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Rivastigmine - Generic Drug Details

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What are the generic drug sources for rivastigmine and what is the scope of rivastigmine freedom to operate?

Rivastigmine is the generic ingredient in three branded drugs marketed by Novartis, Alvogen Malta, Mylan Technologies, Ajanta Pharma Ltd, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orchid Hlthcare, Sun Pharm Inds Ltd, and Watson Labs, and is included in fifteen NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Rivastigmine has thirty-seven patent family members in twenty-seven countries.

There are thirty-two drug master file entries for rivastigmine. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for rivastigmine

International Patents:	37
US Patents:	2
Tradenames:	3
Applicants:	13
NDAs:	15
Drug Master File Entries:	32
Suppliers / Packagers:	6
Bulk Api Vendors:	61
Clinical Trials:	79
Patent Applications:	6,460
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rivastigmine
DailyMed Link:	rivastigmine at DailyMed

Pharmacology for rivastigmine

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for rivastigmine

Cholinesterase Inhibitors

Neuroprotective Agents

Synonyms for rivastigmine

(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)-

CC-34273

CCG-221197

CHEBI:8874

CHEMBL636

CS-0946

D03822

D0WY5Q

DB00989

DR000673

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

Exelon Patch

Exelon; Rivastigmine hydrogen tartrate; 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 ethylmethylc

F10108

FT-0651952

GTPL6602

HMS2089H18

HY-17368

I06-2037

KS-00000H18

LS-172571

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

MFCD00871496

MLS003876822

MolPort-003-666-662

NCGC00167531-03

Nimvastid

OR210090

PKI06M3IW0

Prometax

Prometax (TN)

Rivastigmine (JAN/USAN/INN)

Rivastigmine (transdermal patch)

Rivastigmine [USAN:INN:BAN:JAN]

Rivastigmine [USAN:INN]

rivastigmine hexal

Rivastigmine Teva

Rivastigmine Transdermal System

Rivastigmine.tartrate

RL06150

S-Rivastigmine

S4687

SCHEMBL2764

SDZ 212-713

SDZ-212-713

SDZ-ENA-713

SMR002203623

ST24049123

UNII-PKI06M3IW0

W-200966

W-5183

XSVMFMHYUFZWBK-NSHDSACASA-N

Y9059

ZINC4413

Tentative approvals for RIVASTIGMINE

Applicant	Application No.	Strength	Dosage Form
		2MG/ML	SOLUTION; ORAL

US Patents and Regulatory Information for rivastigmine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Ltd	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	077131-004	Oct 22, 2007	AB	RX	No	No
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-001	Jul 6, 2007	AB	RX	Yes	No			Y
Cadila Pharms Ltd	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	203844-001	Feb 13, 2017	AB	RX	No	No
Aurobindo Pharma Ltd	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	204572-004	Mar 25, 2016	AB	RX	No	No

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Expired US Patents for rivastigmine

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	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-001	Jul 6, 2007
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-001	Jul 6, 2007

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International Patents for rivastigmine

Country	Document Number	Estimated Expiration
Australia	2278599
New Zealand	505650
Norway	328390
Germany	69902875

Supplementary Protection Certificates for rivastigmine

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
80031	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
C/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
C0038	Belgium		PRODUCT NAME: RIVASTIGMINE; NAT. REGISTRATION NO/DATE: EU/1/98/066/001 19980512; FIRST REGISTRATION: CH 54275 01 19970731