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Last Updated: January 15, 2021

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Details for New Drug Application (NDA): 022083

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NDA 022083 describes EXELON, which is a drug marketed by Novartis and is included in three NDAs. It is available from two suppliers. Additional details are available on the EXELON profile page.

The generic ingredient in EXELON is rivastigmine. There are thirty-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the rivastigmine profile page.
Summary for 022083
Tradename:EXELON
Applicant:Novartis
Ingredient:rivastigmine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 022083
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 022083
Suppliers and Packaging for NDA: 022083
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083 NDA Novartis Pharmaceuticals Corporation 0078-0501 0078-0501-15 30 PATCH in 1 CARTON (0078-0501-15) > 24 h in 1 PATCH (0078-0501-61)
EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083 NDA Novartis Pharmaceuticals Corporation 0078-0502 0078-0502-15 30 PATCH in 1 CARTON (0078-0502-15) > 24 h in 1 PATCH (0078-0502-61)
Paragraph IV (Patent) Challenges for 022083
Tradename Dosage Ingredient NDA Submissiondate
EXELON FILM, EXTENDED RELEASE;TRANSDERMAL rivastigmine 022083 2013-01-22
EXELON FILM, EXTENDED RELEASE;TRANSDERMAL rivastigmine 022083 2011-04-27

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength4.6MG/24HR
Approval Date:Jul 6, 2007TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength9.5MG/24HR
Approval Date:Jul 6, 2007TE:ABRLD:Yes

Profile for product number 005

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength13.3MG/24HR
Approval Date:Aug 31, 2012TE:ABRLD:Yes

Expired US Patents for NDA 022083

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-001 Jul 6, 2007   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-002 Jul 6, 2007   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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