Details for New Drug Application (NDA): 213535

NDA 213535 describes EVRYSDI, which is a drug marketed by Genentech Inc and is included in two NDAs. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the EVRYSDI profile page.

The generic ingredient in EVRYSDI is risdiplam. One supplier is listed for this compound. Additional details are available on the risdiplam profile page.

Summary for 213535

Tradename:	EVRYSDI
Applicant:	Genentech Inc
Ingredient:	risdiplam
Patents:	7

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 213535

Dosage:

FOR SOLUTION;ORAL

^*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: 213535

Mechanism of Action	Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors Survival of Motor Neuron 2 Splicing Modifiers
Physiological Effect	Increased Protein Synthesis

Suppliers and Packaging for NDA: 213535

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EVRYSDI	risdiplam	FOR SOLUTION;ORAL	213535	NDA	Genentech, Inc.	50242-175	50242-175-07	1 BOTTLE, GLASS in 1 CARTON (50242-175-07) / 80 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	0.75MG/ML
Approval Date:	Aug 7, 2020	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 3, 2026
Regulatory Exclusivity Use:	INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION
Regulatory Exclusivity Expiration:	Aug 7, 2025
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	May 27, 2025
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

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