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Last Updated: August 7, 2020

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EXELON Drug Profile

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When do Exelon patents expire, and when can generic versions of Exelon launch?

Exelon is a drug marketed by Novartis and is included in three NDAs.

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.

US ANDA Litigation and Generic Entry Outlook for Exelon

A generic version of EXELON was approved as rivastigmine by ALVOGEN on August 31st, 2015.

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Drug patent expirations by year for EXELON
Drug Prices for EXELON

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Recent Clinical Trials for EXELON

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ain Shams UniversityPhase 1/Phase 2
SocraMetrics GmbHPhase 1
SocraTec R&D GmbHPhase 1

See all EXELON clinical trials

Pharmacology for EXELON
Paragraph IV (Patent) Challenges for EXELON
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
EXELON SOLUTION;ORAL rivastigmine tartrate 021025 2004-11-05
EXELON CAPSULE;ORAL rivastigmine tartrate 020823 2004-04-21

US Patents and Regulatory Information for EXELON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-003 Apr 21, 2000 DISCN Yes No   Start Trial   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-006 Apr 21, 2000 DISCN Yes No   Start Trial   Start Trial   Start Trial
Novartis EXELON rivastigmine tartrate SOLUTION;ORAL 021025-001 Apr 21, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for EXELON

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-002 Jul 6, 2007   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-001 Jul 6, 2007   Start Trial   Start Trial
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-005 Apr 21, 2000   Start Trial   Start Trial
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-003 Apr 21, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for EXELON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0193926 C980031 Netherlands   Start Trial PRODUCT NAME: RIVASTIGMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER RIVASTIGMINE WATERSTOFTAR- TRAAT; REGISTRATION NO/DATE: EU/1/98/066/001 - EU/1/98/066/012 19980512
0193926 98C0038 Belgium   Start Trial PRODUCT NAME: RIVASTIGMINE; NAT. REGISTRATION NO/DATE: EU/1/98/066/001 19980512; FIRST REGISTRATION: CH 54275 01 19970731
0193926 SPC/GB98/041 United Kingdom   Start Trial PRODUCT NAME: RIVASTIGMINE, AS FREE BASE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5427501 19970731; CH 5427502 19970731; CH 5427503 19970731; CH 5427504 19970731; CH 5427505 19970731; CH 5427506 19970731; UK EU/1/98/066/001 19980512; UK EU/1/98/066/002 19980512; UK EU/1/98/066/003 19980512; UK EU/1/98/066/004 19980512; UK EU/1/98/066/005 19980512; UK EU/1/98/066/006 19980512; UK EU/1/98/092/023 19980512; UK EU/1/98/092/024 19980512; UK EU/1/98/092/025 19980512; UK EU/1/98/092/026 19980512; UK EU/1/98/066/025 19980512; UK EU/1/98/066/026 19980512; UK EU/1/98/092/019 19980512; UK EU/1/98/092/020 19980512; UK EU/1/98/092/021 19980512; UK EU/1/98/092/022 19980512; UK EU/1/98/0
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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