EXELON Drug Patent Profile

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 31^st, 2015.

Summary for EXELON

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	39
Patent Applications:	4,023
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EXELON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXELON
What excipients (inactive ingredients) are in EXELON?	EXELON excipients list
DailyMed Link:	EXELON at DailyMed

See drug prices for EXELON

Recent Clinical Trials for EXELON

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

Sponsor	Phase
Ain Shams University	Phase 1/Phase 2
SocraTec R&D GmbH	Phase 1
SocraMetrics GmbH	Phase 1

See all EXELON clinical trials

Pharmacology for EXELON

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EXELON

N06DA	Anticholinesterases
N06D	ANTI-DEMENTIA DRUGS
N06	PSYCHOANALEPTICS
N	Nervous system

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
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-005	Aug 31, 2012	AB	RX	Yes	No
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-006	Apr 21, 2000		DISCN	Yes	No
Novartis	EXELON	rivastigmine tartrate	SOLUTION;ORAL	021025-001	Apr 21, 2000		DISCN	No	No
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-004	Apr 21, 2000		DISCN	Yes	No
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-005	Apr 21, 2000		DISCN	Yes	No
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-002	Jul 6, 2007	AB	RX	Yes	Yes

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
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-002	Jul 6, 2007
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-004	Apr 21, 2000
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-001	Jul 6, 2007
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-005	Apr 21, 2000
Novartis	EXELON	rivastigmine tartrate	SOLUTION;ORAL	021025-001	Apr 21, 2000
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-003	Apr 21, 2000

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

International Patents for EXELON

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

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

Supplementary Protection Certificates for EXELON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0193926	C980031	Netherlands		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		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		PRODUCT NAME: RIVASTIGMINE; NAT. REGISTRATION NO/DATE: EU/1/98/066/001 19980512; FIRST REGISTRATION: CH 54275 01 19970731