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Last Updated: December 9, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 213793


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NDA 213793 describes IMCIVREE, which is a drug marketed by Rhythm and is included in one NDA. There are three patents protecting this drug. Additional details are available on the IMCIVREE profile page.

The generic ingredient in IMCIVREE is setmelanotide acetate. Additional details are available on the setmelanotide acetate profile page.
Summary for 213793
Tradename:IMCIVREE
Applicant:Rhythm
Ingredient:setmelanotide acetate
Patents:3
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 213793
Generic Entry Date for 213793*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS

*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:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 10MG/ML BASE (EQ 10MG/ML BASE)
Approval Date:Nov 25, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 25, 2027
Regulatory Exclusivity Use:INDICATED FOR CHRONIC WEIGHT MANAGEMENT IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH OBESITY DUE TO PROOPIOMELANOCORTIN (POMC), PROPROTEIN CONVERTASE SUBTILISIN/KEXIN TYPE 1 (PCSK1), OR LEPTIN RECEPTOR (LEPR) DEFICIENCY CONFIRMED BY GENETIC TESTING DEMONSTRATING VARIANTS IN POMC, PCSK1, OR LEPR GENES THAT ARE INTERPRETED AS PATHOGENIC, LIKELY PATHOGENIC, OR OF UNCERTAIN SIGNIFICANCE (VUS)
Regulatory Exclusivity Expiration:Nov 25, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Try it FreePatent Expiration:Jul 4, 2034Product Flag?YSubstance Flag?Delist Request?

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