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Last Updated: March 29, 2024

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 four 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:4
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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: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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.