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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, Amneal Pharms, Mylan Technologies, Zydus Noveltech Inc, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orchid Hlthcare, Sun Pharm, and Watson Labs, and is included in seventeen 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. Eight 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:	15
NDAs:	17
Drug Master File Entries:	32
Suppliers / Packagers:	8
Bulk Api Vendors:	64
Clinical Trials:	85
Patent Applications:	6,144
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for rivastigmine
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)-

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

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 (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

Generic filers with tentative approvals for RIVASTIGMINE

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

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-002	Jul 6, 2007	AB	RX	Yes	Yes			Y
Macleods Pharms Ltd	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	203148-002	Aug 22, 2014	AB	RX	No	No
Sun Pharm	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	077131-002	Oct 22, 2007	AB	RX	No	No
Sun Pharm	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	077131-004	Oct 22, 2007	AB	RX	No	No
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-006	Apr 21, 2000	AB	RX	Yes	Yes

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	022083-005	Aug 31, 2012
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-005	Aug 31, 2012
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-001	Jul 6, 2007
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-005	Aug 31, 2012

International Patents for rivastigmine

Country	Patent Number	Estimated Expiration
Brazil	9906920
Indonesia	27503
Hungary	227159
Israel	137100
Turkey	200101021

Supplementary Protection Certificates for rivastigmine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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