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Last Updated: June 27, 2022

Details for New Drug Application (NDA): 022244


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NDA 022244 describes LUSEDRA, which is a drug marketed by Eisai Inc and is included in one NDA. There is one patent protecting this drug. Additional details are available on the LUSEDRA profile page.

The generic ingredient in LUSEDRA is fospropofol disodium. Additional details are available on the fospropofol disodium profile page.
Summary for 022244
Tradename:LUSEDRA
Applicant:Eisai Inc
Ingredient:fospropofol disodium
Patents:1
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 022244
Generic Entry Date for 022244*:
Constraining patent/regulatory exclusivity:
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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength1050MG/30ML (35MG/ML)
Approval Date:Dec 12, 2008TE:RLD:No
Patent:See Plans and PricingPatent Expiration:Jul 1, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:SEDATIVE-HYPNOTIC AGENT INDICATED FOR MONITORED ANESTHESIA CARE (MAC) SEDATION

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