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Last Updated: June 27, 2022

EXELON Drug Patent 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. Ten suppliers are listed for this compound. Additional details are available on the rivastigmine profile page.

DrugPatentWatch® 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

See drug prices for EXELON

Recent Clinical Trials for EXELON

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

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

See all EXELON clinical trials

Pharmacology for EXELON
Anatomical Therapeutic Chemical (ATC) Classes for EXELON
Paragraph IV (Patent) Challenges for EXELON
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EXELON Transdermal System Extended-release rivastigmine 13.3 mg/24 hr 022083 1 2013-01-22
EXELON Transdermal System Extended-release rivastigmine 4.6 mg/24 hr and 9.5 mg/24 hr 022083 1 2011-04-27
EXELON Oral Solution rivastigmine tartrate 2 mg/mL 021025 1 2004-11-05
EXELON Capsules rivastigmine tartrate 1.5 mg, 3 mg, 4.5 mg and 6 mg 020823 3 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-006 Apr 21, 2000 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis EXELON rivastigmine tartrate SOLUTION;ORAL 021025-001 Apr 21, 2000 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-004 Apr 21, 2000 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-005 Apr 21, 2000 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-002 Jul 6, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-002 Jul 6, 2007 See Plans and Pricing See Plans and Pricing
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-004 Apr 21, 2000 See Plans and Pricing See Plans and Pricing
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-001 Jul 6, 2007 See Plans and Pricing See Plans and Pricing
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-005 Apr 21, 2000 See Plans and Pricing See Plans and Pricing
Novartis EXELON rivastigmine tartrate SOLUTION;ORAL 021025-001 Apr 21, 2000 See Plans and Pricing See Plans and Pricing
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-003 Apr 21, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for EXELON

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Actavis Group PTC ehf Rivastigmine Actavis rivastigmine EMEA/H/C/002036
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Authorised yes no no 2011-06-16
Krka, d.d., Novo mesto Nimvastid rivastigmine EMEA/H/C/001029
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Authorised yes no no 2009-05-11
1 A Pharma GmbH Rivastigmine 1 A Pharma rivastigmine EMEA/H/C/001181
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Authorised no no no 2009-12-11
Novartis Europharm Limited Exelon rivastigmine EMEA/H/C/000169
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Authorised no no no 1998-05-11
Novartis Europharm Limited Prometax rivastigmine EMEA/H/C/000255
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Authorised no no no 1998-12-03
Sandoz GmbH Rivastigmine Sandoz rivastigmine EMEA/H/C/001183
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Authorised no no no 2009-12-10
Hexal AG  Rivastigmine Hexal rivastigmine EMEA/H/C/001182
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Authorised no no no 2009-12-11
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for EXELON

See the table below for patents covering EXELON around the world.

Country Patent Number Title Estimated Expiration
Australia 5428486 See Plans and Pricing
Austria 223711 See Plans and Pricing
Japan S63238054 PHENYLCARBAMATE See Plans and Pricing
Slovenia 1047409 See Plans and Pricing
Luxembourg 87150 See Plans and Pricing
Netherlands 980031 See Plans and Pricing
Greece 1000023 ΚΑΡΒΑΜΙΚΟΣ ΦΑΙΝΥΛΕΣΤΗΡ. (CARBAMIC PHENYLESTER) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EXELON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0193926 C980031 Netherlands See Plans and Pricing 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 SPC/GB98/041 United Kingdom See Plans and Pricing 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
0193926 98C0038 Belgium See Plans and Pricing PRODUCT NAME: RIVASTIGMINE; NAT. REGISTRATION NO/DATE: EU/1/98/066/001 19980512; FIRST REGISTRATION: CH 54275 01 19970731
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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