healthcare
Ingredient:flutemetamol f-18
Generic Entry Opportunity Date for 203137
Generic Entry Date for 203137*:
Constraining patent/regulatory exclusivity:

*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:  Start TrialPatent Expiration:Sep 3, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Jan 24, 2023Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:May 21, 2024Product Flag?YSubstance Flag?YDelist Request?

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