Last Updated: October 1, 2026

Details for New Drug Application (NDA): 219908


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NDA 219908 describes REVTORPYK, which is a drug marketed by Celcuity and is included in one NDA. It is available from one supplier. Additional details are available on the REVTORPYK profile page.

The generic ingredient in REVTORPYK is gedatolisib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gedatolisib profile page.
Summary for 219908
Tradename:REVTORPYK
Applicant:Celcuity
Ingredient:gedatolisib
Patents:0
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219908
Generic Entry Date for 219908*:

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Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

POWDER;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.

Suppliers and Packaging for NDA: 219908
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REVTORPYK gedatolisib POWDER;INTRAVENOUS 219908 NDA Celcuity Inc. 84577-751 84577-751-01 1 VIAL, GLASS in 1 CARTON (84577-751-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength180MG/VIAL
Approval Date:Jul 14, 2026TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 14, 2031
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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