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Last Updated: December 7, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 213535


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NDA 213535 describes EVRYSDI, which is a drug marketed by Genentech Inc and is included in one NDA. It is available from one supplier. There are two 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:2
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 213535
Generic Entry Date for 213535*:
Constraining patent/regulatory exclusivity:
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.

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:RXDosage:FOR SOLUTION;ORALStrength0.75MG/ML
Approval Date:Aug 7, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 7, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Aug 7, 2027
Regulatory Exclusivity Use:TREATMENT OF SPINAL MUSCULAR ATROPHY (SMA) IN PATIENTS 2 MONTHS OF AGE AND OLDER
Patent:⤷  Try it FreePatent Expiration:Feb 8, 2033Product Flag?YSubstance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

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