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EXELON Drug Profile

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Which patents cover Exelon, and what generic alternatives are available?

Exelon is a drug marketed by Novartis and is included in three NDAs. There are two patents protecting this drug and four Paragraph IV challenges.

This drug has thirty-seven patent family members in twenty-seven countries.

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.

US ANDA Litigation and Generic Entry Outlook for Exelon

A generic version of EXELON was approved as rivastigmine by ALVOGEN on January 18^th, 2020.

Summary for EXELON

International Patents:	37
US Patents:	2
Applicants:	1
NDAs:	3
Suppliers / Packagers:	2
Bulk Api Vendors:	68
Clinical Trials:	28
Patent Applications:	4,640
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EXELON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXELON
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
SocraTec R&D GmbH	Phase 1
SocraMetrics GmbH	Phase 1
University of Pennsylvania	Phase 4

See all EXELON clinical trials

Recent Litigation for EXELON

Identify potential future generic entrants

District Court Litigation

Case Name	Date
NOVARTIS PHARMACEUTICALS CORPORATION v. DR. REDDYS LABORATORIES, LTD.	2015-11-06
Novartis Pharmaceuticals Corporation v. Amneal Pharmaceuticals LLC	2015-11-05
Novartis Pharmaceuticals Corporation v. Dr. Reddy's Laboratories, Ltd.	2015-11-05

See all EXELON litigation

PTAB Litigation

Petitioner	Date
Mylan Pharmaceuticals Inc.	2014-11-13
Noven Pharmaceuticals, Inc.	2014-04-02

See all EXELON litigation

Pharmacology for EXELON

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Synonyms for EXELON

(R)-Rivastigmine (Rivastigmine EP Impurity D)

(S)-1-(3-((ethyl(methyl)carbamoyl)oxy)phenyl)-N,N-dimethylethanamine

(S)-3-(1-(dimethylamino)ethyl)phenyl ethyl(methyl)carbamate

(S)-3-(1-(Dimethylamino)ethyl)phenyl ethylmethylcarbamate

(S)-3-[1-(dimethylamino)ethyl]phenyl N-ethyl-N-methylcarbamate

[3-[(1S)-1-(dimethylamino)ethyl]phenyl] N-ethyl-N-methyl-carbamate

[3-[(1S)-1-(dimethylamino)ethyl]phenyl] N-ethyl-N-methylcarbamate

[3-[(1S)-1-dimethylaminoethyl]phenyl] N-ethyl-N-methylcarbamate

101R548

123441-03-2

2,3-dihydroxybutanedioic acid; 3-[(1S)-1-(dimethylamino)ethyl]phenyl N-ethyl-N-methylcarbamate

3-((1S)-1-(Dimethylamino)ethyl)phenyl N-ethyl-N-methylcarbamate

3-((1S)-1-(Dimethylamino)ethyl)phenyl N-ethyl-N-methylcarbamate; Ethylmethylcarbamic acid 3-((1S)-1-(dimethylamino)ethyl)phenyl ester

3-((1S)-1-(Dimethylamino)ethyl)phenyl ethylmethylcarbamate

3-((1S)-1-(Dimethylamino)ethyl)phenyl N-ethyl N-methyl carbamate

3-[(1S)-1-(dimethylamino)ethyl]phenyl ethyl(methyl)carbamate

3-[(1S)-1-(dimethylamino)ethyl]phenyl N-ethyl-N-methylcarbamate

AB01275472_02

AB01275472_03

AB01275472-01

AB1004572

ABP001082

AC-8250

AC1L2U92

AJ-08211

AK161672

AKOS015896334

AN-1074

API0008913

BC225687

BDBM10620

BDBM11682

BIDD:GT0316

C-23825

C11766

Carbamic acid, ethylmethyl-, 3-((1S)-1-(dimethylamino)ethyl)phenyl ester

Carbamic acid, ethylmethyl-, 3-(1-(dimethylamino)ethyl)phenyl ester, (S)-

Carbamic acid, N-ethyl-N-methyl-, 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester

CC-34273

CCG-221197

CHEBI:8874

CHEMBL636

CS-0946

D03822

DB00989

DTXSID7023564

EBD46209

ENA 713 free base

ENA-713

Ethyl-methyl-carbamic acid 3-((R)-1-dimethylamino-ethyl)-phenyl ester

Ethyl-methyl-carbamic acid 3-((S)-1-dimethylamino-ethyl)-phenyl ester

Ethyl-methyl-carbamic acid 3-(1-dimethylamino-ethyl)-phenyl ester

Ethylmethylcarbamic acid 3-((1S)-1-(dimethylamino)ethyl)phenyl ester

Exelon Patch

F10108

FT-0651952

GTPL6602

HMS2089H18

HMS3715P15

HY-17368

I06-2037

KS-00000H18

LS-172571

m-((S)-1-(Dimethylamino)ethyl)phenyl ethylmethylcarbamate

MLS003876822

MolPort-003-666-662

NCGC00167531-03

Nimvastid

PKI06M3IW0

Prometax (TN)

rivastigmine

Rivastigmine (JAN/USAN/INN)

Rivastigmine [USAN:INN:BAN:JAN]

Rivastigmine [USAN:INN]

Rivastigmine Teva

Rivastigmine Transdermal System

Rivastigmine.tartrate

RL06150

S4687

SCHEMBL2764

SDZ 212-713

SDZ-212-713

SDZ-ENA-713

SMR002203623

SR-05000001475

SR-05000001475-1

SR-05000001475-2

ST24049123

UNII-PKI06M3IW0

W-200966

W-5183

XSVMFMHYUFZWBK-NSHDSACASA-N

Y9059

ZINC4413

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
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-002	Jul 6, 2007	AB	RX	Yes	Yes			Y
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-006	Apr 21, 2000		DISCN	Yes	No
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-002	Jul 6, 2007	AB	RX	Yes	Yes			Y
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	022083-001	Jul 6, 2007	AB	RX	Yes	No			Y

Expired US Patents for EXELON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-005	Apr 21, 2000
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-001	Jul 6, 2007
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-002	Jul 6, 2007
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-003	Apr 21, 2000
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-002	Jul 6, 2007
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-006	Apr 21, 2000
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-001	Jul 6, 2007

International Patents for EXELON

Country	Patent Number	Estimated Expiration
Poland	201328
South Korea	100569051
World Intellectual Property Organization (WIPO)	9934782
Japan	2002500178
Denmark	1047409
Hungary	0004300
European Patent Office	1047409

Supplementary Protection Certificates for EXELON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0193926	98C0038	Belgium		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		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	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